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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-S1. 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 is fabricated from surgical grade stainless steel and other applicable materials. TM Ardis Interbody System was cleared via 510(k) number K113561 on May 29, 2012.

The TM Ardis® Inserter instrument, that is the subject of this premarket notification, is intended for use with the TM Ardis® Interbody System. This instrument is designed specifically for use with the TM Ardis® Implants and is considered an accessory to the implants.

This 510(k) summary describes a modification to an accessory instrument (TM Ardis® Inserter instrument) for an already cleared intervertebral body fusion device (TM Ardis® Interbody System). The information provided focuses on the substantial equivalence of the modified instrument to the original, rather than the primary device's clinical performance. Therefore, many of the requested categories related to clinical studies and AI performance are not applicable.

Here's the breakdown of the available information:

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

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not specified. The document refers to "Design Verification and Design Validation Testing," which would typically involve a sample of the modified inserter instruments. However, the specific number of units tested is not provided.
• Data provenance: Not explicitly stated, but it would be internal testing performed by Zimmer Trabecular Metal Technology, Inc. There is no mention of external data or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This relates to clinical studies and ground truth establishment, which are not detailed for this instrument modification. The evaluation is based on mechanical performance testing and comparison to a predicate device.

4. Adjudication method for the test set

• Not applicable. This relates to clinical studies and expert review, which are not described for this instrument modification.

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 submission is for an interbody system's inserter instrument, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or reported.

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

• Not applicable. As mentioned above, this is not an AI device.

7. The type of ground truth used

• Not explicitly defined as "ground truth" in the context of clinical outcomes. For the mechanical testing, the "ground truth" would be the pre-defined engineering specifications and performance benchmarks for the inserter instrument, likely based on industry standards and internal design requirements.

8. The sample size for the training set

• Not applicable. This is not an AI device, so there is no "training set."

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

• Not applicable. As this is not an AI device, there is no "training set" or ground truth for such a set.

Summary of the Study:

The study referenced is an internal design verification and validation testing of the modified TM Ardis® Inserter instrument. The purpose was to demonstrate that the changes (design change to the Inserter Locking Nut and a dimensional change of the Inserter Body Housing) did not negatively impact the instrument's performance and that it remained substantially equivalent to the original, already-cleared predicate device.

The study involved mechanical performance testing to ensure the modified inserter met its design specifications, particularly regarding its ability to release the implant and axial clearance. The results indicated that the acceptance criteria were met, confirming that the modified inserter performs as intended and is substantially equivalent to the predicate device in terms of safety and effectiveness.

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