(82 days)
The Synthes Locking Compression Plate (LCP) System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone. The Synthes LCP Distal Tibia Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the Synthes Small Fragment LCP System.
The Synthes LCP Distal Tibia Plates are machined metallic plates that offer screw to plate locking designed for various fracture modes of the distal end of the tibia and other small bones.
This is a 510(k) premarket notification for a medical device (bone fixation plates), not an AI/ML device. Therefore, the provided document does not contain information related to acceptance criteria, study performance, sample sizes, ground truth, or any other metrics typically associated with the evaluation of AI/ML device performance.
The document states that the device, Synthes LCP Distal Tibia Plates, was found to be "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a previously cleared device. The type of information requested (acceptance criteria table, sample sizes for test/training sets, expert qualifications, etc.) is not applicable to a traditional 510(k) clearance process based on substantial equivalence for a physical medical implant.
Therefore, I cannot provide the requested information from the given text as it pertains to AI/ML device evaluation.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.