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The Advantage Lumbar System - ALIF, PLIF, TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Advantage Lumbar – ALIF, PLIF, TLIF's implants are interbody fusion devices intended for use as an aid in spinal fixation. These hollow, rectangular implants are offered in a variety of widths, lengths, heights, and lordotic angles designed to adapt to a variety of patient anatomies. They have serrations on the superior and inferior surfaces designed for fixation, ergonomically shaped anterior edges, and flat posterior edges. Radiopaque markers have been embedded within the implants, which are designed to allow for visualization in radiographic images.

The provided document is a 510(k) summary for the Intelivation LLC's Advantage Lumbar System, which is an intervertebral body fusion device. The document explicitly states that no performance testing was required for this device.

The rationale provided is that the "subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring names of systems that have already been cleared under K121567 and K131981."

Therefore, based on the provided text, it is not possible to describe acceptance criteria or a study that proves the device meets the acceptance criteria, as no such study was conducted or deemed necessary by the FDA for this particular 510(k) clearance due to the device's substantial equivalence to already cleared predicates.

All sections of your request related to acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be answered as the submission states no testing was required for this particular device.

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