(87 days)
The Pain Concepts' Dekompressor™ Percutaneous Lumbar Discectomy Probe is intended for use for the aspiration of disc material during percutaneous lumbar discectomies.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "Dekompressor™ Percutaneous Lumbar Discectomy Probe." It indicates that the device has been found substantially equivalent to a predicate device already on the market.
However, this document does not contain any information regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance), or training set information for an AI/algorithm.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is purely about regulatory clearance, not about a detailed performance study of an AI-powered device.
§ 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.