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When used as a pedicle screw fixation system, the NuVasive GSB Global Spinal Balance 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:

• I. Degenerative 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 GSB Global Spinal Balance System is also indivated 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 GSB Global Spinal Balance System is also intended for the following indications:

• 1.Degenerative disease (as defined by back pain of discogenic origin with deveneration of the disc confirmed by patient history and radiographic studies)
• 2. Spinal stenosis
• 3. Spondvlolisthesis
• 4. Spinal deformities
• 5.Fracture
• 6. Pseudoarthosis
• 7. Tumor resection and/or
• 8. Failed previous fusion

The NuVasive GSB Global Spinal Balance System (hereto referenced as the GSB 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 contigurations to suit the individual pathology and anatomical conditions of the patient.

The provided 510(k) summary for the NuVasive® GSB Global Spinal Balance System ([K132014](https://510k.innolitics.com/search/K132014)) describes a medical device with mechanical performance requirements, not an AI/ML powered device. As such, the typical acceptance criteria and study designs found in AI/ML performance evaluations (e.g., sample size for test/training sets, ground truth by expert consensus, MRMC studies) are not applicable here.

Instead, the acceptance criteria and study details provided relate to non-clinical mechanical and material testing to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Study that proves the device meets the acceptance criteria:

The study performed was nonclinical testing described in section G. "Performance Data." The objective was to demonstrate substantial equivalence to predicate devices by comparing the mechanical properties of the NuVasive GSB Global Balance System to established performance benchmarks for such devices, as defined by ASTM F1717 and a "Tulip pull-off" test. The summary states that "The results demonstrate that the subject NuVasive GSB Global Balance System is substantially equivalent to the predicate."

Regarding the AI/ML-specific questions (2-9), this information is NOT applicable or available for this type of medical device submission:

2. Sample sized used for the test set and the data provenance: Not applicable. The tests are mechanical, not data-driven for AI/ML.
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 mechanical testing is based on engineered specifications and test results against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Mechanical test results are objective measurements.
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. This is a spinal implant system, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device refers to physical properties meeting mechanical specifications and safety standards.
8. The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable. There is no training set for an AI/ML algorithm.

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