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When used as a pedicle screw fixation system, the Nu Vasive Reline System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients 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)

When used for posterior non-cervical screw fixation in pediatric patients, Nu Vasive Reline System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the NuVasive Reline System is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

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. Pseudoarthosis
7. Tumor resection and/or
8. Failed previous fusion

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

The NuVasive Reline System is a pedicle screw system that consists of a variety screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. This 510(k) is to add new components to the Reline System.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets them because the provided text describes a 510(k) premarket notification for the "NuVasive® Reline™ System" which is a pedicle screw spinal system.

The document is an FDA clearance letter and a 510(k) summary, and it primarily focuses on establishing substantial equivalence to existing predicate devices based on design, intended use, material composition, and function. The "Performance Data" section mentions nonclinical testing (e.g., dynamic compression bending per ASTM F1717) but does not provide quantitative acceptance criteria or detailed results that would allow me to populate a table of acceptance criteria and reported device performance.

Furthermore, this type of device (spinal fixation system) does not typically involve the kinds of studies (e.g., standalone algorithm performance, MRMC studies, expert consensus on image interpretation, training/test set data provenance, ground truth establishment for AI/diagnostics) that would be needed to answer the specific questions posed about device performance for an AI/diagnostic device. The information requested is relevant to AI/machine learning medical devices, which this product is not.

Therefore, I cannot fulfill the request as the provided text relates to a different type of medical device lacking the details you are asking for.

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