(62 days)
The Bone Reduction Screw is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.
The ARC Surgical Bone Reduction Screw is a headless, cannulated twopiece screw assembly. The two-piece design incorporates the use of a distal and proximal screw component. The implant is used to anatomically reduce two bone portions. The distal screw component engages the distal bone portion and the proximal screw component engages the proximal bone component.
The provided text makes no mention of an AI/ML device or its performance criteria. The submission is for a "Smooth or threaded metallic bone fixation fastener" named the "Arc Surgical Bone Reduction Screw System." The document primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device. The document explicitly states: "A discussion of clinical and non-clinical tests is not applicable." because the device is a simple mechanical device with well-established uses.
§ 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.