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  • Quality Manual
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    • GP-001 Control of documents
    • GP-002 Quality planning
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    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
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    • GP-012 Design, redesign and development
    • GP-013 Risk management
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    • GP-015 Clinical evaluation
      • Templates
        • T-015-001 Clinical Evaluation Plan_YYYY_nnn
        • T-015-003 Clinical Evaluation Report_YYYY_nnn
        • T-015-004 Clinical Investigation Plan_Study code
        • T-015-005 Investigator's Brochure_Study code_es
        • T-015-006 Clinical investigation report_Study code_en
        • T-015-006 Clinical investigation report_Study code_es
        • T-015-007 Delaration of interest Clinical evaluation team
        • T-015-008 Clinical development plan_YYYY_nnn
        • T-015-009 Clinical Investigation Plan_Study code_en
        • T-015-010 Annex E ISO 14155
        • T-015-011 State of the Art
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Non-product software validation
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Predetermined Change Control Plan
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    • GP-028 AI Development
    • GP-029 Software Delivery and Commissioning
    • GP-030 Cyber Security Management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-026 Market-specific product requirements
    • GP-110 Esquema Nacional de Seguridad
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  • GP-015 Clinical evaluation
  • Templates
  • T-015-011 State of the Art

T-015-011 State of the Art

Objectives and Scope​

Scope​

This state-of-the-art document is established in the framework of the clinical evaluation of the [DEVICE NAME] medical device (hereinafter, "the device"). Therefore, it aims to specify the clinical background and current knowledge and to establish the state of the art for the current clinical practice and medical devices used in [MEDICAL FIELD].

Objectives​

The device is intended to [DESCRIBE INTENDED PURPOSE].

Therefore, the following needs to be discussed:

  • The basics of clinical workflow in [MEDICAL FIELD].
  • Use of AI-powered medical devices in diagnostic support in clinical practice.
  • Analysis of similar devices.
  • Expected use, safety, performance, and benefits of such software.

Applicable standards and guidelines​

The clinical evaluation of the device will be performed according to the relevant legal framework and following the applicable and established standards described in the following table.

Identification of the StandardDomainCompliance informationDescription of deviationsEvidence

Literature Search​

Literature Search Plan​

Literature Search Strategy​

The bibliographic search for the state of the art was done according to the EU regulation 2017/745 requirements and following the guidelines MEDDEV 2.7/1 revision 4 June 2016. The search for relevant publications started with the definition of the criteria regarding the population of patients, the clinical indication, the specificities of the product, and the measurable outcomes.

Evaluator in charge of the searches​

The Evaluator who performed the searches on [DATE] is:

  • [NAME] - [TITLE] (CV available in Annexes).

Sources​

In the current state of the art in the corresponding medical field, the following aspects and information will be checked:

  • Applicable standards and guidance documents.
  • Information relating to the current situation in the medical field in which the device is used.
  • Benchmark devices and other devices available on the market.

Identification of relevant medical conditions/medical fields concerned​

The device is intended to [DESCRIBE INTENDED PURPOSE].

Therefore, the medical conditions identified are [DESCRIBE MEDICAL CONDITIONS].

Systematic Literature search for SOTA description​

Following section A5 of the MEDDEV 2.7/1 rev4 guide, the objective of the literature search will be conducted to complete the state of the art of the device, using the PICO methodology (Patient characteristics, type of Intervention, Control, and relevant Outcomes).

Data search question using PICO methodology​

InclusionExclusion
P (Problem/Patient/Population)
I (Intervention/indicator)
C (Comparator and type of studies)
O (Outcomes)

Generation of keywords and algorithms for bibliographic search​

DescriptionKeywords/TermsAlgorithm
P (Problem/Patient/Population)
I (Intervention/indicator)
C (Comparator and type of studies)
O (Outcomes)

Bibliographic search strategy for determining the state of the art​

Guidelines and recommendations​

The following databases have been reviewed in order to find relevant guidelines or recommendations:

DatabaseKeywords / termsFilters / limitationsRecords
Clinical Papers​
DatabaseKeywords / termsFilters / limitationsRecords

Similar devices​

Device nameManufacturer nameTargeted medical conditionsCE Marking

Results from initial queries​

#DatabaseData related toKeywords/termsFilters / limitationsRecords

Vigilance databases​

IDDatabaseKeywords/termsFilters / limitationsRecords

Registries​

Identification of registries​

[Describe registry search methodology]

Search description​

[Describe search query]

Inclusion/exclusion criteria​

[Describe criteria]

Selection of references for the review of the state of the art​

Methodology used for selection​

The selection of publications is realized in 4 steps:

  1. First selection based on the title of the article
  2. Second selection based on the abstract
  3. Third selection based on materials and methods
  4. Fourth selection based on the results of the article

At each selection step, the articles are retained or excluded based on the inclusion and exclusion criteria.

Results of the selection​

[Include PRISMA-style flowchart showing selection process]

Appraisal of clinical data for the review of the state-of-the-art​

Appraisal plan​

IDCriteriaDescriptionGrading SystemCriteriaScore

Appraisal results​

[Include appraisal results table]

State of the Art Analysis​

Clinical Background​

[Describe the clinical background for the medical field]

Current Clinical Practice​

[Describe current standard of care and clinical workflow]

Available Devices and Technologies​

[Describe existing devices and technologies in the field]

Safety and Performance Expectations​

[Describe expected safety and performance based on state of the art]

Conclusions​

[Summarize the state of the art findings and their implications for the device]

Annexes​

CVs of Evaluators​

[Include or reference CVs]

Declaration of Interests​

[Include or reference DOIs]

Record signature meaning​

  • Author: JD-004 Author name
  • Review: JD-005 Reviewer name
  • Approval: JD-001 Approver name

Template signature meaning​

info

Delete this section when you create a new record from this template.

  • Author: JD-004 María Diez
  • Review: JD-005 Alfonso Medela
  • Approval: JD-001 Andy Aguilar
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T-015-010 Annex E ISO 14155
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GP-016 Traceability and identification
  • Objectives and Scope
    • Scope
    • Objectives
    • Applicable standards and guidelines
  • Literature Search
    • Literature Search Plan
      • Literature Search Strategy
      • Evaluator in charge of the searches
      • Sources
      • Identification of relevant medical conditions/medical fields concerned
    • Systematic Literature search for SOTA description
      • Data search question using PICO methodology
      • Generation of keywords and algorithms for bibliographic search
      • Bibliographic search strategy for determining the state of the art
        • Guidelines and recommendations
        • Clinical Papers
      • Similar devices
      • Results from initial queries
      • Vigilance databases
      • Registries
        • Identification of registries
        • Search description
        • Inclusion/exclusion criteria
    • Selection of references for the review of the state of the art
      • Methodology used for selection
      • Results of the selection
    • Appraisal of clinical data for the review of the state-of-the-art
      • Appraisal plan
      • Appraisal results
  • State of the Art Analysis
    • Clinical Background
    • Current Clinical Practice
    • Available Devices and Technologies
    • Safety and Performance Expectations
  • Conclusions
  • Annexes
    • CVs of Evaluators
    • Declaration of Interests
  • Record signature meaning
  • Template 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.)