(90 days)
The TenoScope is indicated for the visualization and diagnosis of a severed tendon which has retracted within its diagnosis of a severed conacial by non-invasive maneuvers.
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This document is a 510(k) clearance letter from the FDA for a device called "TenoScope". It does not contain information about acceptance criteria, device performance, test studies, sample sizes, or expert qualifications. It is purely regulatory correspondence confirming that the device is substantially equivalent to a predicate device and can be marketed.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.