Unit of Assurance

UnitOfAssurance

Cou1

https://uofa.net/nagaraja/cou1

Described in packs/vv40/examples/nagaraja/cou1/uofa-nagaraja-cou1.jsonld

Fields

@type UnitOfAssurance
uofa:conformsToProfile https://uofa.net/vocab#ProfileComplete
schema:name Nagaraja COU1 — Non-cannulated pedicle screw compression-bending credibility assessment
schema:description V&V 40 credibility assessment for FEA prediction of ASTM F1717 static compression-bending performance of a non-cannulated 7.5 mm pedicle screw construct. COU1 is the validation activity itself — the FEA model ensemble (FDA, Ansys, DePuy Synthes) is compared against N=11 experimental constructs across two laboratories. All 13 V&V 40 factors assessed; one factor (Test conditions) below required level due to single test condition.
prov:wasDerivedFrom https://doi.org/10.1016/j.ymeth.2024.03.003
prov:generatedAtTime 2024-03-08T00:00:00Z
uofa:hash sha256:c0c3c30b766833b5581cea440871dfeae07e4745dbd6d55fd47797fff27e2727
uofa:signature ed25519:6492cb6e175eba273a22cd3a5f905c8932b93686fe3aa61ce092aa3cf95443c834f694c0f5e54f57aae6149d13615e383bf06a09839f6d9f075307074e7e7e04
uofa:signatureAlg ed25519
uofa:canonicalizationAlg json-sortkeys/v1
uofa:assuranceLevel Medium
uofa:credibilityIndex
{"@value":"0.92","@type":"xsd:decimal"}
uofa:traceCompleteness
{"@value":"0.92","@type":"xsd:decimal"}
uofa:verificationCoverage
{"@value":"1.00","@type":"xsd:decimal"}
uofa:validationCoverage
{"@value":"1.00","@type":"xsd:decimal"}
uofa:uncertaintyCIWidth
{"@value":"0.037","@type":"xsd:decimal"}
uofa:modelRiskLevel 3
uofa:deviceClass Class II
uofa:couName Non-cannulated F1717 compression-bending
uofa:decision Accepted
uofa:hasUncertaintyQuantification true
uofa:hasSensitivityAnalysis true

References

uofa:bindsRequirement https://uofa.net/nagaraja/req/mechanical-integrity
uofa:bindsClaim https://uofa.net/nagaraja/claim/cou1-noncannulated-adequacy
uofa:bindsModel https://uofa.net/nagaraja/model/ansys-abaqus-ensemble
uofa:bindsDataset https://uofa.net/nagaraja/data/f1717-bench
uofa:bindsDataset https://uofa.net/nagaraja/data/e8-ti6al4v
uofa:hasContextOfUse https://uofa.net/nagaraja/cou/cou1-noncannulated
uofa:hasValidationResult https://uofa.net/nagaraja/validation/mesh-convergence
uofa:hasValidationResult https://uofa.net/nagaraja/validation/numerical-solver-error
uofa:hasValidationResult https://uofa.net/nagaraja/validation/level1-qoi-comparison
uofa:hasValidationResult https://uofa.net/nagaraja/validation/level2-asme-vv20-comparison
uofa:hasValidationResult https://uofa.net/nagaraja/validation/sensitivity-analysis
uofa:hasValidationResult https://uofa.net/nagaraja/validation/monte-carlo-uq
prov:wasAttributedTo https://uofa.net/org/nagaraja-grau-inc
uofa:hasCredibilityFactor https://uofa.net/nagaraja/cou1/factor/software-quality-assurance
uofa:hasCredibilityFactor https://uofa.net/nagaraja/cou1/factor/numerical-code-verification
uofa:hasCredibilityFactor https://uofa.net/nagaraja/cou1/factor/discretization-error
uofa:hasCredibilityFactor https://uofa.net/nagaraja/cou1/factor/numerical-solver-error
uofa:hasCredibilityFactor https://uofa.net/nagaraja/cou1/factor/use-error
uofa:hasCredibilityFactor https://uofa.net/nagaraja/cou1/factor/model-form
uofa:hasCredibilityFactor https://uofa.net/nagaraja/cou1/factor/model-inputs
uofa:hasCredibilityFactor https://uofa.net/nagaraja/cou1/factor/test-samples
uofa:hasCredibilityFactor https://uofa.net/nagaraja/cou1/factor/test-conditions
uofa:hasCredibilityFactor https://uofa.net/nagaraja/cou1/factor/equivalency-of-input-parameters
uofa:hasCredibilityFactor https://uofa.net/nagaraja/cou1/factor/output-comparison
uofa:hasCredibilityFactor https://uofa.net/nagaraja/cou1/factor/relevance-of-the-quantities-of-interest
uofa:hasCredibilityFactor https://uofa.net/nagaraja/cou1/factor/relevance-of-the-validation-activities-to-the-cou
uofa:hasDecisionRecord https://uofa.net/nagaraja/decision/cou1-overall
uofa:criteriaSet https://uofa.net/criteria/ASME-VV40-2018

Integrity

This identifier names a signed package. Verify it yourself against the record in the repository.

uofa check --build packs/vv40/examples/nagaraja/cou1/uofa-nagaraja-cou1.jsonld