{
  "id": "https://uofa.net/morrison/cou/cou1-cpb",
  "type": "ContextOfUse",
  "name": "COU1: Cardiopulmonary bypass use (Class II)",
  "description": "A CFD model is used to evaluate the sensitivity of pump-induced hemolysis to variations in component dimensions for a centrifugal blood pump used during cardiopulmonary bypass surgery. Model influence is MEDIUM (testing confirms results); decision consequence is HIGH (incorrect tolerance decision could impact clinical hemolysis levels). Model Risk Level 2.",
  "intendedUse": "Use CFD to identify worst-case operating conditions for hemolysis across 5 flow-speed combinations for a Class II CPB device. Results compared against predicate device hemolysis using relative hemolysis index (RH < 1 acceptance criterion).",
  "deviceClass": "Class II",
  "modelInfluence": "Medium",
  "decisionConsequence": "High"
}