That is a very good point that doesn't get mentioned enough..."you only need to prove efficacy if a similar device already existed". Doesn't this apply to all surgical devices? How hard can it be to prove efficacy in something that is being done every day with another robot?
I've seen a two balloon Kyphoplasty system be defeated on patent early with a uni-pedicular better system, packaging differences and 510K granted swiftly on predicate device of the aforementioned system.
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