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The Turbo Prime IBD (Interbody Device) System is indicated for use 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 who have had at least six months of non-operative care for their DDD. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The Turbo Prime IBD System is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-ELI).

The provided text describes a 510(k) premarket notification for the "Turbo Prime IBD System," an intervertebral fusion orthosis. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance testing with specific metrics.

Here's a breakdown of what can be extracted or inferred, and what is missing:

The document states:
"The pre-clinical testing performed indicated that the Turbo Prime IBD System is adequate for the intended use."

This is a very general statement and does not provide specific acceptance criteria or performance metrics. It implies that some testing was done to ensure the device's suitability, but the details of that testing, including "acceptance criteria" and "reported device performance," are not disclosed in this summary.

Therefore, the requested tables and details about the study cannot be fully compiled from the provided text.

Specifically, the following information is missing or cannot be determined from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document only generically states "pre-clinical testing performed indicated that the Turbo Prime IBD System is adequate for the intended use."
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
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 mentioned. This device is an implantable medical device (orthosis), not an AI-assisted diagnostic or imaging device, so such a study would likely be irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, and likely not applicable given the device type.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Conclusion:

The provided 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices (Inter Fix Threaded Fusion Device, Ray Threaded Fusion Cage, and BAK Interbody Fusion Device) based on "same indications for use, design, function, and materials used." While it mentions "pre-clinical testing performed indicated that the Turbo Prime IBD System is adequate for the intended use," it does not provide the specific details of this testing, including acceptance criteria, performance metrics, study design, or ground truth establishment as requested.

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