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Stryker VariAx 2 MIS Calcaneus is indicated for fractures of the calcaneus.

This Traditional 510(k) submission is submitted to the U.S. FDA to provide authorization to market the VariAx 2 MIS Calcaneus plates. The goal of the Subject Device VariAx 2 MIS Calcaneus is to offer a comprehensive range of calcaneal implants and instruments in one system utilizing the VariAx 2 platform technology and SOMA database for the design of the plates.

The Subject Device VariAx 2 MIS Calcaneus has an equivalent Intended Use and Indications for Use as the Predicate Device and shares the same principle of operation.

Stryker VariAx 2 MIS Calcaneus is a non-active implant(s) intended to provide temporary stabilization for bones or bone fragments.

The provided text describes a 510(k) submission for a medical device called "Stryker VariAx 2 MIS Calcaneus." This document does not include information about AI/ML device performance or clinical studies typically associated with evaluating AI/ML models. Instead, it focuses on the substantial equivalence of a bone fixation appliance to an existing predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them, as the provided text is for a traditional medical device (metallic bone fixation appliances) and explicitly states:

"Clinical testing was not required for this submission." (Page 4)

Here's why the specific points you asked for cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: This document specifies non-clinical testing for mechanical properties (ASTM F382-17) and MRI compatibility, but it does not present a table of performance metrics for an AI/ML device.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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