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The VertebraLINK Fusion Platform is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via posterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The VertebraLINK Fusion Platform is a comprehensive suite of generally box shaped devices which can be implanted into the prepared disc space when performing an intervertebral body fusion. The devices are manufactured from Invibio's PEEK Optima LT1 or PEEK Optima HA Enhanced per ASTM F2026. The devices contain a central axial opening for packing of bone graft material as well as teeth on the inferior and superior surfaces to resist expulsion. The platform will be offered in multiple lengths, widths, heights and lordoses to accommodate varying anatomies, pathologies, surgeon preferences, or techniques (i.e., TLIF, PLIF, or Oblique PLIF). Additionally, the device contains radiographic markers made from tantalum per ASTM F560.

The provided document is a 510(k) summary for the VertebraLINK Fusion Platform, an intervertebral body fusion device. While it indicates that performance testing was conducted, it does not provide specific acceptance criteria or the detailed results (performance data) that would allow for the completion of the requested table. It only states that the results "show that the strength of the VertebraLINK Fusion Platform is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Therefore, based solely on the provided text, I cannot fill in the table of acceptance criteria and reported device performance. Additionally, most of the other requested information regarding the study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this regulatory document, as it focuses on demonstrating substantial equivalence through non-clinical testing.

Here's what can be extracted and noted about the unavailable information:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that testing was completed, but does not provide specific numerical acceptance criteria or the quantitative reported performance of the device against those criteria. It only offers a general conclusion of sufficiency and 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 test set: Not specified. The performance data section refers to "the results of this non-clinical testing," but does not mention the number of samples or devices tested for each type of test.
• Data provenance: Not explicitly stated, as these are non-clinical (mechanical) tests rather than clinical studies with 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 information is relevant for studies involving human interpretation (e.g., radiological reads for AI diagnostics). The provided document describes premarket non-clinical mechanical testing, not a study involving experts to establish ground truth for a diagnostic output.

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

• Not applicable. As above, this pertains to studies involving human interpretation or clinical decision-making.

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

• No, an MRMC comparative effectiveness study was not done. The document describes non-clinical mechanical performance testing of an intervertebral fusion device, not an AI-enabled diagnostic device requiring human reader assessment.

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

• Not applicable. This device is an implantable medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance tests mentioned (Static axial compression, Dynamic axial compression, Expulsion, Subsidence, Bacterial Amebocyte Lysate) are indeed "standalone" in the sense that they evaluate the device itself without human interaction or a system loop, but this is a different context than what is typically implied by "standalone algorithm performance."

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

• For the non-clinical mechanical tests, the "ground truth" would be defined by engineering standards and specifications (e.g., specific load requirements, displacement limits, or bacterial count thresholds outlined in the ASTM and AAMI standards referenced). There isn't a "ground truth" in the clinical sense of a disease state.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm that requires a training set. The performance testing described is for physical characteristics.

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

• Not applicable. As this is not an AI algorithm requiring a training set, this question is not relevant.

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