(118 days)
The Advantage Magnum Interference Screws are intended to provide early rigid fixation and stability of the bone block in bone/ patellar tendon/ bone graft surgical procedures for Anterior Cruciate Ligament (ACL) reconstruction. They are specifically intended for use in bone tunnels 3 which have been enlarged due to tunnel/graft mismatch or revision of a prior ACL reconstruction.
The Advantage Magnum Screw is a fully threaded, cannulated, Titanium alloy, cancellous bone screw, available in diameters of 11, 13 and 15mm and in lengths of 15, 20, 25 and 30mm. The tip of the screw is tapered to a point which produces the self-tapping feature of the screw. The screw is inserted by a hex drive which is broached into the minor diameter of the screw itself which minimizes the size of the head of the screw. The headless, low profile design minimizes subcutaneous surface protrusions. The large cancellous threads are a symmetrical thread form with a smooth radius at the base of the threads.
This 510(k) summary describes a medical device, the Advantage Magnum Interference Screws, and claims substantial equivalence to a predicate device, the DePuy M. Kurosaka Interference Screws. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance.
Therefore, I cannot provide the requested information for acceptance criteria and a study given the input. This document focuses on the physical characteristics, intended use, and substantial equivalence claim of a traditional orthopedic implant, not an AI/ML powered device.
§ 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.