(95 days)
The arthroscope and accessories are intended to be used by a licensed physician, for the purpose of joint arthroscopic procedures.
ADI 9000/9001 arthroscope and accessories.
The provided text is a 510(k) clearance letter from the FDA for an arthroscope and accessories. It does not contain any information about acceptance criteria, device performance, a study, or details about ground truth, sample sizes, or expert adjudication related to performance metrics.
The letter merely states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory matters such as general controls, GMP compliance, and labeling, but not clinical or performance study results.
Therefore, I cannot provide the requested information.
§ 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.