An EFS - Early Feasibility Study - would be a small number:
So sayeth the FDA
A Pivotal study for a Medical Device would be analogous to a Phase-3 drug trial. Just what size patient cohort would be required I couldn't say.
My mug's eye view would be that 500 would be the low end of a Pivotal Study.
Informed opinions about plausible sequences to commercialsation welcomed.
P
Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-33
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