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

The Biomet Microfixation Sternal Closure System contains a variety of plates and 2.4mm and 2.7mm diameter screws with a minimum length of 8mm and a maximum length of 20mm. The tip of the 2.4mm screw is designed to be self-drilling so that a predrilled hole is not required. There are threaded features on both the plates and screws to allow for the screw to be locked into the plate when fully seated. The plates are manufactured from Commercially Pure Titanium (conforming to ASTM F67) and the screws are manufactured from Titanium Alloy (Ti-6Al-4V conforming to ASTM F136). The devices are sold non-sterile and intended to be sterilized by the user prior to implantation.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

The document is a 510(k) premarket notification decision letter from the FDA to Biomet Microfixation regarding their Sternal Closure System. It confirms that the device is substantially equivalent to legally marketed predicate devices and does not require an approval of a premarket approval application (PMA).

The submission explicitly states:

• "Non-Clinical Performance Data: Non-clinical testing was not necessary for the determination of substantial equivalence."
• "Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence."

Therefore, there is no information about:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, or other details of a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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