A "threshold-based" approach to determining an acceptance criterion for model validation

A “credible” computational model has the potential to provide a meaningful evaluation of safety in medical-device submissions. The ASME V&V 40 standard lists and discusses various credibility assessment factors that are essential to support model credibility.However, this standard does not provide a mechanism to determine if/when the difference between the computational model and experimental results can be deemed acceptable. This is a key step in the credibility assessment process for computational models.This tool, a “threshold-based” validation method, provides a way to determine a well-defined acceptance criterion for comparison error (which is the difference between the simulation results and validation experiments.) The threshold approach for establishing validation criteria is applicable for situations where threshold values for safety/performance are available for the quantity of interest.An example demonstration of this method is provided here.