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AccelFix Lumbar Expandable Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. AccelFix Lumbar Expandable Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The AccelFix Lumbar Expandable Cage System's implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). 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. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.

• · AccelFix-XT Expandable Cage is to be implanted via transforaminal and posterior approach.
• . AccelFix-XTP Expandable Cage is to be implanted via Anterior to Psoas approach and lateral Approach.
• AccelFix-XL Expandable Cage is to be implanted via lateral approach.

I am sorry, but the provided text does not contain information about the acceptance criteria for a medical device or a study proving that the device meets those criteria. The document appears to be an FDA 510(k) summary for the "AccelFix Lumbar Expandable Cage System," primarily discussing its substantial equivalence to a predicate device based on design, materials, manufacturing processes, and mechanical testing.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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