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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 (1.3 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 -Pedicle Screw System consists of a variety of polyaxial screws, uni-planar screws, rods, 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.

While the provided text describes the NuVasive SpheRx II - Pedicle Screw System and its intended uses, it does not contain any information about acceptance criteria or a study proving the device meets those criteria.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results. It explicitly states "Summary of Clinical Tests (Not Applicable)," indicating that no clinical studies were submitted for this 510(k) clearance.

Therefore, I cannot provide the requested information for the acceptance criteria and study details.

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