Clinical trials with human subjects rarely encounter ultra-rare lethal arrhythmias during short observation windows. This paper validates ventricular fibrillation detection across a synthetic digital cohort of one million diverse cardiac profiles.
By systematically varying cardiac conduction velocities, refractory periods, and ischemic zones, the simulation exposed edge-case algorithmic misclassifications that traditional clinical trials missed.
The computational model credibility was rigorously validated against animal benchmarks, allowing the synthetic results to replace supplemental human clinical studies in an FDA 510(k) submission.