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The DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone.

System indications include the following:
o Open reduction and internal fixation of fractures, mal-unions, and non-unions
o Following excision of benign bone tumors
o Replantations and reconstructions
o Arthrodeses of joints involving small bones
o Osteotomies, including deformity correction such as rotation, lengthening, shortening
o Pathological fractures, including impending pathologic fractures

The DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) consists of stainless steel and titanium plates and screws that offer screw-to-plate locking designed for various fracture modes of the hand. The plates and screws contained in the DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) are offered in a range of configurations to accommodate patient anatomy and surgical need. The subject system contains two plate and screw sizes, 1.3 mm and 2.0 mm, general instruments, and device specific instruments. The 1.3 mm plates in this submission are designed to accept new 1.3 mm cortex and locking screws. The 2.0 mm plates are designed to accept existing 2.0 mm cortex screws, 2.0 mm locking screws, and new 2.0 mm Variable Angle (VA) locking screws. The new 2.0 mm VA locking plates and screws feature existing variable angle locking technology (K100776).

This document is a 510(k) premarket notification for the DePuy Synthes Variable Angle Locking Hand System. It is a submission to the FDA for a medical device, which means it describes the device and its intended use, but it does not contain information about an AI/ML-driven device or study results of the type you're asking for.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device from this document. This document pertains to a physical medical implant (plates and screws for hand fracture fixation).

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