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VariAx 2 Foot System is indicated for internal fixation of bones in the foot, ankle, hand, and adolescent (12 - 21 years) patients, which includes replantation, joint fusions, corrective osteotomies, and osteopenic bone.

VariAx 2 Foot System is a system used for internal fixation and is composed of sterile and nonsterile plates, and instruments. This system also uses compatible instruments and compatible screws from other systems. These contoured plates are made of Grade II, commercially pure titanium, with Type II anodization. They are available in a variety of sizes and shapes, and are designed to accept locking and non-locking screws, as well as k-wires for temporary fixation during initial placement.

This submission extends K141992 by introducing additional plates, additional instruments, and expands the indications.

The provided FDA 510(k) summary for the Stryker VariAx 2 Foot System does not contain information about acceptance criteria or a study proving its performance in the context of an AI/algorithm-based diagnostic device. This document is for a metallic bone fixation appliance, and the "Performance Data" section refers to mechanical testing of the device's physical properties, not diagnostic accuracy or clinical outcomes of an algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies because these concepts are not applicable to the type of device described in the document.

The document explicitly states:

• "Non-Clinical Testing: Comparative mechanical testing to predicate systems demonstrated substantial equivalence." This refers to tests like "Dynamic Bending" and "Static Stiffness" of the physical plates and screws.
• "Clinical Testing: Clinical testing was not a requirement of this submission." This confirms that no studies involving human subjects for clinical outcomes or diagnostic performance were conducted or required for this submission.

Thus, a table of acceptance criteria and reported device performance for an AI/algorithm would be empty, and all other points about diagnostic study design are not relevant to this submission.

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