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The VariAx Foot system is intended for use in internal fixation or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures include but are not limited to:

• · Replantation
• · Lag screw techniques
• · Joint fusions
• · Corrective osteotomies
• Treatment of fractures

VariAx Foot is a system used for internal fixation applications. VariAx Foot consists of self-fapping locking and non-locking screws, as well as corresponding washers and compatible bone plates. Since its original submission (K063875), the screws of the system have been modified. The modification includes the addition of a cutting flute to the 2.7mm and 3.5mm locking and nonlocking screws and a change in the Tox head of the 2.7mm screws. The lengths of the 2.7mm diameter screws range from 8-50mm. The lengths of the 3.5mm diameter screws range from 10-70mm.

This document is a 510(k) premarket notification for the VariAx Foot system, a metallic bone fixation appliance. It is a submission to demonstrate substantial equivalence to a predicate device, not a study evaluating device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert review, adjudication methods, and MRMC studies is not applicable to this type of regulatory submission.

Here's why and what information can be extracted:

• No Acceptance Criteria or Device Performance Study (in the sense of AI/ML or diagnostic accuracy): This 510(k) submission is for a physical medical device (bone fixation system). The "acceptance criteria" here are related to demonstrating substantial equivalence for regulatory approval, primarily through non-clinical testing focused on mechanical properties and biocompatibility. It's not about the accuracy or performance of an algorithm or diagnostic tool.
• No Sample Sizes for Test/Training Sets, Ground Truth, Experts, or Adjudication: These concepts are relevant to studies evaluating diagnostic accuracy, often in AI/ML contexts. This submission discusses mechanical testing, not diagnostic performance.
• No MRMC or Standalone Studies: Again, these are specific to evaluations of diagnostic or AI-assisted tools, which the VariAx Foot system is not.

While the requested table and categories are not directly applicable, I can provide a summary based on the information that is present in the document.

Summary of Device and Regulatory Submission:

The VariAx Foot system is a metallic bone fixation appliance used for internal fixation or arthrodesis of small bones in the foot and ankle, and treatment of fractures, among other procedures.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable: This document describes a 510(k) submission for a physical medical device, not a study involving a "test set" in the context of diagnostic accuracy or AI/ML. The "testing" referred to is non-clinical mechanical and biocompatibility testing. The data provenance would be from internal lab testing by Stryker GmbH.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable: No "ground truth" or "experts" for diagnostic assessment are mentioned or relevant to this type of submission.

4. Adjudication method for the test set

• Not Applicable: No adjudication method for a "test set" is mentioned or relevant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This is a physical bone fixation device, not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: This is a physical bone fixation device, not an algorithm.

7. The type of ground truth used

• Not Applicable: No "ground truth" (in the sense of diagnostic accuracy) is mentioned. The "truth" in this context is the physical and biological performance of the device as assessed through non-clinical methods.

8. The sample size for the training set

• Not Applicable: No "training set" is relevant to this device or submission.

9. How the ground truth for the training set was established

• Not Applicable: No "training set" or "ground truth" for it is relevant to this device or submission.

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