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When used as a pedicle screw fixation system, the NuVasive Precept Spinal 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 Precent Spinal 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 of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Precept 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. Pseudoarthrosis
7. Tumor resection and/or
8. Failed previous fusion

When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Precept Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the NuVasive Precept Spinal 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 NuVasive Precept Spinal System is a pedicle screw system that consists of various screws, lock screws, rods, and associated general instruments. The Precept Spinal System offers a variety of components to suit the individual pathology and anatomical conditions of the patient. The purpose of this 510(k) submission is to introduce a sterile option for the implants and expanded the indications for use to include the treatment of adolescent idiopathic scoliosis.

The provided text is related to a 510(k) premarket notification for the NuVasive® Precept™ Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices based on design, material, function, and performance data from nonclinical testing. It explicitly states that nonclinical testing was performed.

Therefore, the study described does not involve any human-in-the-loop performance, expert ground truth labeling, or a test set of patient data. Consequently, the requested information regarding acceptance criteria for device performance in a clinical setting, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document.

The document details the following performance data, all nonclinical:

1. Acceptance Criteria and Reported Device Performance (Nonclinical Testing):

2. Sample size used for the test set and the data provenance: Not applicable. The provided document details nonclinical, mechanical testing, not a study involving patient data or a test set in the context of AI/algorithm performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant for the nonclinical testing described.

4. Adjudication method for the test set: Not applicable.

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: No, an MRMC study was not done. This document describes nonclinical mechanical testing, not a clinical study involving human readers or AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm performance study was not done. The device is a spinal implant system, not a software algorithm.

7. The type of ground truth used: Not applicable in the context of clinical/AI studies. For the nonclinical tests, the "ground truth" would be the established engineering standards (ASTM F1717, ASTM F1798) and the performance of the predicate device.

8. The sample size for the training set: Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable.

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