Quick Start Guide
Download a high-resolution version of the instructions for this simulation below.
Simulation details
ASTM F1264-16 ε1 is a standard specification and provides test methods to characterize and evaluate the design and mechanical performance of intramedullary fixation devices (IMFDs, e.g., under FDA product code HSB, 21 CFR §888.3020) designed for implantation in the medullary canal for the fixation of fractures.[1] The standard lists a battery of tests required to demonstrate that a study device is substantially equivalent to a legally marketed predicate device in a 510(k) premarket submission, which includes the ASTM F1264-16 ε1 A1 static four-point bend test. The static four-point bend test is intended to measure the bending strength and bending stiffness intrinsic to the design and material of the IMFD. Alfonso’s particle-based model of ASTM F1264-16 ε1 A1 can be used to quickly predict the likelihood that a candidate design will perform sufficiently without needing to produce and test a physical prototype.
Validation Data
To read about the validation process we use to test Alfonso’s predictions, see the links below that discuss how we compared the load displacement curves of simulated and physical static four-point bending of titanium-6 aluminum-4 vanadium extra low interstitial (Ti-6Al-4V ELI) intramedulary nail devices.
Test Report
Upon completion of your simulation, we will provide you with a link for securely downloading your results, including a Test Report as a signed PDF and PowerPoint with embedded videos, raw data in CSV format, and standalone video files in MP4 format.