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The TM Ardis® Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies: Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.

The TM Ardis® Interbody System device is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

The TM Ardis® Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-SI. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.

The provided text describes a 510(k) premarket notification for the "TM Ardis® Interbody System." This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than a clinical study evaluating diagnostic accuracy or a human-AI comparison. Therefore, many of the requested categories related to clinical studies, ground truth, expert involvement, and AI performance metrics are not applicable or cannot be extracted from this specific document.

Here's the breakdown of the information that can be extracted and a clear indication of what cannot be determined:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by the referenced ASTM standards and FDA guidance documents for mechanical performance. The reported performance is a qualitative statement of compliance.

Study Details

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

   • Sample Size: Not applicable. This document refers to mechanical testing of the device itself, not a clinical study involving human patients or a test set of data. The "sample size" would refer to the number of devices tested, which is not specified but would be aligned with standard mechanical test protocols.
   • Data Provenance: Not applicable, as it's mechanical testing, not patient data.

2. 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. Ground truth, in this context, would be the physical properties and performance metrics measured during mechanical testing, established by engineering and testing standards, not by human experts interpreting clinical data.

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

   • Not applicable. This is not a clinical study requiring adjudication of expert interpretations.

4. 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 mechanical testing of an intervertebral body fusion device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assistance evaluation was performed.

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

   • Not applicable. This is not an algorithm or AI device.

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

   • Ground Truth: The "ground truth" for this device is its physical and mechanical performance characteristics as measured against established engineering standards (ASTM F2077-03, ASTM F2267-04) and FDA guidance documents for intervertebral body fusion devices. This is a physical/mechanical ground truth, not a clinical or diagnostic ground truth.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • Not applicable. There is no training set for this type of device submission.

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