Abstract Computational modeling and simulation (CM&S) is increasingly used to complement or replace traditional bench testing in the design, evaluation, and regulatory assessment of orthopedic devices. For orthopedic bone screws, pullout performance is commonly assessed through ASTM F543 testing, but this process can be costly and time-consuming. Finite element (FE) models, when subjected to rigorous verification, validation, and uncertainty quantification, can serve as surrogates to reduce reliance on experimental testing while supporting regulatory submissions. This study presents an end-to-end methodology for establishing the credibility of a device-agnostic FE model simulating screw pullout in accordance with ASTM F543. The model replicates the mechanical interaction between a bone screw and synthetic bone foam, with the quantity of interest being the maximum pullout force. Its context of use is defined as a full surrogate for physical testing, and its associated use risk was determined to be Medium-High, based on its role in device safety and performance assessment. Credibility activities were defined using the ASME V&V 40 framework and the 2023 FDA CM&S credibility guidance. Twenty-five credibility factors were reviewed, and High ratings were achieved for 20, reflecting a high degree of rigor across verification, calibration, validation, and applicability evidence. Through this structured process, this work illustrates how a risk-informed credibility framework can be applied to establish a validated computational model of a standardized test in the medical device field, supporting its use as a surrogate for bench testing in both development and regulatory contexts.
Benoit et al. (Wed,) studied this question.