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The Zavation ALIF System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Zavation ALIF System is to be filled with autogenous bone graft material.

The Zavation ALIF System spacer and plate assembly are an integrated for stand-alone use when used with screws. When used with anchors only the recessed plate may be used, and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.

Hyperlordotic interbody devices (>20 dogrees) must be used with supplemental fixation (c.g. posterior fixation) that has been cleared by the FDA for the use in the lumbar spine.

The Zavation ALIF System includes a spacer, plate, screws, and anchors. The spacer component is assembled to an interbody plate and implanted anteriorly. The spacer components are available in a variety of materials, depths, widths, and heights. The plate component includes three or four holes for inserting bone screws or anchors. The plate component also includes a lock at each hole. The bone screws are available in a variety of diameters and lengths. The anchors are available in a variety of lengths. The interbody plate components are available in a variety of heights.

The provided text does not contain information about acceptance criteria and the study that proves a device meets them in the context of an AI-powered medical device. Instead, it is a 510(k) premarket notification summary for the Zavation ALIF System, which is an intervertebral body fusion device (a physical implant) and not an AI device.

Therefore, I cannot extract the requested information like expert qualifications, adjudication methods, MRMC studies, or training/test set details, as these are specific to the evaluation of AI/ML-based medical devices.

The document discusses the mechanical performance of the physical implant against ASTM standards, but not the performance of an AI algorithm. If you have a document describing an AI device's performance study, please provide it.

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