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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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The MONDRIAN™ Lumbar Interbody Fusion Cage 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. The system is to be used with supplemental fixation cleared for use in the lumbar spine. Hyperlordotic cage offerings (>20°) require the use of anterior fixation. 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. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The MONDRIAN™ Lumbar Interbody Fusion Cage system is intended for use as an interbody fusion cage device to maintain lumbar intervertebral spacing and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA LT1 –or- PEEK VESTAKEEP i-Grade with Tantalum marker pins; titanium alloy; or a combination of PEEK, Titanium Alloy, or both.

The MONDRIAN™ Lumbar Interbody Fusion Cage System consists of cages made out of PEEK with marker pins made of Tantalum or Titanium alloy, both of which are identical to its predicate device. All of the heights, lengths, and widths are similar and/or within ranges covered by its predicate devices.

This document describes the MONDRIAN™ Lumbar Interbody Fusion Cage System and its substantial equivalence to predicate devices, not an AI/ML powered medical device. Therefore, much of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable.

However, I can extract information related to the device's performance and the studies conducted to demonstrate its safety and effectiveness.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MONDRIAN™ Lumbar Interbody Fusion Cage System are based on demonstrating equivalent mechanical performance to predicate devices under the same test conditions. The "reported device performance" is that it met these criteria.

Study Details (as applicable to a physical medical device submission):

• Sample sized used for the test set and the data provenance: Not explicitly stated as a separate "test set" in the context of an AI/ML device. The "test set" here refers to the actual physical devices (MONDRIAN™ Lumbar Interbody Fusion Cage System) subjected to mechanical testing. The provenance of these devices would be their manufacturing origin (CTL Medical Corporation). The studies are in vitro mechanical tests.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for mechanical testing is established by engineering standards and measurements, not expert consensus.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Mechanical testing results are objective measurements against established standards and predicate device performance.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical interbody fusion cage, not an AI/ML diagnostic or assistive device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by established engineering and material standards (e.g., ASTM F2026, ASTM F136, ASTM F560, ASTM F899, ASTM B211, ASTM B221) and the demonstrated performance of the predicate devices.
• The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable.

Summary of the Device's Basis for Clearance:

The MONDRIAN™ Lumbar Interbody Fusion Cage System received FDA clearance (K192863) based on substantial equivalence to existing predicate devices (primarily CEZANNE™ and CEZANNE-II™ Lumbar Interbody Fusion Cage Systems). This means its safety and effectiveness were demonstrated by showing it has:

• The same intended uses.
• Similar indications, technological characteristics, and principles of operation.
• No new issues of safety or effectiveness raised by its technological differences.
• Demonstrated equivalent mechanical performance to the cited predicate devices under the same test conditions in the types of tests listed (Static Axial Compression, Static Compression Shear, Dynamic Axial & Compression Shear, Expulsion, Subsidence).

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