(86 days)
Fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand
The Auto-Drive™ bone screws are available in 1.6 mm and 2.0 mm diameters with lengths ranging from 4 mm to 8 mm.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.
The provided text is a 510(k) summary and approval letter for the OsteoMed Auto-Drive Bone Screw, focusing on its substantial equivalence to previously marketed devices. It describes the device's intended use, materials, design, and operational principle, and states that equivalence is based on these similarities. It does not contain any details about a study conducted to prove the device meets specific acceptance criteria in terms of performance metrics.
§ 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.