U.S. Food and Drug Administration

This regulatory science tool is a software tool that computes select controller response metrics relevant to physiologic closed-loop controlled (PCLC) medical devices. The tool accepts response data of a controlled physiologic variable collected from any testing modality, including in vivo animal studies, clinical studies, bench testing, or computational simulation, and calculates a set of closed-loop controller response metrics, including median performance error, median absolute performance error, wobble, percentage of time within target range, rise time, percentage overshoot, settling time, divergence, and steady state error.

A tool to assist with evaluating and quantifying contractile response of non-excitatory electrical stimulation signals including CCM in vitro using 2D human cardiomyocyte models