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The VariTrax Sternal CircumFixation system is indicated for primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

The VariTrax Sternal CircumFixation System consists of polyetheretherketone (PEEK) locking bands with a detachable stainless-steel needle and a PEEK buttress plate. They are single-use devices provided in a sterile kit. The VariTrax bands are placed in peristernal fashion through the intercostal space with the help of the detachable needle. Once inserted, the needle is removed and the VariTrax implants are attached and locked to the VariTrax buttress plate, then tightened and secured in place to provide stable fixation of the sternum.

The provided document is a 510(k) premarket notification for a medical device (VariTrax Sternal CircumFixation System), not a study report or a publication detailing acceptance criteria and study results for an AI/ML powered device. Therefore, it does not contain the information requested in the prompt.

The document discusses various tests for the device, such as biocompatibility and mechanical performance (lateral distraction, longitudinal shear, static tensile band, four-point bend, and needle pull out) to demonstrate substantial equivalence to predicate devices. However, this is for a physical medical device, not an AI/ML software.

The concepts of "acceptance criteria," "reported device performance," "sample sizes for test and training sets," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "type of ground truth" are typically relevant for the evaluation of AI/ML-powered medical devices. Since the VariTrax Sternal CircumFixation System is a physical bone fixation device, these specific metrics for AI/ML evaluation are not applicable and thus not present in the provided text.

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