ASME VVUQ 40.1-2026

This Technical Report summarizes the application of the ASME VV 40 credibility assessment framework to a computational model that simulates a mechanical test based on the ISO 14879-1 standard, which evaluates the fatigue performance of an orthopedic tibial tray component. Section 2 provides background on the credibility assessment framework and guidance on using this Technical Report. Section 3 provides a general overview of tibial tray design and evaluation, including a description of the mechanical test method. Sections 4 through 8 follow the ASME VV 40 credibility assessment framework up to Documentation and Evidence. Figure 1-1 provides the section number where each element of the ASME VV 40 credibility assessment framework is examined in this Technical Report.