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The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula, in patients with normal bone density and osteopenic bone, for the following indications:

· osteotomies, mal-unions, and non-unions

· single, segmental, and comminuted fractures

The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-271mm in length.

The provided text is related to a 510(k) premarket notification for the "VariAx 2 Compression Plating System". This document is a regulatory submission for a medical device (bone fixation appliance), not an AI/ML powered device, and therefore does not contain information about acceptance criteria or studies as they relate to AI/ML device performance.

The document states: "Clinical testing was not required for this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device from this text. The questions posed in your prompt (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) are specific to AI/ML device evaluation, which is not applicable to the content of this regulatory submission.

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