Risk-informed credibility goals for finite element simulation of rib bone plates: a case study in applying ASME V&V 40 to ASTM F382 testing

Introduction While Computational Modeling and Simulation (CM&S) holds significant potential as key evidence in the design and regulatory approval process for medical devices, establishing the credibility of these results remains paramount. This study presents a case study applying the ASME V&V 40 risk-based framework to the evaluation of the four-point bending performance of rib bone plates. Methods We established two distinct Contexts of Use (COUs) for a Class III rib bone plate. COU 1 (Design Change) utilizes CM&S as stand-alone evidence for a design change (increasing the number of holes), corresponding to a High-Medium model risk. Conversely, COU 2 (Product Line Extension) employs CM&S as supplementary evidence for product line expansion (varying bending shapes), corresponding to a Medium-Medium model risk. To meet the credibility requirements commensurate with each COU, we systematically performed Numerical Code Verification (NCV), calculation verification (discretization and solver errors), sensitivity analysis, Uncertainty Quantification (UQ), and validation of the Finite Element Analysis (FEA) model using ASTM F382 bench testing. Results Verification activities confirmed numerical stability with an NCV error of 0.704%. Validation results demonstrated that the FE model agreed with experimental four-point bending results within 5% error. For key Quantities of Interest such as bending stiffness, the validation metric (|E|/Uval < 1) further supported model adequacy under the stated Context of Use. Discussion Consequently, in COU 1, where the Question of Interest (QOI) is whether increasing the hole count degrades performance, the model predicted a negligible impact (<0.2%), illustrating how CM&S may support regulatory decisions on such design changes; as this prediction was not accompanied by physical testing of the extended configurations, experimental confirmation would provide complementary evidence. In COU 2, where the QOI is whether the model can predict the performance of new pre-contoured shapes, errors within the 10% threshold established for this COU support the use of the model as supplementary evidence. This case study illustrates an approach to defining the role of CM&S based on risk and tailoring corresponding VVUQ activities to secure the credibility of data submitted for medical device regulations.