DecisionRecord
Cou2 overall
https://uofa.net/morrison-v09/decision/cou2-overall
Described in
packs/vv40/examples/morrison-v09/cou2/uofa-morrison-v09-cou2.jsonld
Fields
@type |
DecisionRecord |
uofa:role |
Credibility assessment team |
uofa:outcome |
Not accepted |
uofa: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. |
uofa:decidedAt |
2019-02-01T00:00:00Z |
uofa:decisionProvenance |
extracted |
uofa:decisionAnchor |
{"type":"SourceAnchor","anchorLocator":"archive://morrison/source/decision_rationale_cou2.pdf","anchorSha256":"sha256:e64fc31cc0ccbb4e88c6bbed65d4ae2d24e7f8f25c428dda62607bed5fd6f4a9"} |
References
uofa:actor |
https://uofa.net/org/FDA-CDRH |
Referenced by
Which records point at this identifier, and through which property. This relationship is not written down anywhere in the packages themselves; it is derived by indexing the whole corpus.
| Record | Property | Source |
|---|---|---|
https://uofa.net/morrison-v09/cou2 |
uofa:hasDecisionRecord |
uofa-morrison-v09-cou2.jsonld |