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  • R-TF-015-002 Preclinical and clinical evaluation record_2023_001

R-TF-015-002 Preclinical and clinical evaluation record_2023_001

Scope​

This literature review compiles and evaluates state-of-the-art publications on computer vision in medicine. The overall objective of this strategy is to identify, select and collect the relevant literature to determine whether the device can achieve its intended purpose.

Medical device information​

Manufacturer contact details​

Manufacturer data
Legal manufacturer nameAI Labs Group S.L.
AddressStreet Gran Vía 1, BAT Tower, 48001, Bilbao, Bizkaia (Spain)
SRNES-MF-000025345
Person responsible for regulatory complianceAlfonso Medela, Saray Ugidos
E-mailoffice@legit.health
Phone+34 638127476
TrademarkLegit.Health

Medical device characterization​

Information
Device nameLegit.Health Plus (hereinafter, the device)
Model and typeNA
Version1.1.0.0
Basic UDI-DI8437025550LegitCADx6X
Certificate number (if available)MDR 792790
EMDN code(s)Z12040192 (General medicine diagnosis and monitoring instruments - Medical device software)
GMDN code65975
ClassClass IIb
Classification ruleRule 11
Novel product (True/False)FALSE
Novel related clinical procedure (True/False)FALSE
SRNES-MF-000025345

Intended purpose​

Intended use​

The device is a computational software-only medical device intended to support health care providers in the assessment of skin structures, enhancing efficiency and accuracy of care delivery, by providing:

  • quantification of intensity, count, extent of visible clinical signs
  • interpretative distribution representation of possible International Classification of Diseases (ICD) categories.

Quantification of intensity, count and extent of visible clinical signs​

The device provides quantifiable data on the intensity, count and extent of clinical signs such as erythema, desquamation, and induration, among others; including, but not limited to:

  • erythema,
  • desquamation,
  • induration,
  • crusting,
  • xerosis (dryness),
  • swelling (oedema),
  • oozing,
  • excoriation,
  • lichenification,
  • exudation,
  • wound depth,
  • wound border,
  • undermining,
  • hair loss,
  • necrotic tissue,
  • granulation tissue,
  • epithelialization,
  • nodule,
  • papule
  • pustule,
  • cyst,
  • comedone,
  • abscess,
  • draining tunnel,
  • inflammatory lesion,
  • exposed wound, bone and/or adjacent tissues,
  • slough or biofilm,
  • maceration,
  • external material over the lesion,
  • hypopigmentation or depigmentation,
  • hyperpigmentation,
  • scar,
  • ictericia

Image-based recognition of visible ICD categories​

The device is intended to provide an interpretative distribution representation of possible International Classification of Diseases (ICD) categories that might be represented in the pixels content of the image.

Device description​

The device is a computational software-only medical device leveraging computer vision algorithms to process images of the epidermis, the dermis and its appendages, among other skin structures. Its principal function is to provide a wide range of clinical data from the analyzed images to assist healthcare practitioners in their clinical evaluations and allow healthcare provider organisations to gather data and improve their workflows.

The generated data is intended to aid healthcare practitioners and organizations in their clinical decision-making process, thus enhancing the efficiency and accuracy of care delivery.

The device should never be used to confirm a clinical diagnosis. On the contrary, its result is one element of the overall clinical assessment. Indeed, the device is designed to be used when a healthcare practitioner chooses to obtain additional information to consider a decision.

Intended medical indication​

The device is indicated for use on images of visible skin structure abnormalities to support the assessment of all diseases of the skin incorporating conditions affecting the epidermis, its appendages (hair, hair follicle, sebaceous glands, apocrine sweat gland apparatus, eccrine sweat gland apparatus and nails) and associated mucous membranes (conjunctival, oral and genital), the dermis, the cutaneous vasculature and the subcutaneous tissue (subcutis).

Intended patient population​

The device is intended for use on images of skin from patients presenting visible skin structure abnormalities, across all age groups, skin types, and demographics.

Intended user​

The medical device is intended for use by healthcare providers to aid in the assessment of skin structures.

User qualification and competencies​

In this section we specificy the specific qualifications and competencies needed for users of the device, to properly use the device, provided that they already belong to their professional category. In other words, when describing the qualifications of HCPs, it is assumed that healthcare professionals (HCPs) already have the qualifications and competencies native to their profession.

Healthcare professionals​

No official qualifications are needes, but it is advisable if HCPs have some competencies:

  • Knowledge on how to take images with smartphones.
IT professionals​

IT professionals are responsible for the integration of the medical device into the healthcare organisation's system.

No specific official qualifications are needed, but it is advisable that IT professionals using the device have the following competencies:

  • Basic knowledge of FHIR
  • Understanding of the output of the device.

Use environment​

The device is intended to be used in the setting of healthcare organisations and their IT departments, which commonly are situated inside hospitals or other clinical facilities.

The device is intended to be integrated into the healthcare organisation's system by IT professionals.

Operating principle​

The device is computational medical tool leveraging computer vision algorithms to process images of the epidermis, the dermis and its appendages, among other skin structures.

Body structures​

The device is intended to use on the epidermis, its appendages (hair, hair follicle, sebaceous glands, apocrine sweat gland apparatus, eccrine sweat gland apparatus and nails) and associated mucous membranes (conjunctival, oral and genital), the dermis, the cutaneous vasculature and the subcutaneous tissue (subcutis).

In fact, the device is intended to use on visible skin structures. As such, it can only quantify clinical signs that are visible, and distribute the probabilities across ICD categories that are visible.

Variants and models​

The device does not have any variants.

Expected lifetime​

Its expected lifetime is considered unlimited because the device will be updated with each improvement opportunity extracted from the information and analysis of the data provided by the continuous and systematic post-market data follow-up.

List of any accessories​

The device does not have any accessories.

The device can be used from any device with an internet connection.

Explanation of any novel features​

The device is the result of an incremental improvement of an existing technology. It has been developed to improve the current state of the art to process photographs of skin structure and then processes them with artificial intelligence algorithms.

We detail the novel features of the devide within the Legit.Health Plus Description and specifications 2023_001 document.

Literature search methodology​

The literature search methodology establishes the strategy used to search and compile scientific articles, as well as the criteria used to include/exclude and evaluate the doctuments compiled.

Review team undertaking the literature search​

The literature search protocol has been developed and executed by professionals with expertise in information retrieval and understanding of the scope of the clinical evaluation set out by the manufacturer, who have been compensated for the time taken to perform the review.

The involvement of the literature review team will help to optimize literature retrieval to identify all relevant published literature. The review team has prepared the protocol to describe an objective, non-biased systematic search and review methods, using information found in the IFU and risk management process to develop the clinical research questions.

Period covered by the search​

The present literature search complements the last Clinical Evaluation literature search (2011 to 2020) by analyzing the work published in a 3-year period from 2021 to 2023, and further extends the above search to include the condition of facial palsy.

Goals of the literature search​

This literature search was conducted to include the relevant scientific articles that are related to:

  • Clinical trials that probe the safety and usefulness of Computer-Aided Systems for obtaining interpretative distribution representation of possible International Classification of Diseases (ICD) categories that might be represented in the pixels content of the image and quantifiable data on the intensity, count and extent of clinical signs such as erythema, desquamation, and induration, among others.
  • State-of-the-art algorithms and methods in the fields of visible conditions, specially dermatoses and facial palsy, to obtain an interpretative distribution representation of possible International Classification of Diseases (ICD) categories that might be represented in the pixels content of the image, and quantifiable data on the intensity, count and extent of clinical signs such as erythema, desquamation, and induration, among others.
  • Datasets that are useful for the development of technology to obtain an interpretative distribution representation of possible International Classification of Diseases (ICD) categories that might be represented in the pixels content of the image, and quantifiable data on the intensity, count and extent of clinical signs such as erythema, desquamation, and induration, among others, in skin structures.
  • Smartphone applications that implement or evaluate skin structures to obtain an interpretative distribution representation of possible International Classification of Diseases (ICD) categories that might be represented in the pixels content of the image, and quantifiable data on the intensity, count and extent of clinical signs such as erythema, desquamation, and induration, among others.
  • Reviews and surveys of the available literature related to obtain an interpretative distribution representation of possible International Classification of Diseases (ICD) categories that might be represented in the pixels content of the image, and quantifiable data on the intensity, count and extent of clinical signs such as erythema, desquamation, and induration, among others, in skin structures.

Data sources​

For the scientific article compilation we have used different sources of information:

Medical Literature Databases​

  • PubMed (MEDLINE): comprises more than 36 million citations for biomedical literature from MEDLINE, life science journals, and online books.
  • Cochrane Library: collection of databases that contain high-quality, independent evidence to inform healthcare decision-making. The Cochrane Library is owned by Cochrane and published by Wiley.

Google Scholar​

Google Scholar provides a simple way to broadly search for scholarly literature across a wide variety of disciplines and sources: articles, theses, books, abstracts and court opinions. Different from the Medical Literature Databases, Google Scholar also includes medical articles that have been published in non-medical journals and conferences and that might not have been indexed by the previous Medical Literature Databases.

Article Citations​

Scientific articles are also a meaningful source of information when describing their related work. Relevant articles that are cited within a given published manuscript are also considered for their evaluation.

The PICO format​

The Literature Search methodology is based on the PICO format.

This format has been designed for high-quality clinical research evidence by defining a set of relevant keywords in four different categories (Population, Intervention, Comparison, and Outcome), that are then used to construct the search queries. Since our research is not limited to clinical research, by also to articles related to state-of-the-art Deep Learning algorithms, paper reviews, and the deployment of Deep Learning solutions, we have modified these categories to also include keywords related to non-clinical terms.

Description
Population Patient Problem (P)Diseases that the software is able to identify (skin cancer, melanoma, chronic skin conditions).
Intervention (I)Intervention, prognostic factor or exposure.
Comparator (C)Known software, algorithm, or method with the same characteristics as the device.
Outcome (O)Diagnosis, identification, analysis, or assessment of certain skin pathologies.

Screening, selection, and organizing literature​

The articles retrieved from each data source go through an initial set of filters to ensure their quality and adequacy to the goals of this literature review:

Metadata check​

Duplicate articles, non-English articles, and articles published before 2021 are not considered for the Data Appraisal.

Scope analysis​

We read the abstract, motivation, and conclusions of each article to discern if they match the scope of topics pursued in the Literature Review. Articles that are our of the scope of this literature review are filtered out. After this initial look, we save a brief summary of the content and contribution of the articles.

Publication source quality analysis​

For each article, we analyze the impact factor of the journal, conference, or book where they have been published. The impact factor is a metric that reflects the ratio between the number of citations received in a year and the number of citable publications that were published in the same source during the two preceding years. In our case, we retrieve the Impact Factor from Academic Accelerator that has been calculated for the year 2021. Finally, we filter out the articles that have an Impact Factor under 3.5, which stands for a low-quality publication source. Since the Impact Factor measures the quality of the publication source and not the quality of the publication itself, we also included for the Data Appraisal the papers that we considered relevant during the Scope Analysis step.

The articles that have passed the screening quality evaluation are then forwarded to their appraisal.

Appraisal of selected literature​

The Data Appraisal evaluates the suitability of the selected articles for establishing the safety and performance of the device. To this end, we take into consideration three parameters: the methodological quality and scientific validity of the information (Q), the relevance to the device and its intended use (R), and the contribution to the overall evaluation (C). Articles are finally accepted or rejected after applying the following weight-based system. In this process, we also compile some notes related to the content and contribution of the articles.

Data characteristicsMethodological quality QRelevance, RContribution, CWeighted value, W (W=Q+R+C)Appraisal dataNotes
Very relevant information in relation to the product and its intended useUp to 40Up to 30Up to 30W ≥ 70AcceptedPivotal data
Relevant information in relation to the product and its intended useUp to 40Up to 30Up to 3030 < W < 70AcceptedOther data
Little relevant information in relation to the product and its intended useUp to 40Up to 30Up to 30W ≤ 30RejectedNo contribution, rejected

Methodological quality and scientific validity of the information (Q):

  • The scientific article properly describes the relevant related work.
  • The scientific article compares its results and conclusions with the relevant related work.
  • Clinical trials use data extracted from RCTs (Randomized Clinical Trials), meta-analysis and clinical trials, from publications based on scientific evidence or from previous experience on the market.
  • The study design is adequate in terms of type, sample size, relevance of endpoints, randomization of patients, inclusion and exclusion criteria, stratification of patients, prognostic factors, follow-up, recording and reporting of serious adverse events, reliability of the methods used for quantifying outcomes, or procedures for retrieving complete information.
  • Data consists of an adequate number of observations that can confirm or refute the claims of the device under evaluation.
  • The methods for data processing and statistics are suitable.
  • It complies with Good Clinical Practice (GCP) according to EN ISO 14155 or equivalent standards.
  • The information is disclosed adequately, including a summary, introduction, methods, results, discussion and conclusions.

Relevance to the device and its intended use (R):

  • It is representative of the device under evaluation, including data concerning the medical conditions that are managed with the device, other devices and medical alternatives, or equivalent devices.
  • The aspects covered are related to clinical safety and performance, claims, hazards and hazardous situations, management of risks, establishment of current knowledge and state of the art, determination and justification of the benefit/risk ratio and the acceptability of undesirable side-effects, or the determination of equivalence.
  • It is representative to the intended purpose or claims of the device under evaluation.
  • It is representative to the user group, patient population, medical indication, age group, gender, type and severity of the medical condition, or range of time.
  • It develops algorithms or techniques to improve the performance of skin-related image analysis.

Contribution to the overall evaluation (C):

  • Device and/or related techniques intended use. The contribution of the analyzed data in relation to the device or technique features and in relation to the intended use must be strong and clear.
  • Device and/or related techniques risk analysis. The contribution of the analyzed data in relation to the device or techniques of risk analysis must be strong and clear, based on keywords definition.

Literature Review results​

Screening​

For each one of the PICO components we have defined the set of keywords as:

CategoryKeywords
Population, Patient, Problem (P)dermatosis, skin cancer, chronic skin conditions, inflammatory skin diseases, malignant skin lesions, pigmented skin lesions, melanoma, basal cell carcinoma, squamous cell carcinoma, atypical nevus, acne, psoriasis, urticaria, atopic dermatitis, onychomycosis, melasma, solar lentigo, dermatofibroma, skin diseases, skin lesions
Intervention (I)clinical image, digital imaging, web application, smartphone, dermatoscopy, camera, CAD, dermatoscope
Comparator (C)artificial intelligence, machine learning, deep learning, computer vision, deep neural networks, convolutional neural networks, metaoptima, automated
Outcome (O)diagnosis, diagnosis support, followup, segmentation, detection, estimation, classification, assessment, severity assessment, improving

In the following, we describe how we use these keywords to form queries for each source of information, the retrieved articles, and the outcome of the Data Screening.

PubMed​

Following the PICO format and using the PubMed advanced search tool, we have defined a global query to retrieve the articles whose title or abstract relate to the query:

(("dermatosis") OR ("skin cancer") OR ("chronic skin conditions") OR ("inflammatory skin diseases") OR ("malignant skin lesions") OR ("pigmented skin lesions") OR ("melanoma") OR ("basal cell carcinoma") OR ("squamous cell carcinoma") OR ("atypical nevus") OR ("acne") OR ("psoriasis") OR ("urticaria") OR ("atopic dermatitis") OR ("onychomycosis") OR ("melasma") OR ("solar lentigo") OR ("dermatofibroma") OR ("skin diseases") OR ("skin lesions")) AND (("clinical image") OR ("digital imaging") OR ("web application") OR ("smartphone") OR ("dermatoscopy") OR ("camera") OR ("CAD")) AND (("artificial intelligence") OR ("machine learning") OR ("deep learning") OR ("computer vision") OR ("deep neural networks") OR ("convolutional neural networks") OR ("metaoptima") OR ("automated")) AND (("diagnosis") OR ("diagnosis support") OR ("followup") OR ("segmentation") OR ("detection") OR ("estimation") OR ("classification") OR ("assessment") OR ("severity assessment") OR ("improving"))

As a result, we have compiled 112 articles of which 52 articles have passed the Data Screening:

The editable table is here: https://docs.google.com/spreadsheets/d/1QrUi-Q0REVfh-X6YBD8ExUm0WsYbRoXZXyodLp_fJIo/edit?usp=sharing

IDNameJournal/ConferenceImpact factorIn scope? Not duplicated?Appraisal included
001Explainable artificial intelligence in skin cancer recognition: A systematic reviewEuropean Journal of Cancer10.002YY
002DermatoscopyClinics in dermatology2.797YN
003Legal and ethical considerations of artificial intelligence in skin cancer diagnosisThe Australasian journal of dermatology2.481NN
004DermIA: Machine Learning to Improve Skin Cancer ScreeningJournal of digital imaging4.903YY
005Artificial intelligence and melanoma: A comprehensive review of clinical, dermoscopic, and histologic applicationsPigment cell & melanoma research4.159NN
006Deep Learning for Clinical Image Analyses in Oral Squamous Cell Carcinoma: A ReviewJAMA otolaryngology-- head & neck surgery8.961NN
007Non-Melanoma Skin Cancer Detection in the Age of Advanced Technology: A ReviewCancers6.575YY
008Artificial Intelligence as a Diagnostic Tool in Non-Invasive Imaging in the Assessment of Coronary Artery DiseaseMedical sciences (Basel, Switzerland)3.642NN
009Telemedicine and e-Health in the Management of Psoriasis: Improving Patient Outcomes A Narrative ReviewPsoriasis (Auckland, N.Z.)N/AYY
010Computational Intelligence-Based Melanoma Detection and Classification Using Dermoscopic ImagesComputational intelligence and neuroscience3.120YN
011Differential Diagnosis of Rosacea Using Machine Learning and DermoscopyClinical, cosmetic and investigational dermatology2.765YN
012Evaluation of a smartphone application for diagnosis of skin diseasesPostepy dermatologii i alergologii1.664YN
013Artificial intelligence for the automated single-shot assessment of psoriasis severityJournal of the European Academy of Dermatology and Venereology : JEADV9.228YY
014A survey, review, and future trends of skin lesion segmentation and classificationComputers in biology and medicine6.698YY
015Digital skin imaging applications, part I: Assessment of image acquisition technique featuresSkin Research and Technology2.240YY
016Melanoma segmentation using deep learning with test-time augmentations and conditional random fieldsScientific reports4.997YY
017Development and Validation of a Model to Predict Posttraumatic Stress Disorder and Major Depression After a Motor Vehicle CollisionJAMA psychiatry25.936NN
018DenseNet-II: an improved deep convolutional neural network for melanoma cancer detectionSoft computing3.732YY
019Automatic skin disease diagnosis using deep learning from clinical image and patient informationSkin health and diseaseN/AYY
020An interpretable CNN-based CAD system for skin lesion diagnosisArtificial intelligence in medicine7.011YY
021A cell phone app for facial acne severity assessmentApplied intelligence (Dordrecht, Netherlands)5.019YY
022Deep learning detection of melanoma metastases in lymph nodesEuropean journal of cancer (Oxford, England : 1990)10.002NN
023Automated detection of mouse scratching behaviour using convolutional recurrent neural networkScientific reports4.997NN
024Extravasation Screening and Severity Prediction from Skin Lesion Image using Deep Neural NetworksAnnual International Conference of the IEEE Engineering in Medicine & Biology Society0.346YN
025Monitoring of Pigmented Skin Lesions Using 3D Whole Body ImagingComputer methods and programs in biomedicine7.027YY
026Computer-Aided Assessment of Melanocytic Lesions by Means of a Mitosis AlgorithmDiagnostics3.992NN
027Machine learning based skin lesion segmentation method with novel borders and hair removal techniquesPloS one3.752YY
028The role of mobile teledermoscopy in skin cancer triage and management during the COVID-19 pandemicIndian journal of dermatology, venereology and leprology2.217YN
029Medical tumor image classification based on Few-shot learningIEEE/ACM transactions on computational biology and bioinformatics3.702NN
030Convolutional neural network assistance significantly improves dermatologists' diagnosis of cutaneous tumours using clinical imagesEuropean journal of cancer (Oxford, England : 1990)10.002YY
031Skin Lesion Segmentation Using an Ensemble of Different Image Processing MethodsDiagnostics3.992YY
032Attention Cost-Sensitive Deep Learning-Based Approach for Skin Cancer Detection and ClassificationCancers6.575YY
033The Role of Pathology-Based Methods in Qualitative and Quantitative Approaches to Cancer ImmunotherapyCancers6.575NN
034ExAID: A multimodal explanation framework for computer-aided diagnosis of skin lesionsComputer methods and programs in biomedicine7.027YY
035Automatic Acne Object Detection and Acne Severity Grading Using Smartphone Images and Artificial IntelligenceDiagnostics3.992YY
036Computer-aided clinical image analysis for non-invasive assessment of tumor thickness in cutaneous melanomaBMC research notes0.527NN
037An IoMT-Based Melanoma Lesion Segmentation Using Conditional Generative Adversarial NetworksSensors3.900YY
038Smartphone-Based Hyperspectral Imaging Low-Cost Application for TelemedicineStudies in health technology and informatics0.277NN
039Human Monkeypox Classification from Skin Lesion Images with Deep Pre-trained Network using Mobile ApplicationJournal of medical systems4.920YY
040A Visually Interpretable Deep Learning Framework for Histopathological Image-Based Skin Cancer DiagnosisIEEE journal of biomedical and health informatics7.021NN
041ZooME: Efficient Melanoma Detection Using Zoom-in Attention and Metadata Embedding Deep Neural NetworkAnnual International Conference of the IEEE Engineering in Medicine & Biology Society0.346YN
042Melanoma classification from dermatoscopy images using knowledge distillation for highly imbalanced dataComputers in biology and medicine6.698YY
043Adopting low-shot deep learning for the detection of conjunctival melanoma using ocular surface imagesComputer methods and programs in biomedicine7.027NN
044A rotation meanout network with invariance for dermoscopy image classification and retrievalComputers in biology and medicine6.698YY
045Implementation of artificial intelligence algorithms for melanoma screening in a primary care settingPloS one3.752YY
046A Two-Stage Automatic Color Thresholding TechniqueSensors3.900NN
047A Deep CNN Transformer Hybrid Model for Skin Lesion Classification of Dermoscopic Images Using Focal LossDiagnostics3.992YY
048Image analysis of cutaneous melanoma histology: a systematic review and meta-analysisScientific reports4.997NN
049Application of an artificial intelligence system for endoscopic diagnosis of superficial esophageal squamous cell carcinomaWorld journal of gastroenterology5.374NN
050A deep learning based multimodal fusion model for skin lesion diagnosis using smartphone collected clinical images and metadataFrontiers in surgery2.350YN
051A novel approach toward skin cancer classification through fused deep features and neutrosophic environmentFrontiers in public health6.461YY
052Developing a Recognition System for Diagnosing Melanoma Skin Lesions Using Artificial Intelligence AlgorithmsComputational and mathematical methods in medicine2.809YN
053A machine learning-based, decision support, mobile phone application for diagnosis of common dermatological diseasesJournal of the European Academy of Dermatology and Venereology : JEADV9.228YY
054AutoRadiomics: A Framework for Reproducible Radiomics ResearchFrontiers in radiologyN/ANN
055Development and Clinical Evaluation of an Artificial Intelligence Support Tool for Improving Telemedicine Photo QualityJAMA dermatology11.816YY
056The Role of Machine Learning and Deep Learning Approaches for the Detection of Skin CancerHealthcare (Basel, Switzerland)N/AYY
057Diagnosis of Oral Squamous Cell Carcinoma Using Deep Neural Networks and Binary Particle Swarm Optimization on Histopathological Images: An AIoMT ApproachComputational intelligence and neuroscience3.120NN
058Automatic identification of benign pigmented skin lesions from clinical images using deep convolutional neural networkBMC biotechnology3.329YY
059Classification and diagnostic prediction of breast cancer metastasis on clinical data using machine learning algorithmsScientific reports4.997NN
060Reevaluation of missed lung cancer with artificial intelligenceRespiratory medicine case reports0.354NN
061Accuracy of a Smartphone-Based Artificial Intelligence Application for Classification of Melanomas, Melanocytic Nevi, and Seborrheic KeratosesDiagnostics3.992YY
062Hair removal in dermoscopy images using variational autoencodersSkin research and technology2.240YN
063Lesion identification and malignancy prediction from clinical dermatological imagesScientific reports4.997YY
064Ms RED: A novel multi-scale residual encoding and decoding network for skin lesion segmentationMedical image analysis13.828YY
065Data-Efficient Sensor Upgrade Path Using Knowledge DistillationSensors3.900NN
066Quantitative active super-resolution thermal imaging: The melanoma case studyBiomolecular concepts0.730NN
067Ensemble Method of Convolutional Neural Networks with Directed Acyclic Graph Using Dermoscopic Images: Melanoma Detection ApplicationSensors3.900YY
068Incorporating clinical knowledge with constrained classifier chain into a multimodal deep network for melanoma detectionComputers in biology and medicine6.698YY
069NDB-UFES: An oral cancer and leukoplakia dataset composed of histopathological images and patient dataData in brief0.131NN
070A Novel Approach for the Shape Characterisation of Non-Melanoma Skin Lesions Using Elliptic Fourier Analyses and Clinical ImagesJournal of clinical medicine4.964YY
071Multiclass skin lesion localization and classification using deep learning based features fusion and selection framework for smart healthcareNeural networks : the official journal of the International Neural Network SocietyN/AYY
072Light-Dermo: A Lightweight Pretrained Convolution Neural Network for the Diagnosis of Multiclass Skin LesionsDiagnostics3.992YY
073Evaluation of Computer-Aided Detection (CAD) in Screening Automated Breast Ultrasound Based on Characteristics of CAD Marks and False-Positive MarksDiagnostics3.992NN
074Homology-Based Image Processing for Automatic Classification of Histopathological Images of Lung TissueCancers6.575NN
075Multi-Task and Few-Shot Learning-Based Fully Automatic Deep Learning Platform for Mobile Diagnosis of Skin DiseasesIEEE journal of biomedical and health informatics7.021NN
076A Multi-Feature Fusion Framework for Automatic Skin Cancer DiagnosticsDiagnostics3.992YY
077Improving Skin cancer Management with ARTificial Intelligence (SMARTI): protocol for a preintervention/postintervention trial of an artificial intelligence system used as a diagnostic aid for skin cancer management in a specialist dermatology settingBMJ open3.007YN
078Computer Aided Diagnosis of Melanoma Using Deep Neural Networks and Game Theory: Application on Dermoscopic Images of Skin LesionsInternational journal of molecular sciences6.208YY
079Deeply Supervised Skin Lesions Diagnosis with Stage and Branch AttentionIEEE journal of biomedical and health informatics7.021YY
080The Role in Teledermoscopy of an Inexpensive and Easy-to-Use Smartphone Device for the Classification of Three Types of Skin Lesions Using Convolutional Neural NetworksDiagnostics3.992YY
081Validation of a Market-Approved Artificial Intelligence Mobile Health App for Skin Cancer Screening: A Prospective Multicenter Diagnostic Accuracy StudyDermatology (Basel, Switzerland)N/AYY
082Non-melanoma skin cancer diagnosis: a comparison between dermoscopic and smartphone images by unified visual and sonification deep learning algorithmsJournal of cancer research and clinical oncology4.322YY
083The Classification of Six Common Skin Diseases Based on Xiangya-Derm: Development of a Chinese Database for Artificial IntelligenceJournal of medical Internet research7.077YY
084Evaluation of Erythema Severity in Dermatoscopic Images of Canine Skin: Erythema Index Assessment and Image Sampling ReliabilitySensors3.900NN
085Performance of a deep neural network in teledermatology: a single-centre prospective diagnostic studyJournal of the European Academy of Dermatology and Venereology : JEADV9.228YY
086Comparative study on artificial intelligence systems for detecting early esophageal squamous cell carcinoma between narrow-band and white-light imagingWorld journal of gastroenterology5.374NN
087Imtidad: A Reference Architecture and a Case Study on Developing Distributed AI Services for Skin Disease Diagnosis over Cloud, Fog and EdgeSensors3.900YY
088Over-Detection of Melanoma-Suspect Lesions by a CE-Certified Smartphone App: Performance in Comparison to Dermatologists, 2D and 3D Convolutional Neural Networks in a Prospective Data Set of 1204 Pigmented Skin Lesions Involving Patients’ PerceptionCancers6.575YY
089Design and validation of a new machine-learning-based diagnostic tool for the differentiation of dermatoscopic skin cancer imagesPloS one3.752YY
090A CAD system for automatic dysplasia grading on H&E cervical whole-slide imagesScientific reports4.997NN
091Artificial intelligence-based computer-aided diagnosis system supports diagnosis of lymph node metastasis in esophageal squamous cell carcinoma: A multicenter studyHeliyon3.776NN
092Reimagining leprosy elimination with AI analysis of a combination of skin lesion images with demographic and clinical dataLancet regional health. AmericasN/AYY
093A smart LED therapy device with an automatic facial acne vulgaris diagnosis based on deep learning and internet of things applicationComputers in biology and medicine6.698YY
094Stain color translation of multi-domain OSCC histopathology images using attention gated cGANComputerized medical imaging and graphics : the official journal of the Computerized Medical Imaging Society7.422NN
095AI-based smartphone apps for risk assessment of skin cancer need more evaluation and better regulationBritish journal of cancer9.082NN
096Dermatoscopy of combined blue nevi: a multicentre study of the International Dermoscopy SocietyJournal of the European Academy of Dermatology and Venereology : JEADV9.228YY
097Bridging the digital divide among advanced age skin cancer patientsJournal of plastic, reconstructive & aesthetic surgery : JPRASN/ANN
098Melanoma: update on dermatoscopy, artificial intelligence for diagnosis, histopathology, genetics, surgery and systemic medical treatmentItalian journal of dermatology and venereologyN/ANN
099Dermatoscopy of Cutaneous Lichen Planus Attempt to Translate Metaphoric Terminology Into Descriptive TerminologyDermatology practical & conceptualN/ANN
100Experiences Regarding Use and Implementation of Artificial Intelligence-Supported Follow-Up of Atypical Moles at a Dermatological Outpatient Clinic: Qualitative StudyJMIR dermatologyN/ANN
101Applying an adaptive Otsu-based initialization algorithm to optimize active contour models for skin lesion segmentationJournal of X-ray science and technology2.442YN
102MNet-10: A robust shallow convolutional neural network model performing ablation study on medical images assessing the effectiveness of applying optimal data augmentation techniqueFrontiers in medicine4.900NN
103An attention-based weakly supervised framework for spitzoid melanocytic lesion diagnosis in whole slide imagesArtificial intelligence in medicine7.011NN
104Ex vivo fluorescent confocal microscopy images of oral mucosa: Tissue atlas and evaluation of the learning curveJournal of biophotonics3.390NN
105The dermoscopic inverse approach significantly improves the accuracy of human readers for lentigo maligna diagnosisJournal of the American Academy of Dermatology15.487NN
106Perilesional sun damage as a diagnostic clue for pigmented actinic keratosis and Bowen's diseaseJournal of the European Academy of Dermatology and Venereology : JEADV9.228NN
107The need for action by evaluators and decision makers in Europe to ensure safe use of medical softwareFrontiers in medical technologyN/ANN
108Agreement Between Experts and an Untrained Crowd for Identifying Dermoscopic Features Using a Gamified App: Reader Feasibility StudyJMIR medical informaticsN/ANN
109Assessing the Potential for Patient-led Surveillance After Treatment of Localized Melanoma (MEL-SELF): A Pilot Randomized Clinical TrialJAMA dermatology11.816NN
110Response to "Reply to 'A deep learning-based smartphone platform for cutaneous lupus erythematosus classification assistance: Simplifying the diagnosis of complicated diseases.' Has the complicated disease been simplified too much?" Artificial intelligence system is helpful for diagnosis of cutaneous lupus erythematosusJournal of the American Academy of Dermatology15.487NN
111A prospective, randomized, single-blinded, crossover trial to investigate the effect of a wearable device in addition to a daily symptom diary for the remote early detection of SARS-CoV-2 infections (COVID-RED): a structured summary of a study protocol for a randomized controlled trialTrials2.728NN
112A prospective, randomized, single-blinded, crossover trial to investigate the effect of a wearable device in addition to a daily symptom diary for the Remote Early Detection of SARS-CoV-2 infections (COVID-RED): a structured summary of a study protocol for a randomized controlled trialTrials2.728NN

Cochrane​

Following the PICO format and using the Cochrane advanced search tool, we have defined a global query to retrieve the articles whose title, abstract, or keywords relate to the query:

("dermatosis" OR "skin cancer" OR "chronic skin conditions" OR "inflammatory skin diseases" OR "malignant skin lesions" OR "pigmented skin lesions" OR "melanoma" OR "basal cell carcinoma" OR "squamous cell carcinoma" OR "atypical nevus" OR "acne" OR "psoriasis" OR "urticaria" OR "atopic dermatitis" OR "onychomycosis" OR "melasma" OR "solar lentigo" OR "dermatofibroma" OR "skin diseases" OR "skin lesions")  AND ("clinical image" OR "digital imaging" OR "web application" OR "smartphone" OR "dermatoscopy" OR "camera" OR "CAD")  AND ("artificial intelligence" OR "machine learning" OR "deep learning" OR "computer vision" OR "deep neural networks" OR "convolutional neural networks" OR "metaoptima" OR "automated") AND ("diagnosis" OR "diagnosis support" OR "followup" OR "segmentation" OR "detection" OR "estimation" OR "classification" OR "assessment" OR "severity assessment" OR "improving")

As a result, we have compiled 14 articles of which 1 articles have passed the Data Screening:

The editable table is here: https://docs.google.com/spreadsheets/d/1QrUi-Q0REVfh-X6YBD8ExUm0WsYbRoXZXyodLp_fJIo/edit?usp=sharing

IDNameJournal/ConferenceImpact factorIn scope? Not duplicated?Appraisal included
173Menopausal status, ultrasound and biomarker tests in combination for the diagnosis of ovarian cancer in symptomatic womenCochrane Database of Systematic ReviewsN/ANN
174Clinical assessment for the detection of oral cavity cancer and potentially malignant disorders in apparently healthy adultsCochrane Database of Systematic ReviewsN/ANN
175Mobile phone-based interventions for improving contraception useCochrane Database of Systematic ReviewsN/ANN
176Electronic symptom monitoring for patients with advanced cancerThe Cochrane Database of Systematic ReviewsN/ANN
177Dermoscopy Augmented Histology Trial, Consensus Agreement Diagnosis Made by Dermatopathology ExpertsNot-published yetN/ANN
178Integrated Basic Science Within the Instructional Design of Pattern Recognition TrainingNot-published yetN/ANN
179At-Home Dermoscopy Artificial Intelligence for Optimizing Early Triage of Skin CancerNot-published yetN/ANN
180AI Augmented Training for Skin SpecialistsNot-published yetN/ANN
181Assessment of deep neural networks for the diagnosis of benign and malignant skin neoplasms in comparison with dermatologists: A retrospective validation studyPLoS medicineN/ANN
182Perilesional sun damage as a diagnostic clue for pigmented actinic keratosis and Bowen's diseaseJournal of the European Academy of Dermatology and VenereologyN/ANN
183Dermoscopy Augmented Histology TrialNot-published yetN/ANN
184Development and assessment of an artificial intelligence-based tool for skin condition diagnosis by primary care physicians and nurse practitioners in teledermatology practicesJAMA network openN/AYY
185Study of AI Chromoendoscopy system for detection of early stage esophageal squamous cell carcinoma: a single-center, randomized, open-label, controlled, clinical trialsN/ANN
186Coronavirus (COVID-19): remote care through telehealthJournal of Primary Health CareN/ANN

Google Scholar​

Since the Google Scholar search tool does not allow as much detail as PubMed and Cochrane, we have defined 3 different queries to retrieve the articles. From the retrieved list of articles, sorted by relevance, we compile the first 20 results (2 pages):

Query 1: skin (lesion OR disease OR cancer) (detection OR classification)

As a result, 15 articles have passed the Data Screening:

IDNameJournal/ConferenceImpact factorIn scope? Not duplicated?Appraisal included
113Skin cancer detection: a review using deep learning techniquesInternational journal of environmental research and public health4.614YY
114A machine learning model for skin disease classification using convolution neural networkInternational Journal of Computing0.313YN
115Deep learning techniques for skin lesion analysis and melanoma cancer detection: a survey of state-of-the-artArtificial Intelligence Review9.588NN
116Skin cancer classification via convolutional neural networks: systematic review of studies involving human expertsEuropean Journal of Cancer10.002YY
117An enhanced technique of skin cancer classification using deep convolutional neural network with transfer learning modelsMachine Learning with ApplicationsN/AYY
118Multiclass skin cancer classification using EfficientNets-a first step towards preventing skin cancerNeuroscience InformaticsN/AYY
119Intelligence Skin Cancer Detection using IoT with a Fuzzy Expert SystemIn 2022 International Conference on Cyber Resilience (ICCR)N/AYY
120Machine learning and deep learning methods for skin lesion classification and diagnosis: a systematic reviewDiagnostics3.992YY
121Skin lesion classification based on deep convolutional neural networks architecturesJournal of Applied Science and Technology TrendsN/AYY
122Multi-class skin lesion detection and classification via teledermatologyIEEE journal of biomedical and health informatics7.021YY
123Monkeypox skin lesion detection using deep learning models: A feasibility studyarXivN/ANN
124Intelligent skin cancer detection applying autoencoder, MobileNetV2 and spiking neural networksChaos, Solitons & Fractals9.922YY
125Skin lesion analyser: an efficient seven-way multi-class skin cancer classification using MobileNetAdvanced Machine Learning Technologies and Applications: Proceedings of AMLTA 2020N/AYY
126Multiclass skin lesion classification using hybrid deep features selection and extreme learning machineSensors3.900YY
127Soft attention improves skin cancer classification performanceIn Interpretability of Machine Intelligence in Medical Image ComputingN/AYY
128An attention-based mechanism to combine images and metadata in deep learning models applied to skin cancer classificationIEEE journal of biomedical and health informatics7.021YY
129Uncertainty quantification in skin cancer classification using three-way decision-based Bayesian deep learningComputers in biology and medicine6.698YY
130Skin cancer detection from dermoscopic images using deep learning and fuzzy k-means clusteringMicroscopy research and technique2.893YN
131A convolutional neural network framework for accurate skin cancer detectionNeural Processing Letters2.565NN
132Single model deep learning on imbalanced small datasets for skin lesion classificationIEEE transactions on medical imaging11.037YY

Query 2: skin (lesion OR disease OR cancer) (detection OR classification) smartphone

As a result, 7 articles have passed the Data Screening:

IDNameJournal/ConferenceImpact factorIn scope? Not duplicated?Appraisal included
133Review of smartphone mobile applications for skin cancer detection: what are the changes in availability, functionality, and costs to users over time?International Journal of Dermatology3.204YN
134A smartphone based application for skin cancer classification using deep learning with clinical images and lesion informationarXivN/ANN
135Skin cancer diagnosis using convolutional neural networks for smartphone images: A comparative studyJournal of Radiation Research and Applied SciencesN/AYY
136Human monkeypox classification from skin lesion images with deep pre-trained network using mobile applicationJournal of Medical Systems4.920NN
137Accuracy of commercially available smartphone applications for the detection of melanomaThe British Journal of Dermatology11.113NN
138A smartphone-based application for an early skin disease prognosis: Towards a lean healthcare system via computer-based visionAdvanced Engineering Informatics7.862YY
139Machine learning and deep learning methods for skin lesion classification and diagnosis: a systematic reviewDiagnostics3.992NN
140New AI-algorithms on smartphones to detect skin cancer in a clinical setting—A validation studyPlos one3.752YY
141Artificial intelligence algorithm with SVM classification using dermascopic images for melanoma diagnosisJournal of Artificial Intelligence and Capsule NetworksN/AYY
142The development of skin lesion detection application in smart handheld devices using deep neural networksMultimedia Tools and Applications2.577YN
143Artificial intelligence and machine learning algorithms for early detection of skin cancer in community and primary care settings: a systematic reviewThe Lancet Digital HealthN/AYY
144Skin cancer disease images classification using deep learning solutionsMultimedia Tools and Applications2.577YN
145Over-Detection of Melanoma-Suspect Lesions by a CE-Certified Smartphone App: Performance in Comparison to Dermatologists, 2D and 3D Convolutional Neural Networks in a Prospective Data Set of 1204 Pigmented Skin Lesions Involving Patients’ PerceptionCancers6.575NN
146Artificial intelligence in the detection of skin cancerJournal of the American Academy of Dermatology.15.487YY
147Real-time skin cancer detection using neural networks on an embedded deviceBachelor's thesis, University of TwenteN/ANN
148A deep learning based multimodal fusion model for skin lesion diagnosis using smartphone collected clinical images and metadataFrontiers in Surgery2.350NN
149Smartphone-based Skin Cancer Detection using Image Processing and Convolutional Neural NetworkInternational Conference on Computing Communication and Networking Technologies (ICCCNT)N/AYY
150The role in teledermoscopy of an inexpensive and easy-to-use smartphone device for the classification of three types of skin lesions using convolutional neural networksDiagnostics3.992NN
151Automatic skin disease diagnosis using deep learning from clinical image and patient informationSkin Health and DiseaseN/ANN
152A mobile augmented reality application for supporting real-time skin lesion analysis based on deep learningJournal of Real-Time Image Processing2.293YN

Query 3: skin (lesion OR disease OR cancer) diagnosis (cnn OR convolutional OR deep learning OR artificial intelligence)

As a result, 4 articles have passed the Data Screening:

IDNameJournal/ConferenceImpact factorIn scope? Not duplicated?Appraisal included
153DSCC_Net: Multi-Classification Deep Learning Models for Diagnosing of Skin Cancer Using Dermoscopic ImagesCancers6.575YY
154Ovary cancer diagnosing empowered with machine learningInternational Conference on Business Analytics for Technology and Security (ICBATS)N/ANN
155Deep Learning-Based Classification of Dermoscopic Images for Skin LesionsSakarya University Journal of Computer and Information SciencesN/AYY
156Deep Learning-Based Cancer Detection-Recent Developments, Trend and ChallengesCMES-Computer Modeling in Engineering & Sciences2.027YN
157The classification of six common skin diseases based on Xiangya-Derm: development of a Chinese database for artificial intelligenceJournal of Medical Internet Research7.077NN
158Detection of melanoma with hybrid learning method by removing hair from dermoscopic images using image processing techniques and wavelet transformBiomedical Signal Processing and Control5.076YY
159A fully automated approach involving neuroimaging and deep learning for Parkinson’s disease detection and severity predictionPeerJ Computer Science2.411NN
160Deep learning as a new tool in the diagnosis of mycosis fungoidesArchives of Dermatological Research3.033NN
161Use of deep learning approaches in cancer diagnosisDeep Learning for Cancer DiagnosisN/ANN
162Cancer detection in breast cells using a hybrid method based on deep complex neural network and data miningJournal of Cancer Research and Clinical Oncology4.322NN
163Crccn-net: Automated framework for classification of colorectal tissue using histopathological imagesBiomedical Signal Processing and Control5.076NN
164PoxNet22: A fine-tuned model for the classification of monkeypox disease using transfer learningIEEE Access3.476YN
165MITNET: a novel dataset and a two-stage deep learning approach for mitosis recognition in whole slide images of breast cancer tissueNeural Computing and Applications5.102NN
166DermoCC-GAN: A new approach for standardizing dermatological images using generative adversarial networksComputer Methods and Programs in Biomedicine7.027YY
167Deep learning models for cancer stem cell detection: a brief reviewFrontiers in Immunology8.787NN
168RADIC: A tool for diagnosing COVID-19 from chest CT and X-ray scans using deep learning and quad-radiomicsChemometrics and Intelligent Laboratory Systems4.175NN
169Tubule-U-Net: a novel dataset and deep learning-based tubule segmentation framework in whole slide images of breast cancerScientific Reports4.997NN
170The Deep Learning Method Differentiates Patients with Bipolar Disorder from Controls with High Accuracy Using EEG DataClinical EEG and Neuroscience2.046NN
171A Novel Deep Learning-Based Approach for Segmentation of Different Type Caries Lesions on Panoramic RadiographsDiagnostics3.992NN
172Artificial intelligence in oncology: From bench to clinicSeminars in Cancer Biology (Vol. 84, pp. 113-128). Academic Press.17.012NN

Cited articles​

Two articles, cited by the article with ID 14, have passed the Data Screening:

IDNameJournal/ConferenceImpact factorIn scope? Not duplicated?Appraisal included
187A survey on deep learning for skin lesion segmentationMedical Image Analysis13.828YY
188Characteristics of publicly available skin cancer image datasets: a systematic reviewThe Lancet Digital HealthN/AYY

Data appraisal​

All the articles that passed the Data Screening have been reviewed thoroughly to assess their Quality, Relevance, and Contribution. As a result:

  • 31 articles have been evaluated as highly relevant.
  • 25 articles have been evaluated as relevant.
  • 25 articles have been evaluated as non-relevant.

The editable table is here: https://docs.google.com/spreadsheets/d/1eIGPeoYd3BqZFDWA8h6jRL36UBbsy0J6nNunvM-g12g/edit?usp=sharing

IDNameAuthorsJournal/ConferenceQ (<40)R (<30)C (<30)Weighted value
001Explainable artificial intelligence in skin cancer recognition: A systematic reviewHauser, K., Kurz, A., Haggenmueller, S., Maron, R. C., von Kalle, C., Utikal, J. S., ... & Brinker, T. J.European Journal of Cancer40201070
004DermIA: Machine Learning to Improve Skin Cancer ScreeningShoen, Ezra; Shoen, EzraJournal of digital imaging020525
007Non-Melanoma Skin Cancer Detection in the Age of Advanced Technology: A ReviewStafford, Haleigh; Buell, Jane; Yaniv, DanCancers30251570
009Telemedicine and e-Health in the Management of Psoriasis: Improving Patient Outcomes A Narrative ReviewHavelin, Alison; Hampton, Philip; Hampton, PhilipPsoriasis (Auckland, N.Z.)2520550
013Artificial intelligence for the automated single-shot assessment of psoriasis severityOkamoto, T; Kawai, M; Kawamura, TJournal of the European Academy of Dermatology and Venereology : JEADV105520
014A survey, review, and future trends of skin lesion segmentation and classificationHasan, Md Kamrul; Ahamad, Md Asif; Yang, GuangComputers in biology and medicine38271075
015Digital skin imaging applications, part I: Assessment of image acquisition technique featuresSun, Mary D; Kentley, Jonathan; Halpern, Allan CSkin Research and Technology35252585
016Melanoma segmentation using deep learning with test-time augmentations and conditional random fieldsAshraf, Hassan; Waris, Asim; Niazi, Imran KhanScientific reports35251575
018DenseNet-II: an improved deep convolutional neural network for melanoma cancer detectionGirdhar, Nancy; Sinha, Aparna; Gupta, ShivangSoft computing520025
019Automatic skin disease diagnosis using deep learning from clinical image and patient informationMuhaba, K A; Dese, K; Simegn, G LSkin health and disease35301075
020An interpretable CNN-based CAD system for skin lesion diagnosisLópez-Labraca, Javier; González-Díaz, Iván; Fueyo-Casado, AlejandroArtificial intelligence in medicine40252590
021A cell phone app for facial acne severity assessmentWang, Jiaoju; Luo, Yan; Zhang, JianglinApplied intelligence (Dordrecht, Netherlands)40282896
025Monitoring of Pigmented Skin Lesions Using 3D Whole Body ImagingAhmedt-Aristizabal, David; Nguyen, Chuong; Wang, DadongComputer methods and programs in biomedicine2051035
027Machine learning based skin lesion segmentation method with novel borders and hair removal techniquesRehman, Mohibur; Ali, Mushtaq; Mustafa Hilal, AnwerPloS one20201050
030Convolutional neural network assistance significantly improves dermatologists' diagnosis of cutaneous tumours using clinical imagesBa, Wei; Wu, Huan; Li, Cheng XEuropean journal of cancer (Oxford, England : 1990)3530873
031Skin Lesion Segmentation Using an Ensemble of Different Image Processing MethodsTamoor, Maria; Naseer, Asma; Zafar, KashifDiagnostics1515535
032Attention Cost-Sensitive Deep Learning-Based Approach for Skin Cancer Detection and ClassificationRavi, Vinayakumar; Ravi, VinayakumarCancers1510025
034ExAID: A multimodal explanation framework for computer-aided diagnosis of skin lesionsLucieri, Adriano; Bajwa, Muhammad Naseer; Ahmed, SherazComputer methods and programs in biomedicine30252075
035Automatic Acne Object Detection and Acne Severity Grading Using Smartphone Images and Artificial IntelligenceHuynh, Quan Thanh; Nguyen, Phuc Hoang; Ngo, Hoan ThanhDiagnostics15251050
037An IoMT-Based Melanoma Lesion Segmentation Using Conditional Generative Adversarial NetworksAli, Zeeshan; Naz, Sheneela; Kim, YongsungSensors15201045
039Human Monkeypox Classification from Skin Lesion Images with Deep Pre-trained Network using Mobile ApplicationSahin, Veysel Harun; Oztel, Ismail; Yolcu Oztel, GozdeJournal of medical systems515020
042Melanoma classification from dermatoscopy images using knowledge distillation for highly imbalanced dataAdepu, Anil Kumar; Sahayam, Subin; Arramraju, RashmikaComputers in biology and medicine35252585
044A rotation meanout network with invariance for dermoscopy image classification and retrievalZhang, Yilan; Xie, Fengying; Liu, JieComputers in biology and medicine25201560
045Implementation of artificial intelligence algorithms for melanoma screening in a primary care settingGiavina-Bianchi, Mara; de Sousa, Raquel Machado; Machado, Birajara SoaresPloS one35251575
047A Deep CNN Transformer Hybrid Model for Skin Lesion Classification of Dermoscopic Images Using Focal LossNie, Yali; Sommella, Paolo; Lundgren, JanDiagnostics1020535
051A novel approach toward skin cancer classification through fused deep features and neutrosophic environmentAbdelhafeez, Ahmed; Mohamed, Hoda K; Khalil, Nariman AFrontiers in public health510520
053A machine learning-based, decision support, mobile phone application for diagnosis of common dermatological diseasesPangti, R; Mathur, J; Gupta, SJournal of the European Academy of Dermatology and Venereology : JEADV35301075
055Development and Clinical Evaluation of an Artificial Intelligence Support Tool for Improving Telemedicine Photo QualityVodrahalli, Kailas; Ko, Justin; Daneshjou, RoxanaJAMA dermatology30301575
056The Role of Machine Learning and Deep Learning Approaches for the Detection of Skin CancerMazhar, Tehseen; Haq, Inayatul; Goh, Lucky Poh WahHealthcare (Basel, Switzerland)1510025
058Automatic identification of benign pigmented skin lesions from clinical images using deep convolutional neural networkDing, Hui; Zhang, Eejia; Lin, TongBMC biotechnology2025550
061Accuracy of a Smartphone-Based Artificial Intelligence Application for Classification of Melanomas, Melanocytic Nevi, and Seborrheic KeratosesLiutkus, Jokubas; Kriukas, Arturas; Valiukeviciene, SkaidraDiagnostics2520550
063Lesion identification and malignancy prediction from clinical dermatological imagesXia, Meng; Kheterpal, Meenal K; Henao, RicardoScientific reports25201055
064Ms RED: A novel multi-scale residual encoding and decoding network for skin lesion segmentationDai, Duwei; Dong, Caixia; Luo, NanaMedical image analysis35252080
067Ensemble Method of Convolutional Neural Networks with Directed Acyclic Graph Using Dermoscopic Images: Melanoma Detection ApplicationFoahom Gouabou, Arthur Cartel; Damoiseaux, Jean-Luc; Merad, DjamalSensors10101030
068Incorporating clinical knowledge with constrained classifier chain into a multimodal deep network for melanoma detectionWang, Yuheng; Cai, Jiayue; Lee, Tim KComputers in biology and medicine1510530
070A Novel Approach for the Shape Characterisation of Non-Melanoma Skin Lesions Using Elliptic Fourier Analyses and Clinical ImagesCourtenay, Lloyd A; Barbero-García, Inés; Román-Curto, ConcepciónJournal of clinical medicine105520
071Multiclass skin lesion localization and classification using deep learning based features fusion and selection framework for smart healthcareMaqsood, Sarmad; Damaševičius, Robertas; Damaševičius, RobertasNeural networks : the official journal of the International Neural Network Society55515
072Light-Dermo: A Lightweight Pretrained Convolution Neural Network for the Diagnosis of Multiclass Skin LesionsBaig, Abdul Rauf; Abbas, Qaisar; Ahmed, Alaa E SDiagnostics15151040
076A Multi-Feature Fusion Framework for Automatic Skin Cancer DiagnosticsBakheet, Samy; Alsubai, Shtwai; Alqahtani, AbdullahDiagnostics25151050
078Computer Aided Diagnosis of Melanoma Using Deep Neural Networks and Game Theory: Application on Dermoscopic Images of Skin LesionsFoahom Gouabou, Arthur Cartel; Collenne, Jules; Merad, DjamalInternational journal of molecular sciences25202065
079Deeply Supervised Skin Lesions Diagnosis with Stage and Branch AttentionDai, Wei; Liu, Rui; Liu, JunIEEE journal of biomedical and health informatics30252075
080The Role in Teledermoscopy of an Inexpensive and Easy-to-Use Smartphone Device for the Classification of Three Types of Skin Lesions Using Convolutional Neural NetworksVeronese, Federica; Branciforti, Francesco; Savoia, PaolaDiagnostics30252075
081Validation of a Market-Approved Artificial Intelligence Mobile Health App for Skin Cancer Screening: A Prospective Multicenter Diagnostic Accuracy StudySangers, Tobias; Reeder, Suzan; Wakkee, MarliesDermatology (Basel, Switzerland)35301580
082Non-melanoma skin cancer diagnosis: a comparison between dermoscopic and smartphone images by unified visual and sonification deep learning algorithmsDascalu, A; Walker, B N; David, E OJournal of cancer research and clinical oncology3010545
083The Classification of Six Common Skin Diseases Based on Xiangya-Derm: Development of a Chinese Database for Artificial IntelligenceHuang, Kai; Jiang, Zixi; Zhao, ShuangJournal of medical Internet research30302080
085Performance of a deep neural network in teledermatology: a single-centre prospective diagnostic studyMuñoz-López, C; Ramírez-Cornejo, C; Navarrete-Dechent, CJournal of the European Academy of Dermatology and Venereology : JEADV35301075
087Imtidad: A Reference Architecture and a Case Study on Developing Distributed AI Services for Skin Disease Diagnosis over Cloud, Fog and EdgeJanbi, Nourah; Mehmood, Rashid; Yigitcanlar, TanSensors40202080
088Over-Detection of Melanoma-Suspect Lesions by a CE-Certified Smartphone App: Performance in Comparison to Dermatologists, 2D and 3D Convolutional Neural Networks in a Prospective Data Set of 1204 Pigmented Skin Lesions Involving Patients’ PerceptionJahn, Anna Sophie; Navarini, Alexander Andreas; Maul, Lara ValeskaCancers155020
089Design and validation of a new machine-learning-based diagnostic tool for the differentiation of dermatoscopic skin cancer imagesTajerian, Amin; Kazemian, Mohsen; Akhavan Malayeri, AvaPloS one55515
092Reimagining leprosy elimination with AI analysis of a combination of skin lesion images with demographic and clinical dataBarbieri, Raquel R; Xu, Yixi; Moraes, Milton OLancet regional health. Americas35251575
093A smart LED therapy device with an automatic facial acne vulgaris diagnosis based on deep learning and internet of things applicationPhan, Duc Tri; Ta, Quoc Bao; Oh, JunghwanComputers in biology and medicine30102060
096Dermatoscopy of combined blue nevi: a multicentre study of the International Dermoscopy SocietyStojkovic-Filipovic, J; Tiodorovic, D; Kittler, HJournal of the European Academy of Dermatology and Venereology : JEADV30201060
113Skin cancer detection: a review using deep learning techniquesDildar, M., Akram, S., Irfan, M., Khan, H. U., Ramzan, M., Mahmood, A. R., ... & Mahnashi, M. H.International journal of environmental research and public health4020060
116Skin cancer classification via convolutional neural networks: systematic review of studies involving human expertsHaggenmüller, S., Maron, R. C., Hekler, A., Utikal, J. S., Barata, C., Barnhill, R. L., ... & Brinker, T. J.European Journal of Cancer2020545
117An enhanced technique of skin cancer classification using deep convolutional neural network with transfer learning modelsAli, M. S., Miah, M. S., Haque, J., Rahman, M. M., & Islam, M. K.Machine Learning with Applications510015
118Multiclass skin cancer classification using EfficientNets-a first step towards preventing skin cancerAli, K., Shaikh, Z. A., Khan, A. A., & Laghari, A. A.Neuroscience Informatics1010020
119Intelligence Skin Cancer Detection using IoT with a Fuzzy Expert SystemAl-Dmour, N. A., Salahat, M., Nair, H. K., Kanwal, N., Saleem, M., & Aziz, N.In 2022 International Conference on Cyber Resilience (ICCR)30151560
120Machine learning and deep learning methods for skin lesion classification and diagnosis: a systematic reviewKassem, M. A., Hosny, K. M., Damaševičius, R., & Eltoukhy, M. M.Diagnostics3520560
121Skin lesion classification based on deep convolutional neural networks architecturesSaeed, J., & Zeebaree, S.Journal of Applied Science and Technology Trends1020535
122Multi-class skin lesion detection and classification via teledermatologyKhan, M. A., Muhammad, K., Sharif, M., Akram, T., & de Albuquerque, V. H. C.IEEE journal of biomedical and health informatics20202060
124Intelligent skin cancer detection applying autoencoder, MobileNetV2 and spiking neural networksToğaçar, M., Cömert, Z., & Ergen, B.Chaos, Solitons & Fractals1010525
125Skin lesion analyser: an efficient seven-way multi-class skin cancer classification using MobileNetChaturvedi, S. S., Gupta, K., & Prasad, P. S.Advanced Machine Learning Technologies and Applications: Proceedings of AMLTA 2020510015
126Multiclass skin lesion classification using hybrid deep features selection and extreme learning machineAfza, F., Sharif, M., Khan, M. A., Tariq, U., Yong, H. S., & Cha, J.Sensors1010525
127Soft attention improves skin cancer classification performanceDatta, S. K., Shaikh, M. A., Srihari, S. N., & Gao, M.In Interpretability of Machine Intelligence in Medical Image Computing25252575
128An attention-based mechanism to combine images and metadata in deep learning models applied to skin cancer classificationPacheco, A. G., & Krohling, R. A.IEEE journal of biomedical and health informatics25252575
129Uncertainty quantification in skin cancer classification using three-way decision-based Bayesian deep learningAbdar, M., Samami, M., Mahmoodabad, S. D., Doan, T., Mazoure, B., Hashemifesharaki, R., ... & Nahavandi, S.Computers in biology and medicine35252080
132Single model deep learning on imbalanced small datasets for skin lesion classificationYao, P., Shen, S., Xu, M., Liu, P., Zhang, F., Xing, J., ... & Xu, R. X.IEEE transactions on medical imaging35303095
135Skin cancer diagnosis using convolutional neural networks for smartphone images: A comparative studyMedhat, S., Abdel-Galil, H., Aboutabl, A. E., & Saleh, H.Journal of Radiation Research and Applied Sciences55010
138A smartphone-based application for an early skin disease prognosis: Towards a lean healthcare system via computer-based visionShahin, M., Chen, F. F., Hosseinzadeh, A., Koodiani, H. K., Shahin, A., & Nafi, O. A.Advanced Engineering Informatics105520
140New AI-algorithms on smartphones to detect skin cancer in a clinical setting—A validation studyKränke, T., Tripolt-Droschl, K., Röd, L., Hofmann-Wellenhof, R., Koppitz, M., & Tripolt, M.Plos one35301075
141Artificial intelligence algorithm with SVM classification using dermascopic images for melanoma diagnosisBalasubramaniam, V.Journal of Artificial Intelligence and Capsule Networks15511
143Artificial intelligence and machine learning algorithms for early detection of skin cancer in community and primary care settings: a systematic reviewJones, O. T., Matin, R. N., van der Schaar, M., Bhayankaram, K. P., Ranmuthu, C. K. I., Islam, M. S., ... & Walter, F. M.The Lancet Digital Health35202075
146Artificial intelligence in the detection of skin cancerBeltrami, E. J., Brown, A. C., Salmon, P. J., Leffell, D. J., Ko, J. M., & Grant-Kels, J. M.Journal of the American Academy of Dermatology.3520055
149Smartphone-based Skin Cancer Detection using Image Processing and Convolutional Neural NetworkRahman, S., Raihan, M., & Mithila, S. K.International Conference on Computing Communication and Networking Technologies (ICCCNT)1010020
153DSCC_Net: Multi-Classification Deep Learning Models for Diagnosing of Skin Cancer Using Dermoscopic ImagesTahir, M., Naeem, A., Malik, H., Tanveer, J., Naqvi, R. A., & Lee, S. W.Cancers1010525
155Deep Learning-Based Classification of Dermoscopic Images for Skin LesionsSÖNMEZ, A. F., ÇAKAR, S., CEREZCİ, F., KOTAN, M., DELİBAŞOĞLU, İ., & Gülüzar, Ç. İ. T.Sakarya University Journal of Computer and Information Sciences1010525
158Detection of melanoma with hybrid learning method by removing hair from dermoscopic images using image processing techniques and wavelet transformSuiçmez, Ç., Kahraman, H. T., Suiçmez, A., Yılmaz, C., & Balcı, F.Biomedical Signal Processing and Control1010525
166DermoCC-GAN: A new approach for standardizing dermatological images using generative adversarial networksSalvi, M., Branciforti, F., Veronese, F., Zavattaro, E., Tarantino, V., Savoia, P., & Meiburger, K. M.Computer Methods and Programs in Biomedicine30201565
184Development and assessment of an artificial intelligence-based tool for skin condition diagnosis by primary care physicians and nurse practitioners in teledermatology practicesJain, A., Way, D., Gupta, V., Gao, Y., de Oliveira Marinho, G., Hartford, J., ... & Liu, Y.JAMA network open35301075
187A survey on deep learning for skin lesion segmentationMirikharaji, Z., Abhishek, K., Bissoto, A., Barata, C., Avila, S., Valle, E., ... & Hamarneh, G.Medical Image Analysis40302090
188Characteristics of publicly available skin cancer image datasets: a systematic reviewWen, D., Khan, S. M., Xu, A. J., Ibrahim, H., Smith, L., Caballero, J., ... & Matin, R. N.The Lancet Digital Health40301080

Literature Review results - Facial Palsy​

Screening​

For each one of the PICO components we have defined the set of keywords as:

Keywords
Population, Patient, Problem (P)facial palsy, facial paralysis, facial nerve palsy
Intervention (I)photo, video, expression, proportion, clinical image, smartphone, monitoring
Comparator (C)artificial intelligence, machine learning, deep learning, computer vision, deep neural networks, convolutional neural networks, regression, neural network
Outcome (O)prediction, assessment, severity assessment, improving

In the following, we describe how we use these keywords to form queries for each source of information, the retrieved articles, and the outcome of the Data Screening. Since this screening process does not contain as many articles as the previous one, we do not filter out the compiled articles with the impact factor of their publication source.

PubMed​

Following the PICO format and using the PubMed advanced search tool, we have defined a global query to retrieve the articles whose title or abstract relate to the query:

(("facial palsy") OR ("facial paralysis") OR ("facial nerve palsy")) AND ("Photo") OR ("video") OR ("expression") OR ("proportion") OR ("clinical image") OR ("smartphone") OR ("monitoring") AND ("artificial intelligence") OR ("machine learning") OR ("deep learning") OR ("computer vision") OR ("deep neural networks") OR ("convolutional neural networks") OR ("regression") OR ("neural network") AND (("prediction") OR ("assessment") OR ("severity assessment") OR ("improving"))

As a result, we have compiled 21 articles of which 20 articles have passed the Data Screening:

The editable table is here: https://docs.google.com/spreadsheets/d/1eIGPeoYd3BqZFDWA8h6jRL36UBbsy0J6nNunvM-g12g/edit?usp=sharing

IDNameJournal/ConferenceIn scope? Not duplicated?Appraisal included
001Reliability and validity of emotrics in the assessment of facial palsy.Journal of personalized medicineYY
002Artificial intelligence-driven video analysis for novel outcome measures after smile reanimation surgery.Facial plastic surgery & aesthetic medicineYY
003Toward an automatic system for computer-aided assessment in facial palsy.Facial plastic surgery & aesthetic medicineYY
004Automated spontaneity assessment after smile reanimation: a machine learning approach.Plastic and reconstructive surgeryYY
005A smartphone-based automatic diagnosis system for facial nerve palsy.Sensors (Basel, Switzerland)YY
006Machine learning models for predicting facial nerve palsy in parotid gland surgery for benign tumors.The Journal of surgical researchYY
007Clinician-graded electronic facial paralysis assessment: the eface.Plastic and reconstructive surgeryYY
008The research for the function evaluation of facial nerve and the mechanisms of rehabilitation training.MedicineNN
009Artificial neural network as a tool to predict facial nerve palsy in parotid gland surgery for benign tumors.Medical sciences (Basel, Switzerland)YY
010Prediction of long-term facial nerve outcomes with intraoperative nerve monitoring.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and NeurotologyYY
011The emerging role of artificial intelligence tools for outcome measurement in facial reanimation surgery: a review.Facial plastic surgery & aesthetic medicineYY
012A survey on computer vision for assistive medical diagnosis from faces.IEEE journal of biomedical and health informaticsYY
013Functional outcome of dual reinnervation with cross-facial nerve graft and masseteric nerve transfer for facial paralysis.Plastic and reconstructive surgeryYY
014Predicting perceived disfigurement from facial function in patients with unilateral paralysis.Plastic and reconstructive surgeryYY
015Reliability between in-person and still photograph assessment of facial function in facial paralysis using the eface facial grading system.Facial plastic surgery & aesthetic medicineYY
016Objective method of assessing and presenting the house-brackmann and regional grades of facial palsy by production of a facogram.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and NeurotologyYY
017Facial reanimation surgery restores affect display.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and NeurotologyYY
018Deepstroke: an efficient stroke screening framework for emergency rooms with multimodal adversarial deep learning.Medical image analysisYY
019In the eye of the beholder: changes in perceived emotion expression after smile reanimation.Plastic and reconstructive surgeryYY
020Quantitative analysis of facial paralysis using local binary patterns in biomedical videos.IEEE transactions on bio-medical engineeringYY
021Objective outcomes analysis following microvascular gracilis transfer for facial reanimation: a review of 10 years' experience.JAMA facial plastic surgeryYY

Cochrane​

Following the PICO format and using the Cochrane advanced search tool, we have defined a global query to retrieve the articles whose title, abstract, or keywords relate to the query:

("facial palsy" OR "facial paralysis" OR "facial nerve palsy") AND ("Photo" OR "video" OR "expression" OR "proportion" OR "clinical image" OR "smartphone" OR "monitoring") AND ("artificial intelligence" OR "machine learning" OR "deep learning" OR "computer vision" OR "deep neural networks" OR "convolutional neural networks" OR "regression" OR "neural network") AND ("prediction" OR "assessment" OR "severity assessment" OR "improving")

As a result, we have compiled 4 articles of which 0 articles have passed the Data Screening:

IDNameJournal/ConferenceIn scope? Not duplicated?Appraisal included
042Changing perception: facial reanimation surgery improves attractiveness and decreases negative facial perception.The LaryngoscopeNN
043Changing perception: facial reanimation surgery improves attractiveness and decreases negative facial perception.The LaryngoscopeNN
044A randomised controlled trial of the use of aciclovir and/or prednisolone for the early treatment of bell's palsy: the bells study.--NN
045Efficacy of nerve blocks for episodic migraine.--NN

Google Scholar​

Since the Google Scholar search tool does not allow as much detail as PubMed and Cochrane, we have defined a simplified query to retrieve the articles. From the retrieved list of articles, sorted by relevance, we compile the first 20 results (2 pages):

Query: facial (palsy OR paralysis) (prediction OR assessment OR improving) (regression OR machine learning OR computer vision OR neural network OR artificial intelligence)

As a result, 10 articles have passed the Data Screening:

IDNameJournal/ConferenceIn scope? Not duplicated?Appraisal included
022Classification of facial paralysis based on machine learning techniques.BioMedical Engineering OnLineYY
023A critical assessment and review of artificial intelligence in facial paralysis analysis: uncovering the truth.FACEYY
024Deep learning for the assessment of facial nerve palsy: opportunities and challenges.Facial Plastic SurgeryYY
025Using artificial intelligence to measure facial expression following facial reanimation surgery.Plastic and reconstructive surgeryNN
026Applications of artificial intelligence, machine learning, and deep learning on facial plastic surgeries.In Cosmetic and reconstructive facial plastic surgery: A review of medical and biomedical engineering and science concepts (pp 281-306)YY
027Advances and future directions in the care of patients with facial paralysis.Operative Techniques in Otolaryngology-Head and Neck SurgeryNN
028Toward an automatic system for computer-aided assessment in facial palsy.Facial Plastic Surgery & Aesthetic MedicineNN
029A privacy preserving diagnostic collaboration framework for facial paralysis using federated learning.Engineering Applications of Artificial IntelligenceNN
030The emerging role of artificial intelligence tools for outcome measurement in facial reanimation surgery: a review.Facial Plastic Surgery & Aesthetic MedicineNN
031Automatic facial palsy, age and gender detection using a raspberry pi.BioMedInformaticsYY
032Artificial intelligence-driven video analysis for novel outcome measures after smile reanimation surgery.Facial Plastic Surgery & Aesthetic MedicineNN
033In the eye of the beholder: changes in perceived emotion expression after smile reanimation.Plastic and Reconstructive SurgeryNN
034Automatic evaluation of facial paralysis with transfer learning and improved resnet34 neural network.In 2023 15th International Conference on Intelligent Human-Machine Systems and Cybernetics (IHMSC) (pp 218-222)YY
035Computer vision system for facial palsy detection.Journal of TechniquesYY
036Automated spontaneity assessment after smile reanimation: a machine learning approach.Plastic and Reconstructive SurgeryNN
037A narrative review of artificial intelligence (ai) for objective assessment of aesthetic endpoints in plastic surgery.Aesthetic Plastic SurgeryNN
038The auto-eface: machine learning-enhanced program yields automated facial palsy assessment tool.Plastic and Reconstructive SurgeryYY
039Artificial intelligence for automatic pain assessment: research methods and perspectives.Pain Research and ManagementNN
040Svm and logistic regression for facial palsy detection utilizing facial landmark features.In Proceedings of the 2022 Fourteenth International Conference on Contemporary Computing (pp 43-48)YY
041Smart prediction system for facial paralysis.In 2020 7th International Conference on Electrical and Electronics Engineering (ICEEE) (pp 321-327)YY

Cited articles​

One article, cited by the article with ID 026, have passed the Data Screening:

IDNameJournal/ConferenceIn scope? Not duplicated?Appraisal included
046AFLFP: A database with annotated facial landmarks for facial palsyIEEE Transactions on Computational Social SystemsYY

Data appraisal​

All the articles that passed the Data Screening have been reviewed thoroughly to assess their Quality, Relevance, and Contribution. As a result:

  • 15 articles have been evaluated as highly relevant.
  • 10 articles have been evaluated as relevant.
  • 6 articles have been evaluated as non-relevant.
IDNameAuthorsJournal/ConferenceQ (<40)R (<30)C (<30)Weighted Value
001Reliability and validity of emotrics in the assessment of facial palsy.Kim, Min Gi; Bae, Cho Rong; Kim, Dae YulJournal of personalized medicine25253080
002Artificial intelligence-driven video analysis for novel outcome measures after smile reanimation surgery.Kollar, Branislav; Schneider, Laura; Eisenhardt, Steffen UFacial plastic surgery & aesthetic medicine30202070
003Toward an automatic system for computer-aided assessment in facial palsy.Guarin, Diego L; Yunusova, Yana; Jowett, NateFacial plastic surgery & aesthetic medicine30252075
004Automated spontaneity assessment after smile reanimation: a machine learning approach.Dusseldorp, Joseph R; Guarin, Diego L; Hadlock, Tessa APlastic and reconstructive surgery1010525
005A smartphone-based automatic diagnosis system for facial nerve palsy.Kim, Hyun Seok; Kim, So Young; Park, Kwang SukSensors (Basel, Switzerland)15201045
006Machine learning models for predicting facial nerve palsy in parotid gland surgery for benign tumors.Chiesa-Estomba, Carlos Miguel; Echaniz, Oier; Graña, ManuelThe Journal of surgical research30252075
007Clinician-graded electronic facial paralysis assessment: the eface.Banks, Caroline A; Bhama, Prabhat K; Hadlock, Tessa APlastic and reconstructive surgery35302085
009Artificial neural network as a tool to predict facial nerve palsy in parotid gland surgery for benign tumors.Chiesa-Estomba, Carlos M; Sistiaga-Suarez, Jon A; Medela, AlfonsoMedical sciences (Basel, Switzerland)30252075
010Prediction of long-term facial nerve outcomes with intraoperative nerve monitoring.Isaacson, Brandon; Kileny, Paul R; El-Kashlan, Hussam KOtology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology20251055
011The emerging role of artificial intelligence tools for outcome measurement in facial reanimation surgery: a review.Fuzi, Jordan; Meller, Catherine; Dusseldorp, JosephFacial plastic surgery & aesthetic medicine40251075
012A survey on computer vision for assistive medical diagnosis from faces.Thevenot, Jerome; Lopez, Miguel Bordallo; Hadid, AbdenourIEEE journal of biomedical and health informatics35151060
013Functional outcome of dual reinnervation with cross-facial nerve graft and masseteric nerve transfer for facial paralysis.Kollar, Branislav; Weiss, Jakob B W; Eisenhardt, Steffen UPlastic and reconstructive surgery2010535
014Predicting perceived disfigurement from facial function in patients with unilateral paralysis.Lyford-Pike, Sofia; Helwig, Nathaniel E; Hadlock, Tessa APlastic and reconstructive surgery3010545
015Reliability between in-person and still photograph assessment of facial function in facial paralysis using the eface facial grading system.Malka, Ronit; Miller, Matthew; Banks, CarolineFacial plastic surgery & aesthetic medicine30202070
016Objective method of assessing and presenting the house-brackmann and regional grades of facial palsy by production of a facogram.O'Reilly, Brian F; Soraghan, John J; He, ShuOtology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology20201050
017Facial reanimation surgery restores affect display.Dey, Jacob K; Ishii, Masaru; Ishii, Lisa EOtology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology30201060
018Deepstroke: an efficient stroke screening framework for emergency rooms with multimodal adversarial deep learning.Cai, Tongan; Ni, Haomiao; Wong, Stephen T CMedical image analysis35251575
019In the eye of the beholder: changes in perceived emotion expression after smile reanimation.Dusseldorp, Joseph R; Guarin, Diego L; Hadlock, Tessa APlastic and reconstructive surgery30252075
020Quantitative analysis of facial paralysis using local binary patterns in biomedical videos.He, Shu; Soraghan, John J; Xing, DongshanIEEE transactions on bio-medical engineering35101055
021Objective outcomes analysis following microvascular gracilis transfer for facial reanimation: a review of 10 years' experience.Bhama, Prabhat K; Weinberg, Julie S; Hadlock, Tessa AJAMA facial plastic surgery30201060
022Classification of facial paralysis based on machine learning techniques.Gaber, A., Taher, M. F., Wahed, M. A., Shalaby, N. M., & Gaber, S.BioMedical Engineering OnLine25301671
023A critical assessment and review of artificial intelligence in facial paralysis analysis: uncovering the truth.Mitchell, D. T., Allen, D. Z., Greives, M. R., & Nguyen, P. D.FACE25302580
024Deep learning for the assessment of facial nerve palsy: opportunities and challenges.Boochoon, K., Mottaghi, A., Aziz, A., & Pepper, J. P.Facial Plastic Surgery35301075
026Applications of artificial intelligence, machine learning, and deep learning on facial plastic surgeries.Tokgöz, E., & Carro, M. A.In Cosmetic and reconstructive facial plastic surgery: A review of medical and biomedical engineering and science concepts (pp 281-306)3010040
031Automatic facial palsy, age and gender detection using a raspberry pi.Amsalam, A. S., Al-Naji, A., Daeef, A. Y., & Chahl, J.BioMedInformatics1051025
034Automatic evaluation of facial paralysis with transfer learning and improved resnet34 neural network.Fu, R., & Zhou, G.In 2023 15th International Conference on Intelligent Human-Machine Systems and Cybernetics (IHMSC) (pp 218-222)510520
035Computer vision system for facial palsy detection.Amsalam, A. S., Al-Naji, A., Daeef, A. Y., & Chahl, J.Journal of Techniques510520
038The auto-eface: machine learning-enhanced program yields automated facial palsy assessment tool.Miller, M. Q., Hadlock, T. A., Fortier, E., & Guarin, D. L.Plastic and Reconstructive Surgery30302080
040Svm and logistic regression for facial palsy detection utilizing facial landmark features.Arora, A., Sinha, A., Bhansali, K., Goel, R., Sharma, I., & Jayal, A.In Proceedings of the 2022 Fourteenth International Conference on Contemporary Computing (pp 43-48)155525
041Smart prediction system for facial paralysis.Ridha, A. M., Shehieb, W., Yacoub, P., Al-Balawneh, K., & Arshad, K.In 2020 7th International Conference on Electrical and Electronics Engineering (ICEEE) (pp 321-327)1451029
046AFLFP: A database with annotated facial landmarks for facial palsyXia, Y., Nduka, C., Kannan, R. Y., Pescarini, E., Berner, J. E., & Yu, H.IEEE Transactions on Computational Social Systems35203085

Responsible evaluators​

The qualifications and experience of the responsible evaluators are provided in the T-015-003 Clinical Evaluation Report (CER) to demonstrate that the responsible persons fulfill the requirements to evaluate the product clinical evaluation.

NamePositionCompanyRole in the evaluationDeclaration of interestCV
Alberto SabaterMedical Data ScientistAI Labs Group SLEditorYesYes
María Belén HirigoityDermatologist and Medical Advisor to Legit.HealthHospital 9 de Octubre and Alta Estética clinicReviewerYesYes
Constanza BalboniProfessor of Medicine (Dermatology) and Medical Advisor at Legit.HealthUBA School of MedicineReviewerYesYes
María DiezQuality Manager and PRRCAI Labs Group SLReviewerYesYes
Taig Mac CarthyDesign and development managerAI Labs Group SLReviewerYesYes
Alfonso MedelaTechnical Responsible and PRRCAI Labs Group SLApproverYesYes

Record signature meaning​

  • Author: JD-009
  • Reviewer: JD-004 or JD-003
  • Approver: JD-005
Previous
R-TF-015-001 Clinical Evaluation Plan
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R-TF-015-003 Clinical Evaluation Report
  • Scope
  • Medical device information
    • Manufacturer contact details
  • Medical device characterization
  • Intended purpose
  • Variants and models
  • Expected lifetime
  • List of any accessories
  • Explanation of any novel features
  • Literature search methodology
    • Review team undertaking the literature search
    • Period covered by the search
    • Goals of the literature search
    • Data sources
      • Medical Literature Databases
      • Google Scholar
      • Article Citations
    • The PICO format
    • Screening, selection, and organizing literature
      • Metadata check
      • Scope analysis
      • Publication source quality analysis
    • Appraisal of selected literature
  • Literature Review results
    • Screening
      • PubMed
      • Cochrane
      • Google Scholar
      • Cited articles
    • Data appraisal
  • Literature Review results - Facial Palsy
    • Screening
      • PubMed
      • Cochrane
      • Google Scholar
      • Cited articles
    • Data appraisal
  • Responsible evaluators
  • Record signature meaning
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)