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The Biomet Microfixation SternaLock® System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation SternaLock® System is intended for use in patients with normal and poor bone quality.

The Biomet Microfixation SternaLock® System is composed of metallic locking bone plates and locking screws that provide stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).

The provided text is a 510(k) summary for the Biomet Microfixation SternaLock® System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a specific device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy. Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of medical device submission (AI/ML device evaluation) and not a mechanical fixation system.

However, I can extract information related to non-clinical testing performed and acceptance criteria met for the mechanical device:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. The document states "Non-Clinical Performance Data: The following non-clinical testing has been performed and met all established acceptance criteria: Magnetic Resonance Testing per ASTM F2182-11." This is likely referring to a materials compatibility test, not a diagnostic accuracy study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This information is relevant for studies involving human interpretation or diagnostic accuracy, which is not the type of study described here.

4. Adjudication method (e.g., 2+1, 3+1, none) 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. This device is a mechanical fixation system, not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used: For the Magnetic Resonance Testing, the ground truth would be established by the specifications of the ASTM F2182-11 standard itself, which defines the acceptable magnetic properties of the material. There isn't a "ground truth" in the sense of a medical diagnosis.

8. The sample size for the training set: Not applicable. This document describes non-clinical testing for a device, not the training of an AI model.

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

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