(224 days)
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The provided text is an FDA 510(k) clearance letter for the device "Vera" by Reflexion Health, Inc. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance data, study design parameters (sample size, data provenance, expert qualifications, adjudication methods), or details about training sets or ground truth establishment.
Therefore, I cannot extract the requested information from the provided text. The document is essentially a regulatory clearance notice, not a clinical study report or a technical performance specification document.
§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.