(195 days)
The KSEA magnifying arthroscopes and accessories are intended for use by qualified surgeons during arthroscopic procedures of the small and large joints. Specific arthroscope models are intended for arthroscopic procedures of the shoulder and knee; arthroscopic procedures of the elbow, ankle, wrist and jaw; and arthroscopic procedures for the shoulder, knee and illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint".
The KSEA magnifying arthroscopes are manually operated, reusable surgical devices consisting of a rigid arthroscope with a ring for adjusting the magnification of the image The arthroscopes are long enough to gain access to the surgical site. The body contact materials are surgical grade stainless steel.
I am designed to extract information from regulatory documents for AI/ML-driven medical devices. The document you provided is a 510(k) summary for a "Karl Storz Magnifying Arthroscope" from 1996.
This device is a manually operated, reusable surgical device and is not an AI/ML-driven medical device. Therefore, the concepts of acceptance criteria, study designs with test sets, training sets, ground truth, expert adjudication, or MRMC studies that prove device performance in the context of AI/ML are not applicable to this document.
The document discusses "substantial equivalence" to predicate devices based on basic features, design, and intended uses, which is a common pathway for traditional medical devices to demonstrate safety and effectiveness.
If you have a document pertaining to an AI/ML medical device, I would be happy to analyze it for 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.