(36 days)
The Osteomed Extended 2.0/2.4 Cannulated Screw System is indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.
The OsteoMed Extended 2.0/2.4 Cannulated Screw System is comprised of screws in diameters of 2.0mm (length 6mm to 42mm) to 2.4mm (length 6mm to 52mm). The screws are made from titanium alloy (ASTM F-136). Depth gauges, screwdrivers, drills, countersinks, k-wires, and preparation instruments will also be a part of the system.
The provided text is a 510(k) summary and FDA clearance letter for a medical device, specifically the "OsteoMed Extended 2.0/2.4 Cannulated Screw System." This document is not a study report and therefore does not contain any information about acceptance criteria, device performance metrics (such as sensitivity, specificity, or AUC), sample sizes for test or training sets, ground truth establishment, or expert involvement for assessing AI or algorithmic performance.
This device is a physical medical implant (bone screw system) and its clearance is based on substantial equivalence to previously marketed predicate devices, not on the performance of a software algorithm or AI.
Therefore, I cannot provide the requested information. The document focuses on regulatory compliance, intended use, material composition, and design similarities to existing devices, rather than a clinical or technical performance study in the way an AI/software device would be evaluated.
§ 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.