(36 days)
These devices are indicated for use in endoscopic carpal ligament release.
The KSEA arthroscopes for use in endoscopic carpal ligament release are straight-shafted, rod-lens telescopes. Accessories are available for use with the arthroscopes include sheaths, obturators, knives, dilators, and a retractor with guiding tube. The body contact materials present in these devices are commonly used in medical devices for a wide range of applications, and have a long history of biocompatability for human use.
The provided text describes a 510(k) summary for Karl Storz Endoscopy instruments, focusing on their substantial equivalence to predicate devices for endoscopic carpal ligament release.
However, the document does not contain any information regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication methods), or AI-related effectiveness studies (MRMC or standalone).
Therefore, I cannot extract the requested information. The text primarily addresses regulatory aspects of substantial equivalence based on design and intended use, rather than detailed performance study outcomes.
§ 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.