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The TiBrid™ SC standalone cervical fusion device is indicated for use in anterior cervical interbody procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. The implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The device is to be used is patients who have had six weeks of non-operative treatment. The cervical standalone intervertebral body fusion device is to be used with either two bone screws and a screw locking cover or a connecting plate. If the connecting plate is chosen, the number of screws should correspond to the number of holes in the plate.

The TiBrid™-SC system consists of a standalone hybrid PEEK OPTIMA™ HA Enhanced and titanium alloy cervical interbody device with 3 titanium plate options (two, three, and four screws) that can be connected to the standalone device. The standalone cages are available in multiple footprints and heights, and have a lordotic angle of 6°. The plates are available in multiple heights. The cages feature a hollow center to accommodate autograft or allograft and include anti-migration features. All devices are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

The provided text describes a 510(k) premarket notification for a medical device (Omnia Medical TiBrid™-SC) and does not contain information about the acceptance criteria or a study proving the device meets those criteria for an AI/ML product.

The document is a submission to the FDA for an intervertebral body fusion device, which is a physical implant used in spinal surgery, not a software or AI/ML-based device. The "acceptance criteria" discussed in the document are about demonstrating substantial equivalence to existing predicate devices based on design, materials, dimensions, function, and mechanical testing results (e.g., static and dynamic compression, subsidence, expulsion testing).

Therefore, I cannot extract the requested information regarding an AI/ML device's acceptance criteria and study from this document. The questions posed in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are relevant to the evaluation of AI/ML products, but not to the type of medical device described in this 510(k) submission.

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