(61 days)
This instrument is indicated for arthroscopic procedures of the shoulder, knee and also for the illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint.
The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope 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.
This document is a 510(k) summary for a medical device (endoscope), not a study evaluating a device's performance against acceptance criteria using AI. Therefore, I cannot extract the requested information regarding AI device performance.
The provided text describes:
- A 510(k) submission for the Karl Storz DCI Endoscope.
- The device's identification, indication for use, and description.
- A statement of substantial equivalence to predicate devices.
- The FDA's decision letter confirming substantial equivalence and allowing the device to be marketed.
None of the information you requested regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details for AI devices is present in this regulatory submission for a conventional endoscope.
§ 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.