(84 days)
To provide interference fixation of soft tissue graft and bone-tendon-bone patellar graft during cruciate ligament repair through arthroscopy or arthrotomy.
The titanium cannulated interference screw is tapered and has a smooth threaded design, which provides interference fixation of soft tissue grafts and bone-tendon-bone patellar grafts during cruciate ligament repair through arthroscopy or arthrotomy. The screw comes in lengths between 20 and 50 mm and diameters between 7mm and 12mm, resulting in a screw adapted to the morphology of the graft and patient.
The provided text is a 510(k) summary for a medical device (Titanium Cannulated Interference Screw) and the associated FDA clearance letter. It is not a study report for an AI/ML powered device. As such, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen in AI/ML performance evaluation.
The FDA clearance for this device is based on substantial equivalence to a predicate device (Alaron interference screw K010595), not on performance metrics against specific acceptance criteria for an AI/ML algorithm.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set info) from the provided text because it describes a traditional medical device, not an AI/ML device, and its clearance process is different.
§ 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.