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When used as an interbody fusion device, the PROLIFT® Wedge Expandable Implant System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The PROLIFT® Wedge Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired lordosis (0-15°) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the PROLIFT® Wedge Expandable Spacer System components with components from any other system or manufacturer. The PROLIFT® Wedge Expandable Spacer System components should never be reused under any circumstances.

This document is a 510(k) summary for the PROLIFT® Wedge Expandable Spacer System, an intervertebral body fusion device. It does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study proving device performance for such a device. The content focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and mechanical performance testing (static/dynamic compression, static/dynamic shear, and subsidence).

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML powered device as this document does not pertain to one.

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