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The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2 – S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.

The Spinal Jaxx Interbody Fusion device is a lumbar intervertebral spacer intended to provide structural stability in a skeletally mature individual based on the surgical intervention by the surgeon. The physician can insert it into the diseased disc space and adjust the height of the device as desired to create near normal disc height. The implants are made from PEEK Optima LT1, a medical grade titanium alloy, CP titanium and Nitinol. Implants are available in various sizes to accommodate patient anatomy. Instruments are made from stainless steel, aluminum, Nitinol, and silicone rubber.

The provided document is a 510(k) premarket notification for a medical device called the "Spinal Jaxx Interbody Fusion Device." It describes the device, its indications for use, and mechanical testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance, results from clinical studies, or details relevant to artificial intelligence/machine learning (AI/ML) device validation.

Therefore, I cannot provide the requested information, as the document focuses on regulatory approval based on mechanical testing and substantial equivalence to existing devices, rather than clinical performance data or AI/ML specific validation.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance for clinical outcomes.
2. Sample sizes used for a test set in a clinical study or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, AI assistance, or effect sizes.
6. Results from a standalone algorithm performance study.
7. Information about the type of ground truth used for clinical validation (e.g., pathology, outcomes data).
8. Sample size for a training set (as this is not an AI/ML device).
9. How ground truth for a training set was established.

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