(116 days)
Bone screws are used to fix fractured long and short bones. They are also used to fasten bone plates. Bregma International manufactures three kinds of bonc screws, Aach with its own intended use. Cortical bone screws are used to augment compact and hard bones (diaphyseal reglons of the bones). Cancelluus bone screws are used in the epiphyseal and metaphyseal reglons of the bones which are largely soft and spongy. Cannulated bone screws, are used in situations where surgical wire is required to pass through the central axis of the screw, along which a holes has been drilled.
Not Found
The provided text is a 510(k) clearance letter from the FDA for Bone Screws, Kirschner Wire, and Steinman Pins. It states that these devices are substantially equivalent to devices marketed prior to May 28, 1976. This type of clearance does not involve the kind of detailed study data and acceptance criteria that would be found for a novel medical device requiring de novo classification or PMA.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as such studies were not required for this specific 510(k) clearance. The FDA's determination here is based on the devices being "substantially equivalent" to existing, legally marketed predicate devices, not on new performance data demonstrating meeting specific, novel acceptance criteria through a clinical or performance study of the type usually associated with AI/software devices.
§ 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.