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The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF, LLIF, TLIF and T-PLIF system. Two devices are used per intervertebral space for the PLIF system.

The Spinal USA Interbody Fusion Device ALIF, LLIF, T-PLIF and PLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenous bone graft. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device.

The Spinal USA Interbody Device Stabilizer RPIF System is intended to be used only in anterior procedures in which an ALIF device of the same height is implanted. The Stabilizer RPIF device is not meant for stand alone use.

The Spinal USA Interbody Fusion Device consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and graft material size. All components are manufactured from Ti-6AI-4V titanium alloy (ASTM F136) or medical grade polyetheretherketone (Peek LT1). The products are supplied clean and "NON-STERILE".

This is a 510(k) summary for a Spinal USA Intervertebral Body Fusion Device. It outlines the device description, intended use, and equivalence to previously cleared devices. However, the provided document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is purely a regulatory submission stating the product's intended use and its substantial equivalence to other devices, which is the basis for its 510(k) clearance by the FDA. It does not include any performance data or clinical study results.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance studies based on the provided text. The requested information is not present in the given document.

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