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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 have major thread diameters of 1.5 mm to 2.3 mm and are provided in lengths ranging from 5 mm to 20 mm. The lag screws have major thread diameters of 1.5 mm to 2.3 mm, provided in lengths ranging from 8 mm to 18 mm.The lag screws and k-wires are used for fixation. The plates are made of titanium per ASTM F-67. The screws, lag screws, and the kwires are made of titanium alloy per ASTM F136.

The provide document is a 510(k) summary for the Acumed Hand Plating System, which is a medical device, not an AI/ML powered device. Typically, 510(k) summaries for such devices focus on demonstrating substantial equivalence to a predicate device through material, design, and intended use comparisons, often supported by mechanical testing rather than clinical study data involving human readers or ground truth for AI algorithms.

Therefore, the requested information, such as acceptance criteria in the context of AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth types for AI models, cannot be extracted from this document.

The document states:

• Non-clinical testing: "Engineering analysis was conducted that proved that the 1.5 and 2.3 mm Hexalobe Lag Screws can be used with the Acumed Hand Plates." This indicates mechanical or design verification, not a clinical study as described in your request.
• Substantial Equivalence Comparison: "safety and effectiveness is adequately supported by the substantial equivalence information, materials information, and analysis provided within this Premarket notification. The proposed Acumed Hand Plating System and the predicate devices consist of same technological characteristics, design features, materials of composition, and intended use." This is the primary "proof" for a traditional 510(k) device, not performance against acceptance criteria derived from a clinical study for an AI.

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