{
  "id": "https://uofa.net/morrison-v09/cou/cou2-vad",
  "type": "ContextOfUse",
  "name": "COU2: Ventricular assist device use (Class III)",
  "description": "A CFD model is used to predict absolute hemolysis levels across operating conditions for a centrifugal blood pump used as a ventricular assist device (VAD). Model influence is HIGH (model is primary basis for hemolysis acceptance); decision consequence is HIGH (incorrect prediction could result in chronic patient hemolysis requiring clinical intervention). Model Risk Level 5 — the highest in the Morrison assessment.",
  "intendedUse": "Use CFD to predict absolute hemolysis index values for a Class III VAD device across 5 flow-speed combinations. Results must demonstrate hemolysis below absolute clinical threshold (not relative to predicate). Requires Monte Carlo uncertainty quantification on hemolysis predictions.",
  "deviceClass": "Class III",
  "modelInfluence": "High",
  "decisionConsequence": "High"
}