AI/ML Validation Framework Skill

Purpose

The AI/ML Validation Framework Skill supports validation of AI/ML-enabled medical devices per FDA Good Machine Learning Practice (GMLP) principles, addressing data quality, model performance, and predetermined change control.

Capabilities

• Training data quality assessment
• Ground truth labeling validation
• Model performance metrics calculation (AUC, sensitivity, specificity)
• Subgroup performance analysis
• Bias and fairness evaluation
• Predetermined change control plan (PCCP) templates
• Clinical validation study design
• Locked algorithm vs. adaptive documentation
• Model explainability documentation
• Performance monitoring planning
• Real-world performance tracking