model-validation

name	model-validation
description	Designs and executes validation studies for radiology AI models to ensure clinical reliability and regulatory compliance. Use when user mentions "validate model performance", "external validation", "statistical analysis", "clinical validation", or needs model evaluation.

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

Task	Primary Metrics	Secondary
Detection	Sensitivity, Specificity, AUC	PPV, NPV, FROC
Segmentation	Dice, IoU	Hausdorff, ASD
Classification	Accuracy, AUC, F1	Sensitivity, Specificity
Regression	MAE, RMSE	Correlation, Bland-Altman

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