Cou2

{"type":"CredibilityFactor","factorType":"Software quality assurance","requiredLevel":3,"achievedLevel":1,"rationale":"ANSYS CFX is a commercial solver with internal SQA processes, but documented evidence of SQA practices was not available to the assessment team at the level required for MRL 5. Achieved Level 1 (commercial solver assumed) vs Required Level 3 (independent SQA audit or third-party certification evidence).","acceptanceCriteria":"Software must meet minimum SQA requirements per V&V 40 Table 3 for MRL 5: documented version control, regression testing, user manual, and independent SQA audit trail.","factorStatus":"assessed","factorStandard":"ASME-VV40-2018"}

{"type":"CredibilityFactor","factorType":"Numerical code verification","requiredLevel":4,"achievedLevel":3,"rationale":"Mesh convergence study performed with GCI. No method of manufactured solutions (MMS) or independent benchmark verification against analytical solutions. Achieved Level 3 (convergence study) vs Required Level 4 (formal code verification with MMS).","acceptanceCriteria":"MRL 5 requires formal numerical code verification including MMS benchmarks, systematic convergence studies, and documented numerical error bounds for all primary quantities of interest.","factorStatus":"assessed","factorStandard":"ASME-VV40-2018"}

{"type":"CredibilityFactor","factorType":"Discretization error","requiredLevel":4,"achievedLevel":3,"rationale":"GCI computed for velocity and hemolysis on three mesh levels. Asymptotic convergence range not formally demonstrated for hemolysis metric. Achieved Level 3 (GCI computed) vs Required Level 4 (formal convergence demonstration).","acceptanceCriteria":"MRL 5 requires quantified discretization error bounds with demonstrated asymptotic convergence and formal GCI for all quantities of interest including hemolysis.","factorStatus":"assessed","factorStandard":"ASME-VV40-2018"}

{"type":"CredibilityFactor","factorType":"Test conditions","requiredLevel":4,"achievedLevel":2,"rationale":"Five flow-speed operating conditions tested, but operating envelope boundaries not systematically explored. Boundary conditions documented but experimental uncertainty on inlet/outlet conditions not fully characterized. Achieved Level 2 (representative conditions) vs Required Level 4 (systematic envelope coverage with quantified boundary condition uncertainties).","acceptanceCriteria":"MRL 5 requires test conditions that span the full intended operating envelope with documented uncertainty on all controlled parameters and systematic boundary exploration.","factorStatus":"assessed","factorStandard":"ASME-VV40-2018"}

{"type":"CredibilityFactor","factorType":"Output comparison","requiredLevel":4,"achievedLevel":2,"rationale":"Hemolysis predictions compared quantitatively against in vitro data at matched operating conditions. However, formal validation metrics with prediction intervals and systematic comparison methodology required at Level 4 were not applied. Achieved Level 2 (quantitative comparison performed) vs Required Level 4 (formal validation metrics with prediction intervals).","acceptanceCriteria":"MRL 5 requires quantitative output comparison with uncertainty bounds on both computational and experimental results, using formal validation metrics and prediction interval methodology.","factorStatus":"assessed","factorStandard":"ASME-VV40-2018"}

{"type":"CredibilityFactor","factorType":"Relevance of the quantities of interest","requiredLevel":3,"achievedLevel":2,"rationale":"Modified index of hemolysis (MIH) is a recognized surrogate for clinical hemolysis but the mapping from MIH to clinical hemolysis outcome is not fully validated. Achieved Level 2 (recognized surrogate) vs Required Level 3 (validated clinical relevance).","acceptanceCriteria":"MRL 5 requires that the quantities of interest be directly linked to clinical endpoints with documented relevance justification.","factorStatus":"assessed","factorStandard":"ASME-VV40-2018"}

{"type":"CredibilityFactor","factorType":"Relevance of the validation activities to the COU","requiredLevel":3,"achievedLevel":2,"rationale":"Validation performed on the same FDA generic pump geometry under operating conditions that match the VAD COU. However, bovine blood analog introduces species-specific hemolysis pathway uncertainty that reduces relevance for human clinical translation. Achieved Level 2 (same geometry, accepted analog) vs Required Level 3 (validated clinical relevance with human-equivalent hemolysis data).","acceptanceCriteria":"MRL 5 requires that validation activities use the same pump geometry, operating conditions, and blood analog as the intended COU application, with demonstrated relevance to human hemolysis outcomes.","factorStatus":"assessed","factorStandard":"ASME-VV40-2018"}

{"@value":"0.60","@type":"xsd:decimal"}

{"@value":"1.00","@type":"xsd:decimal"}

{"@value":"0.60","@type":"xsd:decimal"}

{"@value":"0.75","@type":"xsd:decimal"}

{"@value":"0.15","@type":"xsd:decimal"}