Analytical procedure to simplify the minimum performance level definition in bone plate testing

All medical devices need to be tested before commercialization: for this purpose, manufacturers are used to apply test methods published as ISO or ASTM standards. ASTM F382 is the latest and most widely used test standard for metallic bone plates. The main issue in ASTM standards is the absence of acceptable levels of performance as, to date, insufficient knowledge is available to predict the consequences of using an osteosynthesis device in individual patients in the first few days after surgery. The main purpose of this work is to develop an analytical procedure to determine the minimum level of performance of a generic bone plate and simplify the experimental tests campaign for regulatory purposes.