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. ada…