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The Synthes CABP System is a plate and screw system intended to treat fractures of the proximal humerus and distal tibia. Proximal humerus fractures include two-part greater tubercle fractures and fracture dislocations, two-part surgical neck fractures and fracture dislocations, three-part fractures or fracture dislocations, fractures in osteopenic bone. and nonunions and malunions. Distal tibia fractures include acute fractures, fractures in osteopenic bone, and nonunions and malunions.

The CABP is a straight plate with a blade at the head to allow for better fixation in the head of the humerus or in the distal tibia. The blade of the plate is cannulated to fit over a guide wire, allowing for the adjustment of the wire placement several times without adversely affecting the final result. There are cuts in the undersurface of the plate to reduce the surface area of the plate in contact with bone. The area of contact between the plate and the bone is decreased in an effort to reduce damage to the cortical blood supply under the plate, and resultant reduction in damageinduced porosis and remodeling of the bone near the plate undersurface. Plate undercuts also make the bending properties of the plate more uniform. which facilitate contouring. The plate has round and dynamic compression screw holes, accepts 4.5 mm and 6,5 mm screws, is available in multiple blade lengths, and is manufactured from stainless steel and commercially pure titanium.

The provided document describes a medical device, the Synthes (USA) Cannulated Angle Blade Plate (CABP) System, and its clearance process with the FDA. However, it does not contain any information about acceptance criteria, a study proving the device meets those criteria, or any performance metrics, sample sizes, expert involvement, or adjudication methods.

The document is a 510(k) submission summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device for market approval. This type of submission relies on the existing safety and efficacy data of the predicate device, rather than requiring new clinical studies with defined acceptance criteria for the new device.

Therefore, I cannot provide the requested information from the given text. The document's purpose is not to detail a performance study but to establish regulatory clearance based on equivalence.

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