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When used as a pedicle screw fixation system in skeletally mature patients, the NuVasive Reline System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in 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 Nu Vasive Reline 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 Reline 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. Pseudoarthrosis
7. Tumor resection and/or
8. Failed previous fusion

When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline System is indicated as an adjunct to fusion to treat:

1. adolescent idiopathic scoliosis.
2. progressive spinal deformities (i.e., scoliosis, or lordosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis,
3. spondylolisthesis,
4. spondylolysis,
5. pseudarthrosis,
6. failed prior fusion and
7. fracture caused by tumor and/or trauma in pediatric patients.

Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

In order to achieve additional levels of fixation, the NuVasive Reline System rods may be connected to the Armada System.

The NuVasive Reline System is a pedicle screw system that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to introduce "Dual-Headed Modular Connectors" which will be included in the NuVasive Reline System. Additionally, this submission is intended to specify pediatric progressive deformities in the indications for use statement for NuVasive Reline System. Lastly, this submission is intended to add minor labeling changes to address compatibility updates to the NuVasive Reline system.

The provided document describes the NuVasive Reline System, a pedicle screw system, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that a device meets specific acceptance criteria in the context of diagnostic accuracy or clinical outcomes.

The "Performance Data" section (G) on page 6 refers to nonclinical testing, which are engineering tests to assess the physical properties and mechanical performance of the device. These are distinct from clinical studies designed to evaluate diagnostic accuracy or the effectiveness of AI algorithms.

Therefore, I cannot fulfill the request as the document does not provide the necessary information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study related to meeting such criteria.

The information provided is focused on demonstrating substantial equivalence for a medical device (pedicle screw system), primarily through design comparison, material composition, and mechanical testing according to established ASTM standards.

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