T-015-006 Clinical investigation report_Study code_en
Introduction
Title of clinical investigation
Description
If it is not clearly evident from the title itself, provide a single sentence describing the study design, comparison, duration, method of use, and the subject population.
Identification of the investigational device
| Information | |
|---|---|
| Device name | Legit.Health Plus (hereinafter, the device) |
| Model and type | NA |
| Version | 1.0.0.0 |
| Basic UDI-DI | 8437025550LegitCADx6X |
| Certificate number (if available) | MDR 792790 |
| EMDN code(s) | Z12040192 (General medicine diagnosis and monitoring instruments - Medical device software) |
| GMDN code | 65975 |
| Class | Class IIb |
| Classification rule | Rule 11 |
| Novel product (True/False) | FALSE |
| Novel related clinical procedure (True/False) | FALSE |
| SRN | ES-MF-000025345 |
Details of the sponsor
| Manufacturer data | |
|---|---|
| Legal manufacturer name | AI Labs Group S.L. |
| Address | Street Gran Vía 1, BAT Tower, 48001, Bilbao, Bizkaia (Spain) |
| SRN | ES-MF-000025345 |
| Person responsible for regulatory compliance | Alfonso Medela, María Diez, Giulia Foglia |
| office@legit.health | |
| Phone | +34 638127476 |
| Trademark | Legit.Health |
Identification of the Clinical Investigation Plan (CIP)
Publicly accessible database registration number
Details about coordinating investigators, principal investigators and any other relevant parties
Compliance statement
The clinical investigation was perforfed according to the Clinical Investigation Plan (CIP) and other applicable guidances and regulations. This includes compliance with:
- Harmonized standard
UNE-EN ISO 14155:2021 Regulation (EU) 2017/745 on medical devices (MDR)- Harmonized standard
UNE-EN ISO 13485:2016s Regulation (EU) 2016/679(GDPR).- Spanish
Organic Law 3/2018on the Protection of Personal Data and guarantee of digital rights`.
All data processing within the device is carried out in accordance with the highest standards of data protection and privacy. Patient information is managed in an encrypted manner to ensure confidentiality and security.
The research team assumes the role of Data Controller, responsible for the collection and management of study data. Legit.Health acts as the Data Processor and is not involved in the processing of patient data.
The storage and transfer of data comply with European data protection regulations. At the conclusion of the study, all information stored in the device will be permanently and securely deleted.
The device employs robust technical and organizational security measures to safeguard personal data against unauthorized access, alteration, loss, or processing.
Date and author of the report
Author(s) of the report
Insert full name and job description.
Date of the report
Insert date in YYYY-MM-DD format.
Table of contents
Table of contents
- Introduction
- Title of clinical investigation
- Description
- Identification of the investigational device
- Details of the sponsor
- Identification of the Clinical Investigation Plan (CIP)
- Publicly accessible database registration number
- Details about coordinating investigators, principal investigators and any other relevant parties
- Compliance statement
- Date and author of the report
- Table of contents
- Summary
- Abbreviations and definitions
- Introduction
- Investigational device and methods
- Results
- Discussion and overall conclusions
- Ethical aspects
- Investigators and administrative structure of clinical investigation
- Signature Page
- Report Annexes
Summary
Title of the clinical investigation
Purpose of the clinical investigation
Description of the investigational device
This section contains a short summary of the device. A complete description of the intended purpose, including device description, can be found in the record Legit.Health Plus description and specifications.
Product description
The device is 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 purpose
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.
Intended previous uses
No specific intended use was designated in prior stages of development.
Product changes during clinical research
The device maintained a consistent performance and features throughout the entire clinical research process. No alterations or modifications were made during this period.
Description of the clinical investigation
Description of the clinical investigation population
Study design
Objectives and endpoints
Sample size
Description of the clinical investigation methods
Results of the clinical investigation
Conclusion of the clinical investigation
Dates of the clinical investigation
Provide the date of the clinical investigation initiation and the date of completion. Provide details about early termination, temporary halts or suspensions, if applicable.
Abbreviations and definitions
- CAD: Computer-Aided Diagnosis
- CIP: Clinical Investigation Plan
- CUS: Clinical Utility Questionnaire
- SUS: System Usability Scale
- GCP: Standards of Good Clinical Practice
- ICH: International Conference of Harmonization
- PI: Principal Investigator
- DLQI: Dermatology Quality of Life Index
- ICH: International Conference of Harmonization
- AUC: Area Under the ROC Curve
Introduction
The introduction should contain a brief statement placing the clinical investigation in the context of the development of the investigational device and relating the critical features of clinical investigation (e.g., objectives and hypotheses, target population, treatment, and follow-up duration) to that development.
Any guidelines followed in the development of the CIP (Clinical Investigation Plan) or any other agreements/meetings between the promoter and regulatory authorities relevant to the specific clinical research should be identified or described.
Investigational device and methods
Investigational device description
This section contains a short summary of the device. A complete description of the intended purpose, including device description, can be found in the record Legit.Health Plus description and specifications.
Product description
The device is 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 purpose
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.
Intended previous uses
No specific intended use was designated in prior stages of development.
Product changes during clinical research
The device maintained a consistent performance and features throughout the entire clinical research process. No alterations or modifications were made during this period.
Clinical investigation plan
Provide a summary of the CIP (Clinical Investigation Plan), including any subsequent modifications with justification for each modification. The summary should include a brief description of the points indicated below.
Objectives
Design
Provide details about the type of clinical investigation, clinical investigation endpoints.
Ethical considerations
The conduct of this study adhered to international Good Clinical Practice (GCP) guidelines, the Declaration of Helsinki in its latest amendment, and applicable international and national regulations. Approval from the relevant Ethics Committee was obtained prior to the initiation of the study. Any modifications to the protocol were reviewed and approved by the Principal Investigator (PI) and subsequently evaluated by the Ethics Committee before subjects were enrolled under a modified protocol.
This study was conducted in compliance with European Regulation 2016/679, of 27 April, concerning the protection of natural persons with regard to the processing of personal data and the free movement of such data (General Data Protection Regulation, GDPR), and Organic Law 3/2018, of 5 December, on the Protection of Personal Data and the guarantee of digital rights. In accordance with these regulations, no data enabling the personal identification of participants was collected, and all information was managed securely in an encrypted format.
Patients were informed both orally and in writing about all relevant aspects of the study, with the information being tailored to their level of understanding. They were provided with a copy of the informed consent form and the accompanying patient information sheet. Adequate time was given to patients to ask questions and fully comprehend the details of the study before providing their consent.
The Principal Investigator was responsible for the preparation of the informed consent form, ensuring it included all elements required by the International Conference on Harmonisation (ICH), adhered to current regulatory guidelines, and complied with the ethical principles of GCP and the Declaration of Helsinki.
The original signed informed consent forms were securely stored in a restricted access area under the custody of the PI. These documents remained at the research site at all times. Patients were provided with a copy of their signed consent form for their records.
Data quality assurance
The Principal Investigator is responsible for reviewing and approving the protocol, signing the Principal Investigator commitment, guaranteeing that the persons involved in the centre will respect the confidentiality of patient information and protect personal data, and reviewing and approving the final study report together with the sponsor. All the clinical members of the research team assess the eligibility of the patients in the study, inform and request written informed consent, collect the source data of the study in the clinical record and transfer them to the Data Collection Notebook (DCN) or Data Collection Forms (CRF).
Subject population
Inclusion and exclusion criteria
Sample size
Follow-Up duration
Statistical analysis
Include hypotheses or success/failure criteria, sample size calculation, statistical analysis methods, and interim analyses, where applicable.
Results
Initiation and completion date
The initiation and completion/suspension date of the clinical investigation.
Subject and investigational product management
Management of subjects (number screened, randomized, and received therapy) and disposition of investigational products.
Subject demographics
Compliance with Clinical Investigation Plan (CIP)
Analysis of results
There should be a clear distinction between primary analyses, other pre-specified analyses, and additional analyses.
Clinical performance, effectiveness and safety results performance
An analysis of performance and results based on the evaluation criteria specified in the CIP (Clinical Investigation Plan).
Adverse events and adverse device effects
A summary of all adverse events and adverse device effects, including a discussion of the severity of the event, necessary treatment, resolution, and the relevant principal investigator's judgement concerning the causal relationship with the investigational products or procedures.
Device deficiencies
A table summarizing all observed device deficiencies that could have led to a serious adverse device effect and any corrective actions taken during the clinical investigation, if any.
Subgroup analysis for special populations
Any subgroup analysis required for special populations (e.g., sex, racial/cultural/ethnic subgroups), as applicable.
Accounting for all subjects
Description of how missing data or deviations in the analysis were handled, including subjects who did not pass screening, were lost to follow-up, withdrew, or had their participation terminated prematurely and the reasons for such.
Discussion and overall conclusions
Clinical performance, effectiveness, and safety
Results of safety and performance and any other endpoints.
Clinical risks and benefits assessment
Clinical relevance
A discussion of the clinical relevance and importance of the results in light of other existing data and the state of the art.
Specific benefit or special precaution
Implications for future clinical investigation
Limitations of the clinical investigation
Any limitations of clinical investigation (subject selection, retention, and compliance; selection, retentionm adherence to CIP of investigation sites and users; bias introduced by missing observations, by subjects and by investigators).
Ethical aspects
This section should include:
- Confirmation that the EC reviewed the CIP (Clinical Investigation Plan) and any amendments (if required).
- List of all consulted ECs.
- Confirmation that the clinical investigation was conducted in accordance with the ethical principles of the Declaration of Helsinki.
- A statement that informed consent was obtained and when it was obtained.
Investigators and administrative structure of clinical investigation
Brief description of the clinical investigation organisation
Investigators
A list of investigators, including their institutional affiliation.
External organization
The names and addresses of any third parties (such as central laboratories, CROs, consultants, and other contractors) who contributed to clinical research.
Contact details of the sponsor
Signature Page
Signatures of the promoter and the coordinating investigator(s) indicating their agreement with the content of the clinical research report. If no coordinating investigator has been appointed, the signatures of the principal investigators should be obtained. Signature pages can be included separately from the clinical research report itself.
Report Annexes
Annexes to the report may contain the following information:
- The CIP, including amendments.
- Instructions for use.
- A list of principal investigators and the research centers to which they are affiliated, including a summary of their qualifications or a copy of their CVs.
- A list of collaborating investigators and the research centers to which they are affiliated, including a summary of their qualifications or a copy of their CVs.
- A list of the names and addresses of any third parties (such as central laboratories, CROs, consultants, and other contractors) who contributed to clinical research.
- A list of monitors.
- A list of ECs.
- Tabulation of all relevant datasets, including:
- Deviations from the CIP that affected subject rights, safety, or welfare, or the scientific integrity of clinical research.
- All adverse events, adverse reactions to the product, and product deficiencies.
- Withdrawals and suspensions.
- The audit certificate, if applicable.
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003, JD-004
- Approver: JD-001
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- Author: JD-004
- Review: JD-003
- Approval: JD-005