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The Integra Vu aPOD-L. Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft (i.e. autograft). The Integra Vu aPOD-L Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate.

Degenerative disc disease is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment.

The Integra Vu aPOD-L. Intervertebral Body Fusion Device consists of spinal fusion cages, optional internal buttress plates, as well as instrumentation designed specifically for the implantation of these devices. The spinal fusion cages are offered in heights of 8-16mm, lengths of 44-64mm, widths of 18mm and 23mm, and lordotic angled geometries to accommodate variations in patient anatomy. The cages include teeth on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The cages contain an open central channel for receiving bone graft to allow for bony in-growth in and around the implant. The cages can be used in combination with an optional titanium spin plate and contain radiographic markers. The devices are manufactured from Polyetheretherketone (PEEK-OPTIMA LT-1) per ASTM F2026, Titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and Tantalum per ASTM F560.

The provided document (K112986 for the Integra Vu aPOD-L Intervertebral Body Fusion Device) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria and performance studies in the context of AI/ML devices or clinical trials is not explicitly available in this type of submission.

However, I can extract the relevant information from the document as it pertains to the device's "performance" in the context of a 510(k) submission.

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

In the context of this 510(k), "acceptance criteria" are analogous to the successful completion of specified mechanical tests to demonstrate that the device performs equivalently to the predicate.

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

• Sample Size for Test Set: Not applicable in the context of this mechanical testing. The standards specify how many samples of the device components should be tested to meet the ASTM standards. This information is not detailed in the 510(k) summary but would be part of the full design control documentation.
• Data Provenance: The data comes from in vitro mechanical testing performed by the manufacturer, Integra Spine, LLC, based in Medina, OH, USA. This is not retrospective or prospective clinical data but rather laboratory-generated data.

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

This is not applicable. The "ground truth" for mechanical testing is established by the specified ASTM standards and the measurements obtained during testing against those standards. No expert consensus is involved in defining the physical properties and performance metrics of the device in this context.

4. Adjudication method for the test set:

Not applicable. Mechanical testing results are objective measurements against predefined standards.

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 device is an intervertebral body fusion device and does not involve AI or human readers in its function. No MRMC study was performed.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used:

• For the mechanical performance, the "ground truth" is defined by adherence to the performance criteria outlined in the ASTM standards (ASTM F2077, ASTM F2267) and successful demonstration of functional equivalence to the predicate device.

8. The sample size for the training set:

Not applicable. This device did not involve machine learning; therefore, there was no "training set."

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

Not applicable. No training set was used.

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