{
  "id": "https://uofa.net/morrison/decision/cou2-overall",
  "type": "DecisionRecord",
  "actor": "https://uofa.net/org/FDA-CDRH",
  "role": "Credibility assessment team",
  "outcome": "Not accepted",
  "rationale": "Model not deemed sufficiently credible for COU2. All seven assessed credibility factors have achieved levels below the required levels for Model Risk Level 5. Key gaps: software quality assurance (achieved 1 vs required 3), numerical code verification (achieved 3 vs required 4), discretization error (achieved 3 vs required 4), test conditions (achieved 2 vs required 4), output comparison (achieved 2 vs required 4), relevance of quantities of interest (achieved 2 vs required 3), and relevance of validation activities to the COU (achieved 2 vs required 3). Additionally, 6 of 13 credibility factors were not assessed, representing epistemic gaps at MRL 5. The evidence shows the model does not meet the credibility bar for a Class III VAD application. Additional verification and validation activities required before the model can support Class III VAD hemolysis claims.",
  "decidedAt": "2019-02-01T00:00:00Z"
}