Not necessarily to the former. Definitely to the latter.<p>To elaborate point 1:<p>- If the crucial parts of the devices that &quot;were modified to improve accuracy&quot; were modified early on in the study the data could be representative of the final product.<p>- The same applies for the devices not being fully assembled. If they weren&#x27;t fully assembled, and the data were still good enough to defend a 510k, then the data should represent worst case usage, unless full assembly would somehow make the technology less performant.