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When used as a pedicle screw fixation system, the NuVasive SpheRx 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 posterior thoracic, lumbar, and sacral 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. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3. Fracture
4. Dislocation
5. Scoliosis
6. Kyphosis
7. Spinal tumor and/or
8. Failed previous fusion (pseudoarthrosis)

The NuVasive SpheRx Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive SpheRx Spinal System is also intended for the following indications:

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 SpheRx II System consists of a variety of polyaxial screws, fixed angle screws, rods, hooks, locking nuts, and transverse connectors. 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 text is a 510(k) summary for the NuVasive SpheRx II System, a pedicle screw system. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.

Specifically:

• No acceptance criteria table or reported device performance data is present.
• No information on sample size, data provenance, number of experts for ground truth, or adjudication methods is provided.
• No multi-reader multi-case (MRMC) comparative effectiveness study or standalone performance study is mentioned.
• The type of ground truth used for any study (which is not described) is not specified.
• No information on training set sample size or how ground truth for a training set was established is available.

The only "testing" mentioned is a "Summary of Non-Clinical Tests" which states: "Mechanical testing was presented." There is no further detail about what mechanical tests were performed, what the results were, or what the acceptance criteria for those tests were. The "Summary of Clinical Tests" explicitly states "(Not Applicable)".

Therefore, based on the provided text, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them.

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