(90 days)
This device is used in general management of fractures and reconstructive surgery.
Not Found
Since the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Triage Medical, Inc. Helical Compression Anchor), it does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth.
This document is a regulatory clearance letter, confirming that the device is substantially equivalent to a predicate device and can be marketed. It does not provide the technical details of any performance studies that would have been submitted to support this claim.
To answer your request, I would need access to the actual 510(k) submission or a summary thereof, which typically includes the performance data and methodology.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.