(42 days)
Both the Auto Suture* Arthroscope** and the Auto Suture* Disposable Arthroscope** (K933576) are intended to be used in orthopedic surgery for the arthroscopic illumination and viewing of joint capsules.
The Auto Suture* Arthroscope** is a reusable arthroscope which has a 30° field of view and a diameter maximum of 4.75 mm. The device utilizes a fiber optic light transmission system to illuminate the joint capsule and an optical system to view the capsule.
The provided text describes a 510(k) submission for an arthroscope, focusing on its description, predicate device, and intended use. It does not contain any information regarding acceptance criteria, device performance metrics, study design, sample sizes, expert involvement, or any form of AI or algorithm performance assessment.
Therefore, I cannot fulfill your request for the detailed description of acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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.