No, it's contingent on what exactly the classifier does and how independent of third party clinical judgement it is. The more hands off the clinician is, the mo

No, it's contingent on what exactly the classifier does and how independent of third party clinical judgement it is. The more hands off the clinician is, the more dangerous a false negative is, and the more time sensitive the result is, the more likely your diagnostic is going to be class 3. I would naively expect the bulk of new low risk ML product submissions to be de Novo submissions due to lack of real precedent.