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The OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.
OsteoMed ExtremiLOCK Wrist Plating System implants are intended for single use only.

The OsteoMed ExtremiLOCK Wrist Plating System is a rigid fixation and fusion system consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification and implantation. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking and non-locking heads and are either fully threaded or partially threaded in various lengths. These screws are either solid core or cannulated and can be used with or without plates. The system also contains smooth variable angle locking pegs and K-wire implants.
The implants of the OsteoMed ExtremiLOCK Wrist Plating System are made from Titanium per ASTM F-67 (Plates), Titanium Alloy per ASTM F-136 (plates, screws, pegs and washer), and Stainless Steel per ASTM F-138( K-wires). The modifications to the plates include the new material of CP Titanium per ASTM F-67 and the screw modifications include the new dual lead technology. The rest of the system has already been cleared through OsteoMed wrist predicate 510(k) K120015. The modification also introduced new sterile packaging configurations for the implants and disposable instruments. The system instruments included facilitate modification and insertion of the implants.

The provided text describes the OsteoMed ExtremiLOCK Wrist Plating System, a medical device, and the basis for its 510(k) clearance. It does not contain information about a study proving that the device meets acceptance criteria related to a diagnostic or AI-driven system.

The "Performance Characteristics & Testing & Clinical" section explicitly states: "Clinical Testing is not required to support substantial equivalence." Instead, the performance evaluation was based on mechanical strength testing of the plates and screws compared to predicate devices.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving a device meets them, as the provided document does not detail such a study in the context of diagnostic performance, AI, or human-in-the-loop improvements. The information requested (acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is typical for the validation of diagnostic algorithms or AI systems, which is not what this document describes for the OsteoMed ExtremiLOCK Wrist Plating System.

The document focuses on the mechanical and material performance of a bone fixation system, establishing substantial equivalence to existing predicate devices based on:

• Mechanical strength testing: Plates and screws were tested against predicate devices to ensure they met required mechanical strength criteria for their intended use.
• Material comparison: The system uses materials (Titanium, Titanium Alloy, Stainless Steel) per ASTM standards, similar to predicates.
• Design and Technology: Similarities in design, technology (e.g., variable angle locking), and operational principles to predicates.

In summary, the provided text discusses regulatory clearance for a medical device based on non-clinical, mechanical performance comparisons, not a clinical study assessing diagnostic accuracy or AI performance.

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The Acumed Hand Plating System is intended for the management of fractures, fusions, and osteotomies of the distal, middle, and proximal phalanges and metacarpals and other bones of appropriate size for the devices.

The Hand Plating System consists of plates, locking screws, lag screws, and k-wires. Plates are available in a variety of shapes to accommodate varying fracture patterns and/or patient anatomy. The plates come in thicknesses of 0.8 mm to 1.3 mm. The locking screws and lag screws have major thread diameters of 1.5 mm to 2.3 mm, provided in lengths ranging from 5 mm to 20 mm. The lag screws and k-wires are used for fixation independent of the plates. The plates are made of titanium per ASTM F-67. The screws, lag screws, and the k-wires are made of titanium alloy per ASTM F136. All plates and screws are provided sterile and non-sterile.

The provided text describes a 510(k) submission for the Acumed Hand Plating System, which is a medical device for orthopedic fixation. It does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based device.

The document explicitly states: "The non-clinical testing enclosed in this submission includes static and cyclic performance testing and engineering analysis." This refers to mechanical and engineering tests, not studies related to algorithm performance or human-in-the-loop improvements.

Therefore, for your request regarding AI/algorithm acceptance criteria and studies, the provided text does not contain the necessary information. It is a traditional medical device submission focused on substantial equivalence to existing predicate devices based on design, materials, and mechanical performance.

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