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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)

The Nu Vasive Reline System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-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

When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline System is 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.

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 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. The purpose of this submission is to introduce design modifications to previously cleared components and add iliac saddle to previously cleared Reline System.

This document describes a 510(k) premarket notification for the NuVasive Reline System, a thoracolumbosacral pedicle screw system.

Here's an analysis based on your request, but please note that this type of FDA 510(k) summary typically does not include detailed clinical study data with acceptance criteria, sample sizes, expert qualifications, or MRMC studies for traditional orthopedic implants like pedicle screw systems. Instead, it relies heavily on substantial equivalence to predicate devices and mechanical performance testing.

Therefore, many of the requested points below will be answered with "Not applicable/provided" or explanations about why such details are not present in this type of submission.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided document. The testing seems to be based on mechanical (bench) testing, not patient data.
• Data Provenance: Not applicable, as no human data is described. The engineering rationale and mechanical testing would be conducted in a laboratory setting.
• Retrospective/Prospective: Not applicable, as no human data is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/provided. This device is a mechanical implant, and its performance for 510(k) relies on mechanical testing and substantial equivalence to existing devices, not clinical ground truth established by medical experts in an diagnostic or interpretive sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/provided. As there's no clinical test set with human assessments or interpretations, adjudication methods are not relevant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/provided. This is a spinal implant, not an AI software/diagnostic device. MRMC studies are not relevant to its 510(k) clearance process described here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/provided. This is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable in the clinical sense. The "ground truth" for this type of device typically refers to engineering specifications, material properties, and the performance standards established by predicate devices and ASTM standards, validated through mechanical testing.

8. The sample size for the training set

• Not applicable/provided. This refers to the training of an algorithm or AI model, which is not relevant to this device's submission.

9. How the ground truth for the training set was established

• Not applicable/provided. This refers to the ground truth for an AI model's training, which is not relevant to this device's submission.

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