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The Arthrex Pilon Fusion Plates are intended to be internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, tibia, and calcaneous.

The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, Humeral Fracture Plates and Osteotomy Plates.

The Arthrex Pilon Fusion Plate System are a family of contoured plates and screws. The Arthrex Pilon Fusion Plates are manufactured from Titanium conforming to ASTM F136 and are available in a variety of configurations. The Arthrex Pilon Fusion Plates are intended to be used with solid locking and non-locking Low Profile Screws. The proposed plates are sold sterile or non-sterile and single use.

The proposed Arthrex Low Profile Screws are offered in a 3.5mm diameter, length range of 85 to 120 mm, in a solid and fully threaded design. The screws are manufactured from Titanium conforming to ASTM F136 and are sold sterile or non-sterile and single-use.

The provided FDA 510(k) clearance letter and summary for the Arthrex Pilon Fusion System do not contain information about a study proving that a device meets acceptance criteria related to artificial intelligence (AI) or software performance.

The document describes a medical device, which is a system of plates and screws for internal bone fixation. The performance data presented refers to mechanical testing of the plates and screws (e.g., insertion torque, failure torque, 4-point bend testing, pull-out testing) to demonstrate substantial equivalence to predicate devices. There is also mention of MR compatibility testing.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI/software device meets acceptance criteria from the provided text.

Based on the nature of the document (510(k) for orthopedic implants), it is highly unlikely to contain such information. This type of submission focuses on the physical and mechanical properties of the device, biocompatibility, and substantial equivalence to existing predicate devices, not AI or software performance.

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