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When used as an interbody fusion device, the ProLift® Expandable 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. This 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 internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The ProLift Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 20mm) 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 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 Expandable System components with components from any other system or manufacturer. The ProLift Expandable System components should never be reused under any circumstances.

This document describes the ProLift® Expandable System, an intervertebral body fusion device, and its 510(k) clearance. However, the provided text does not contain any information regarding acceptance criteria, device performance studies (like sample size, ground truth, expert qualifications, or MRMC studies), or details about an AI/algorithm-based device.

The document is purely a regulatory submission for a physical medical device (an expandable spinal implant) and focuses on demonstrating its substantial equivalence to previously cleared predicate devices based on design, materials, indications for use, and mechanical performance testing of the device itself, not any associated software or AI.

Therefore, I cannot fulfill your request for the specific information about acceptance criteria and a study proving device performance as it relates to an AI/algorithm.

If your request was mistakenly assuming this document refers to an AI/algorithm, please clarify or provide a different document.

Based on the provided text, the closest I can get to relevant sections are:

1. A table of acceptance criteria and the reported device performance:

The document mentions mechanical performance testing. While it doesn't provide a table of acceptance criteria or specific numerical performance results, it states what tests were performed:

The rest of the requested information (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set information) is not present in this document as it pertains to AI/algorithm performance, not a physical implant's mechanical characteristics.

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When used as an interbody fusion device, the ProLift® Expandable 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. This 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 internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The ProLift® Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) 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 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 ONL Y and should not be reused under any circumstances. Do not use any of the ProLift® Expandable System components with components from any other system or manufacturer. The ProLift® Expandable System components should never be reused under any circumstances.

The provided document is a 510(k) premarket notification for a medical device called the ProLift® Expandable System, an intervertebral body fusion device. This type of regulatory filing focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving efficacy or safety through clinical trials with defined acceptance criteria for a device's performance.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes for test/training sets, expert qualifications, adjudication methods, or ground truth establishment relevant to AI/algorithm performance.

Instead, the "Performance Data" section (page 4) refers to:

• Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077. This is mechanical testing to demonstrate the structural integrity and equivalence of the device to predicate devices, not performance related to clinical outcomes or diagnostic accuracy for an AI system.

The document explicitly states: "The ProLift® Expandable System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance." This underlines that the focus is on equivalence in physical and mechanical properties and intended use, not on a performance study comparing diagnostic accuracy or clinical effectiveness against specific acceptance criteria.

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