(68 days)
The Synthes Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the stemum to stabilize the sternum and promote fusion.
The Synthes Titanium Locking Plates feature compression screw holes which accept existing 2.4 and 3.0mm locking screws, have notched sides and undersides. The plates are available in lengths of 96 and 160mm with 12 and 20 holes.
This 510(k) summary (K052683) is for a medical device (Synthes Sternal Fixation System), not an AI/ML powered device. As such, the concepts of acceptance criteria for algorithm performance, sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.
This submission focuses on demonstrating substantial equivalence to a predicate device based on its intended use, design, and materials, primarily through descriptive information rather than performance studies that would involve "device performance" in the context of an AI algorithm.
Therefore, I cannot provide the requested information in the format of acceptance criteria and a study that proves the device meets those criteria, as it is outside the scope of this type of medical device submission.
§ 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.