(116 days)
The Smith & Nephew DYONICS Power II Shaver System control unit is indicated for use, when used with appropriate procedure specific blades, for resection of soft and osseous tissues including, but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.
Not Found
This is a 510(k) premarket notification for a medical device (Smith & Nephew DYONICS Power II Shaver System), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/ML study is not applicable.
The provided document describes the regulatory classification of the device, its indications for use, and confirms that it has been found substantially equivalent to predicate devices. It does not contain information about performance studies in the context of an AI/ML model.
§ 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.