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When used as an interbody fusion device, the PROLIFT® Wedge 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 allogeners bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal 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-6AI-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.

The provided text describes a medical device called the "ProLift Wedge Expandable Spacer System" and its 510(k) submission to the FDA. This document is a regulatory clearance letter and summary, not a study report that would typically include detailed acceptance criteria and performance data for an AI/ML medical device.

Therefore, the information required to populate the table and answer your specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies for an AI/ML algorithm is not present in the provided text.

The document states:

• "Performance Data: Static compression, dynamic compression, static shear and dynamic shear testing according to ASTM F2077 & load induced subsidence and static expulsion according to F2267, was presented to demonstrate the substantial equivalency of the Life Spine ProLift Wedge Expandable Spacer System (K203361)." This indicates mechanical testing was performed for a physical intervertebral body fusion device, not a software algorithm.

Based on the information provided, I cannot answer the questions as they pertain to the evaluation of an AI/ML device.

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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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