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The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

The Extremity Medical Calcaneal Osteotomy Device is a bone fixation device consisting of a bracket and lag screws and a set of instruments used for implant site preparation and delivery. The bracket is offered in height sizes of 6mm to 13mm. The Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

The provided document describes the FDA 510(k) premarket notification for the Extremity Medical Calcaneal Osteotomy Device. This device is a bone fixation device, not an AI/ML medical device, and therefore the concepts of acceptance criteria, device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable in the context of AI regulatory submissions.

The document indicates that the device's substantial equivalence was based on non-clinical testing, specifically bench testing for static and dynamic bending, which was performed and compared to a predicate device. No clinical testing was performed.

The relevant information regarding this device's "acceptance criteria" (though not explicitly stated as such in the AI/ML context) would be its ability to demonstrate substantial equivalence to legally marketed predicate devices through its design, material mechanical properties, indications for use, and performance in these non-clinical bench tests.

To answer your request based on the provided document and keeping in mind it's for a physical bone fixation device:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implied): Substantial equivalence to predicate device in terms of design, material mechanical properties, indications for use, and performance in static and dynamic bending bench tests.
   • Reported Device Performance: "Bench testing static and dynamic bending were performed and compared to the predicate device." (Specific numerical performance data is not provided in this summary document.)

2. Sample size used for the test set and the data provenance: Not applicable as this is a physical device and no "test set" in the context of data for AI/ML is mentioned. The testing refers to physical bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML models is not relevant here.

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: No, this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" for this physical device's performance would be its mechanical properties measured in bench tests and compared to the predicate device.

8. The sample size for the training set: Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

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