(90 days)
The KSEA C-Mount Arthroscope is intended for large joint arthroscopic procedures.
These instruments are manually operated surgical devices intended for arthroscopic procedures of the shoulder and knee.
The Karl Storz C-Mount Arthroscope are manually operated surgical devices. The KSEA C-Mount Arthroscope are 30° and 70° view Telescopes. The body contact portions of the KSEA C-Mount Arthroscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
The provided document is a 510(k) summary for the Karl Storz C-Mount Arthroscope, which is a manually operated surgical device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies, as described in your request.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from clinical or standalone studies. Therefore, I cannot extract the requested information from this document.
§ 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.