62 - "Credibility Assessment of the FDA's MDDT-qualified 'Endpoint - numaScrew Virtual Pullout Test' model"
This webinar will outline the end-to-end process of achieving formal qualification of a computational model and simulation (CM&S) tool through the FDA's Medical Device Development Tools (MDDT) program. Specifically, it will detail the methodology used to establish the credibility of "Endpoint - numaScrew Virtual Pullout Test" model, which is designed to replicate screw pullout behavior in synthetic bone foam, consistent with ASTM F543-A3.
Credibility activities were defined and executed based on both the ASME V&V40-2018 standard and the recent FDA guidance on CM&S credibility assessment. Its context of use is defined as a full surrogate for physical testing, and its associated model risk was determined to be Medium-High based on its role in the device safety and performance assessment. A total of 25 credibility factors were assessed across verification, calibration, validation, and applicability activities. A high credibility rating was obtained for 19 of the 25 credibility factors and a medium credibility rating was obtained for the remaining 6 credibility factors. The overall credibility level of the model was assessed to be Medium-High, commensurate with the model's risk.
This webinar may be one of the first presenting an end-to-end example of the application of the FDA guidance on CM&S credibility assessment.
