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DYNAMIK Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. DYNAMIK Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

DYNAMIK range of products consists of lumbar Interbody cages available in various models to adapt to anatomical variations and surgical techniques. DYNAMIK cages are manufactured as single solid-machined piece made of PEEK conforming ASTM F2026. Markers made of titanium conforming ASTM F136 are used to visualize the position of the implant in the disc space. DYNAMIK Lumbar Interbody Devices are made of PEEK conforming ASTM F2026 with a titanium marker made of TA6V 4 ELI conforming to ISO 5832.3 and ASTM F 136 and are supplied sterile. DYNAMIK Lumbar Interbody Devices are supplied with DYNAMIK Lumbar Interbody Device is indicated for

The provided text describes the DYNAMIK Intervertebral Body Fusion Device, but it does not contain any acceptance criteria or a study that proves the device meets specific performance metrics in the way typically associated with AI/ML device validation.

The document is a 510(k) summary for a medical device (spinal implant), not an AI/ML diagnostic tool. Therefore, information regarding sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth for training was established is not applicable to this type of device submission and is not present in the provided text.

Instead, the performance data provided is related to the mechanical properties and substantial equivalence of the implant, not to diagnostic accuracy or AI performance.

Here's a breakdown of what is available based on your request, highlighting the differences for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. This is a physical implant, not an AI/ML device requiring a diagnostic test set. The "testing" refers to mechanical properties in a lab.

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

• Not applicable. The "ground truth" for this device relates to its mechanical integrity and biocompatibility, which are assessed through material science and engineering tests, not expert interpretation of diagnostic images.

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

• Not applicable. Adjudication is not relevant for mechanical testing.

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 is a spinal implant, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical device, not an algorithm.

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

• The "ground truth" for this device's safety and effectiveness is established through adherence to recognized industry standards (ASTM F2026, ASTM F136, ISO 5832.3) for materials, and mechanical testing standards (ASTM F 2077-03 and ASTM F 2267-04). Additionally, biocompatibility and substantial equivalence to previously cleared devices serve as the basis for approval.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

In summary: The provided document is a regulatory submission for a traditional medical device (intervertebral body fusion device), not an Artificial Intelligence/Machine Learning (AI/ML) powered device. As such, the performance criteria and supporting "study" relate to mechanical properties, material conformance, and substantial equivalence to predicate devices, rather than diagnostic accuracy or AI algorithmic performance metrics.

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