(184 days)
Device is intended for use in surgical procedures to provide surgical access to the spine by placing the retractor in incision prepared by the surgeon down towards the land the sure is michael for use in surgical procedures to provide surgical access to the specifical access to the splacing .
Self-Retaining Lumbar Retractor
The provided document is a 510(k) premarket notification letter from the FDA to Koros USA, Inc. regarding a Self-Retaining Lumbar Retractor. It is a regulatory approval document confirming substantial equivalence to a predicate device.
This document does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is a Class I device and does not typically require extensive performance studies for 510(k) clearance. The information requested in the prompt (acceptance criteria table, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are typically found in the 510(k) submission itself or in a detailed study report, not in the FDA's clearance letter.
Therefore, I cannot fulfill your request using the provided input.
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.