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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
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    • 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
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  • Procedures
  • GP-028 AI Development
  • Specific procedures
  • T-TF-028-007 AI Retraining Report

T-TF-028-007 AI Retraining Report

Table of contents
  • Purpose
  • Scope
  • Related Documents
  • Predicate Algorithm Information
  • Modifications and Rationale
    • Description of Changes
    • Rationale
    • Change Classification
  • Data Management
    • Dataset Modifications
    • Dataset Statistics
    • Data Quality Verification
  • Training Process
    • Training Configuration
    • Training Summary
  • Performance Testing
    • Test Methodology
    • Performance Comparison
    • Non-Regression Analysis
    • Subgroup Analysis
  • Risk Assessment
    • Risk Identification
    • Risk Evaluation
    • Benefit-Risk Assessment
  • Conclusions
  • Release Information
  • Related Documents

Purpose​

Describe the purpose of this retraining report. Identify the predicate algorithm being retrained and the goals of the retraining effort.

Scope​

Define the scope of the retraining, 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
R-TF-028-006AI Release Report (Previous)

Predicate Algorithm Information​

Describe the predicate algorithm being retrained.

ItemValue
Algorithm Name
Version
Release Date
Performance

Modifications and Rationale​

Description of Changes​

Describe the specific changes made to the predicate algorithm.

Rationale​

Explain the rationale for the retraining effort.

Change Classification​

Classify the change as Minor or Major per GP-028 versioning scheme.

CriterionAssessment
Architecture Change
Training Data Modification
Hyperparameter Change
Input/Output Change

Change Classification: [Minor / Major]

Data Management​

Dataset Modifications​

Describe any modifications to the training dataset.

Modification TypeDescriptionRationale
Images Added
Images Removed
Labels Fixed

Dataset Statistics​

Before Retraining:

ItemValue
Total Images
Categories

After Retraining:

ItemValue
Total Images
Categories

Data Quality Verification​

Describe the data quality verification performed.

Training Process​

Training Configuration​

Describe any changes to the training configuration.

ParameterPredicateRetrained
Architecture
Learning Rate
Epochs
Data Augmentation

Training Summary​

Summarize the training process.

Performance Testing​

Test Methodology​

Describe the test methodology. Confirm use of the same test data and metrics as the predicate algorithm.

Performance Comparison​

Compare performance between predicate and retrained algorithms.

MetricPredicateRetrainedSuccess CriterionOutcome

Non-Regression Analysis​

Demonstrate that the retrained algorithm shows non-regression in performance.

Subgroup Analysis​

Provide performance comparison across relevant subgroups.

SubgroupPredicateRetrained

Risk Assessment​

Risk Identification​

Identify any new risks introduced by the retraining.

Risk Evaluation​

Evaluate the impact of the retraining on existing risks.

Benefit-Risk Assessment​

Provide the benefit-risk assessment for this retraining.

Conclusions​

State the conclusions from the retraining effort.

Release Information​

Reference the new AI Release Report (R-TF-028-006) if applicable.

ItemValue
New Version
Release Date

Related Documents​

Document IDTitle
R-TF-028-006
R-TF-028-010
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-028-006 AI Release Report
Next
T-TF-028-008 AI Reevaluation Report
  • Purpose
  • Scope
  • Related Documents
  • Predicate Algorithm Information
  • Modifications and Rationale
    • Description of Changes
    • Rationale
    • Change Classification
  • Data Management
    • Dataset Modifications
    • Dataset Statistics
    • Data Quality Verification
  • Training Process
    • Training Configuration
    • Training Summary
  • Performance Testing
    • Test Methodology
    • Performance Comparison
    • Non-Regression Analysis
    • Subgroup Analysis
  • Risk Assessment
    • Risk Identification
    • Risk Evaluation
    • Benefit-Risk Assessment
  • Conclusions
  • Release Information
  • Related Documents
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.)