Lol ... AICp - no more nonsense - p4 - section on statistical considerations - "Based on data generated in previous studies [27], we estimate the PPA and NPA of the ResAppDx algorithm to be 85% and 80%, respectively."
Just ask them.
Ann: Pre-Submission package lodged with the US FDA, page-31
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #