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The Intraosseous Fixation System is intended for reduction of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the hand, wrist, foot and ankle, appropriate for the size of the device.

The Extremity Medical Intraosseous Fixation System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunion of the small bones and joints of the hand, wrist, foot, and ankle. The system consists of solid and cannulated screws, with the option of adding Washers; a standard/flat Washer, a Washer Post (referred to as an X-Post) for engaging the head of the Screw, and an X-Clip for engaging the threads of the screw. The X-Post/X-Clip come in varying sizes and lengths. Similarly, the lag screws come in varying diameters and lengths, and are also available in short and long thread configurations. The modified device is a product line extension and improvement to the Screw and Washer System, cleared under K121349, intended to provide modularity to the end user. New components to the system consist of cannulated 3.5 mm screws and implant accessories, X-Posts and X-Clips, to offer surgeons options for placement. Additionally, the system will offer additional thread length options for the 4.5mm screws cleared under K121349 and 6.5mm screws substantially equivalent to those cleared under K121349.

This document, K201556, pertains to a 510(k) premarket notification for a medical device called the "Intraosseous Fixation System," manufactured by Extremity Medical, LLC. It is a Class II device (21 CFR 888.3040) classified as a smooth or threaded metallic bone fixation fastener.

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria for software or an AI/ML algorithm. The document describes a traditional medical device (implants for bone fixation) and its substantial equivalence to predicate devices based on design, materials, and mechanical properties. There is no mention of an AI/ML component, image analysis, or any performance metrics typically associated with such systems.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, test set details, ground truth establishment, or human reader studies related to an AI/ML device, as none of that information is present in the provided FDA 510(k) clearance document.

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