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The ProLift® Lateral HELO Fixated is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogence back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ProLift® Lateral HELO Fixated is to be filled with autograft and/or allogenic bone graft comprised of cancellous bone. The ProLift® Lateral HELO Fixated must be used with FDA cleared supplemental fixation. The ProLift® Lateral HELO Fixated may optionally be used with two bone screws.

The ProLift® Lateral HELO Fixated is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints 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. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and 6.5mm and lengths of 25mm-60mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.

All implants are provided and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Lateral HELO Fixated with components from any other System or manufacturer. The ProLifi® Lateral HELO Fixated components should never be reused under any circumstances.

The provided text is a 510(k) summary for a medical device called "ProLift Lateral HELO Fixated," which is an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a standalone study with acceptance criteria and device performance results in the context of an AI-powered diagnostic device or a study involving human readers.

Therefore, many of the requested fields are not applicable to the information contained in this FDA 510(k) submission.

Here's an analysis based on the provided text, indicating where information is not applicable:

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

The document does not explicitly state acceptance criteria in a table format with corresponding reported device performance values as would be expected for a diagnostic AI study. Instead, it refers to performance data from mechanical testing.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample size for test set: Not applicable. This is a mechanical testing study, not a clinical study with patient data. The "test set" would refer to the number of devices or constructs tested. The specific number of devices tested for each mechanical test is not provided in this summary.
• Data provenance: Not applicable. The data is from mechanical testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This is a mechanical testing study, not a study requiring expert clinical review or diagnosis to establish ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is a mechanical testing study. Adjudication methods are relevant for clinical studies or studies using human readers.

5. 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 document describes a submission for a physical medical device (intervertebral body fusion device), not an AI-powered diagnostic system. No MRMC study was conducted or is relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This document is for a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the mechanical testing would be defined by the standardized testing protocols (ASTM F2077) and the physical properties of the materials and device design. The "acceptance" is based on meeting or exceeding the performance of the predicate device under these standardized conditions.

8. The sample size for the training set

Not applicable. This is a medical device clearance based on substantial equivalence and mechanical testing, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The study referenced is based on mechanical performance testing to demonstrate the safety, effectiveness, and substantial equivalence of the ProLift® Lateral HELO Fixated device to its predicate devices.

Study Type: Mechanical Performance Testing

Tests Conducted:

• Static axial compression
• Dynamic axial compressive shear
• Dynamic compressive shear

Standard Used: ASTM F2077 (Standard Test Methods for Intervertebral Body Fusion Devices)

Comparison: The performance of the ProLift® Lateral HELO Fixated was compared to the Pro-Lift Expandable System (K173182) to demonstrate substantial equivalence.

Conclusion: The information presented, including the mechanical testing, demonstrated the substantial equivalency of The ProLift Lateral HELO Fixated in terms of indications for use, design, function, materials used, and mechanical performance to its predicate devices. The implicit "acceptance criteria" were met by demonstrating that the device performed comparably to, or better than, the predicate device under the established ASTM F2077 standards. Specific numerical results of these tests are not included in this summary.

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