Keywords: Quantitative output, CLSI, method comparison
Devices with quantitative output cleared through 510(k) pathway are often evaluated against a predicate to assess equivalence. In evaluations of laboratory tests with quantitative results, the CLSI document EP09-A3, provides guidance on study design and analysis for a method comparison study. There are many in vivo devices, for example optical coherence tomography (OCT) from ophthalmic devices, which are evaluated for substantial equivalence compared to a predicate device. This roundtable will discuss the potential issues for method comparison studies, study design and statistical analyses for in vivo devices with quantitative output.