{
  "id": "https://uofa.net/morrison-v09/claim/cou2-hemolysis-adequacy",
  "type": "AssuranceClaim",
  "name": "COU2 hemolysis prediction adequacy claim",
  "description": "The CFD model can predict absolute hemolysis index values for a Class III VAD device across operating conditions with quantified uncertainty, sufficient to support device safety evaluation.",
  "wasDerivedFrom": [
    "https://uofa.net/morrison-v09/validation/hemolysis-comparison-cou2",
    "https://uofa.net/morrison-v09/validation/piv-velocity-comparison",
    "https://uofa.net/morrison-v09/validation/mesh-convergence",
    "https://uofa.net/morrison-v09/uq/monte-carlo-hemolysis-cou2"
  ],
  "acceptanceCriteria": {
    "id": "https://uofa.net/morrison-v09/criteria/cou2-acceptance",
    "type": "AcceptanceCriteria",
    "name": "COU2 VAD acceptance criteria",
    "description": "All credibility factors must meet or exceed required levels for Model Risk Level 5. Hemolysis predictions must include Monte Carlo uncertainty quantification with 95% confidence intervals. Predicted hemolysis index must fall below absolute clinical threshold (MIH < 0.1 g/100L) across all five flow-speed operating conditions."
  }
}