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The Frontier LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from L2-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation (i.e. lateral plating or pedicle screw systems), which is in addition to the integrated locking plates provided in the system. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

The Frontier LLC is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and includes associated instrumentation. The body of the implant includes size ranges of 8-16mm wide, 18mm high and lengths of 40-60mm. There are five sizes of locking plates and 5 sizes of corresponding screws. Implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and PEEK Optima LT1. The implant is available with no lordosis built into the implant design.

This document describes a 510(k) premarket notification for a medical device, specifically an interbody fusion device. The focus is on demonstrating substantial equivalence to predicate devices rather than proving specific clinical efficacy through the detailed acceptance criteria and study designs typically associated with novel drug or high-risk device approvals.

Therefore, the requested information elements (1-9) which are typically relevant for AI/software-as-a-medical-device (SaMD) or clinical trial-based approvals, are largely not applicable in this context. This submission relies heavily on bench testing and cadaveric testing to show that the new device performs similarly to existing, legally marketed devices.

Here's how each point applies to the provided information:

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

Explanation: The acceptance criteria are implicit in the tests performed, which aim to demonstrate that the device's characteristics (materials, dimensions, mechanical strength, stability) are comparable to the predicate devices and suitable for its intended use. The "reported device performance" reflects that the device successfully met the requirements of these tests, confirming its substantial equivalence.

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 Bench Testing: Not explicitly stated for each test (e.g., number of specimens tested for axial compression). Common for mechanical testing, a sufficient number of samples would be chosen to ensure statistical significance where applicable or to meet the requirements of the ASTM standards.
• Sample Size for Cadaveric Testing: Not explicitly stated (e.g., number of cadaveric spines/specimens).
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by or for Frontier Medical, LLC. This is pre-clinical data, not patient-derived data, therefore "country of origin of the data" and "retrospective or prospective" are not applicable in the patient data sense. The testing is essentially prospective in that it's designed and executed to evaluate the new device.

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. For a 510(k) submission based on bench and cadaveric testing of a mechanical implant, "ground truth" as it relates to expert clinical opinion or diagnostic accuracy is not relevant. The "ground truth" for the performance is derived directly from physical measurements and observations during the standardized mechanical and cadaveric tests. While engineers and possibly surgeons (for cadaveric implantation) would be involved, they are performing objective measurements and procedures, not establishing a "ground truth" from subjective assessment.

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

• Not Applicable. This concept is relevant for studies involving human assessment of images or clinical outcomes where discrepancies need resolution. For bench and cadaveric testing, results are objective measurements or observations; "adjudication" in this sense isn't used. Test procedures follow established standards (e.g., ASTM F2077-03, ASTM F2267-04) for consistency.

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 type of study is specific to diagnostic aids, often AI-powered, where human readers interpret medical images. The Frontier LLC Interbody Fusion Device is a physical implant for spinal fusion.

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

• Not Applicable. This is relevant for AI algorithms. The Frontier LLC Interbody Fusion Device is a physical medical implant.

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

• Ground Truth for Bench Testing: Established by adherence to industry-standard ASTM test methods and direct physical measurements (e.g., load, displacement, cycles to failure). The "ground truth" is the quantitative result of these standardized mechanical tests.
• Ground Truth for Cadaveric Testing: Established through direct observation and qualitative assessment of implantation safety, stability, and freedom from loosening/dislodgement in human cadaveric spines, likely performed by skilled surgeons or biomechanical engineers.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI algorithm or statistical model for this device. The device itself is directly tested.

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

• Not Applicable. As there is no training set, this question is not relevant.

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