A Benchtop Model for Comparison of Abrasiveness between Surgical Devices

摘要

Initial testing has shown feasibility of the method and provided data with statistically significant differences between groups. Going forward, additional samples may be evaluated to increase sample size and measurements such as depth and length may be analyzed. Although this model cannot be used to directly evaluate safety, as there is patient interaction or healing response; the method produced objective data that allowed for direct and objective comparisons between groups. This provides a new tool to evaluate abrasion for use throughout new product development, from benchmarking the performance of predicate products with known clinical safety profiles to comparison of new product concepts and various design iterations. In the future this method may be adapted to model the interaction between other devices and surrounding tissue in their respective applications. In this way, the method described herein may provide an additional tool in new product development across various specialties and applications.