HI, @Scott, I haven’t done any protocols for medical devices but in the past working in clinical settings, we have planned different protocols, proposals. We mostly used Gpower analysis to determine the amount of subjects (samples) needed for a protocol (power around 80%) in order for the data to be reliable. And with the confidence level, we used 95%.
Did you use Gpower for your protocol? if you did, what’s good/typical power to go by?