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When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Long Lateral Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the spine: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities, (5) fracture, (6) pseudoarthosis, (7) tumor resection, and/or (8) failed previous fusion.

The NuVasive Long Lateral System consists of a variety. of screws, rods, lock screws, and staples. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.

The provided document is a 510(k) summary for the NuVasive® Long Lateral Spinal System, a medical device for spinal fixation. It details the device description, intended use, and substantial equivalence to predicate devices, but does not describe acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance or AI/algorithm performance.

Instead, the performance data discussed relates to the mechanical and physical performance of the spinal implant device, demonstrating its structural integrity and comparability to existing devices.

Therefore, I cannot provide the requested information. The document does not contain:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI.
2. Sample sizes for test sets or data provenance for AI/diagnostic studies.
3. Number or qualifications of experts for ground truth establishment for AI/diagnostic studies.
4. Adjudication method for AI/diagnostic studies.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study for AI.
6. Information on standalone (algorithm only) performance.
7. Type of ground truth used for AI/diagnostic studies.
8. Sample size for a training set for AI.
9. How ground truth for a training set for AI was established.

The "Performance Data" section (G) in the document refers to nonclinical testing, specifically:

• Static and dynamic compression testing per ASTM F1717
• Static torsion testing per ASTM F1717
• Implantation Cadaver Study

These tests are designed to demonstrate the structural and mechanical equivalence of the new spinal system to predicate devices, not its diagnostic or AI performance. The conclusion is that the device "meets or exceeds the performance of the predicate device" in these mechanical tests, thus establishing substantial equivalence for market clearance.

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