(243 days)
The implants of the Foot and Hand Motion System are indicated for the fixation of bone fractures and for bone reconstruction in the hand and forefoot surgery.
Not Found
This document is an FDA 510(k) clearance letter for the "Newclip Foot and Hand Motion System". It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).
The request asks for specific details about these aspects, but they are not present in the given FDA letter. This type of document typically confirms regulatory clearance based on substantial equivalence to existing devices, and often refers to supporting data supplied by the manufacturer in their 510(k) submission, rather than detailing the studies themselves within the clearance letter.
Therefore, I cannot provide the requested information from the given text.
§ 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.