Model Validation

Model Validation Skill

Triggers

• "validate model performance"
• "external validation"
• "statistical analysis"
• "clinical validation"
• "model comparison"
• "regulatory submission"
• "performance benchmarking"
• "fairness audit"

Parameters

• validation_type (required): Type of validation needed
  • internal - Retrospective internal dataset
  • external - Prospective/out-of-distribution testing
  • prospective - Clinical deployment study
  • regulatory - FDA/EMA submission prep
  • fairness - Subgroup disparity analysis
  • comparison - Head-to-head model comparison
• model_task (required): Model's intended use
  • detection - Sensitivity, specificity, PPV, NPV
  • segmentation - Dice, IoU, Hausdorff distance
  • classification - Accuracy, AUC, F1 score
  • regression - MAE, RMSE, correlation
• modality (optional): Imaging modality
• regulatory_path (optional): Target clearance pathway

Validation Framework

Performance Metrics

Statistical Methods

• Confidence intervals (bootstrap, binominal)
• Significance testing (McNemar, DeLong for AUC)
• Power analysis for sample sizing
• Multiple comparison correction
• Subgroup interaction testing

Regulatory Standards

• FDA 510(k) predicate comparison
• FDA De Novo requirements
• EU MDR clinical evaluation
• IMDRF clinical evidence framework
• ACR-SIIM AI performance standards

Output Format

Returns structured JSON with:

• Validation protocol and methodology
• Required sample size with power analysis
• Statistical test selection and rationale
• Results template with standard metrics
• Interpretation guidelines
• Regulatory compliance checklist

Usage Examples

validation_type: external
model_task: detection
modality: CT

validation_type: regulatory
model_task: classification
regulatory_path: 510k