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  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, redesign and development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Predetermined Change Control Plan
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-028 AI Development
      • Specific procedures
        • T-TF-028-001 AI Description
        • T-TF-028-002 AI Development Plan
        • T-TF-028-003 Data Collection Instructions
        • T-TF-028-004 Data Annotation Instructions
        • T-TF-028-005 AI Development Report
        • T-TF-028-006 AI Release Report
        • T-TF-028-007 AI Retraining Report
        • T-TF-028-008 AI Reevaluation Report
        • T-TF-028-009 AI Design Checks
        • T-TF-028-010 AI V&V Checks
        • T-TF-028-011 AI Risk Assessment
    • 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
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
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  • Procedures
  • GP-028 AI Development
  • Specific procedures
  • T-TF-028-008 AI Reevaluation Report

T-TF-028-008 AI Reevaluation Report

Table of contents
  • Purpose
  • Scope
  • Related Documents
  • Algorithm Information
  • Modifications and Rationale
    • Description of Evaluation Changes
    • Rationale
    • Triggering Factors
  • Data Management
    • New Test Data Description
      • Data Source
      • Data Characteristics
      • Data Quality Verification
    • Comparison to Original Test Data
  • Performance Testing
    • Test Methodology
    • Original Metrics Results
    • New Metrics Results (if applicable)
    • Subgroup Analysis
  • Performance Comparison
    • Consistency Analysis
    • Gap Analysis
  • Risk Assessment
    • Risk Reevaluation
    • Impact on Risk Matrix
  • Conclusions
    • Performance Summary
    • Recommendations
  • Updated Documentation

Purpose​

Describe the purpose of this reevaluation report. Explain that an existing, unchanged algorithm is being evaluated against new test data or new performance metrics.

Scope​

Define the scope of the reevaluation, including which models are affected.

Related Documents​

Document IDTitleRelationship
R-TF-028-001AI Description
R-TF-028-002AI Development Plan
R-TF-028-005AI Development Report

Algorithm Information​

Describe the algorithm being reevaluated.

ItemValue
Algorithm Name
Version
Release Date
Original Performance

Modifications and Rationale​

Description of Evaluation Changes​

Describe the changes to the evaluation plan from the original Development Report.

Change TypeDescription
New Test Data
New Performance Metrics
Changed Requirements

Rationale​

Explain the rationale for the reevaluation.

Triggering Factors​

Describe what triggered this reevaluation (e.g., changes to product requirements, regulatory feedback, new clinical evidence).

Data Management​

New Test Data Description​

Describe any new data collection or annotation activities used for the new test set.

Data Source​

Describe the source of new test data.

Data Characteristics​

ItemValue
Total Images
Categories
Demographics

Data Quality Verification​

Describe data quality verification performed.

Comparison to Original Test Data​

Compare the new test data characteristics to the original test data.

CharacteristicOriginal Test SetNew Test Set
Size
Demographics
Sources

Performance Testing​

Test Methodology​

Describe the performance testing methodology.

Original Metrics Results​

Present results using the original metrics from the Development Report.

MetricOriginal ResultNew ResultSuccess CriterionOutcome

New Metrics Results (if applicable)​

Present results using any new metrics.

MetricResultSuccess CriterionOutcome

Subgroup Analysis​

Provide performance across relevant subgroups.

SubgroupResult

Performance Comparison​

Consistency Analysis​

Analyze whether the algorithm shows similar performance on the new testing data.

Gap Analysis​

Identify any performance gaps or differences from the original evaluation.

FindingImpactAction Required

Risk Assessment​

Risk Reevaluation​

Reevaluate any risks based on the new findings.

Impact on Risk Matrix​

Describe any updates needed to the AI Risk Matrix (R-TF-028-011).

Conclusions​

State the conclusions from the reevaluation.

Performance Summary​

Summarize whether the algorithm meets the success criteria.

Recommendations​

Provide recommendations based on the reevaluation findings.

Updated Documentation​

List any documents that need to be updated based on the reevaluation.

DocumentUpdate RequiredDescription
R-TF-028-001
R-TF-028-002
R-TF-028-011

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: JD-009
  • Reviewer: JD-009
  • Approver: JD-005
Previous
T-TF-028-007 AI Retraining Report
Next
T-TF-028-009 AI Design Checks
  • Purpose
  • Scope
  • Related Documents
  • Algorithm Information
  • Modifications and Rationale
    • Description of Evaluation Changes
    • Rationale
    • Triggering Factors
  • Data Management
    • New Test Data Description
      • Data Source
      • Data Characteristics
      • Data Quality Verification
    • Comparison to Original Test Data
  • Performance Testing
    • Test Methodology
    • Original Metrics Results
    • New Metrics Results (if applicable)
    • Subgroup Analysis
  • Performance Comparison
    • Consistency Analysis
    • Gap Analysis
  • Risk Assessment
    • Risk Reevaluation
    • Impact on Risk Matrix
  • Conclusions
    • Performance Summary
    • Recommendations
  • Updated Documentation
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.)