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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.

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