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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 treatment of 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 NuVasive® Precept™ Spinal 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 Nu Vasive 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. Pseudoarthosis
7. Tumor resection and/or
8. Failed previous fusion

The NuVasive Precept Spinal System consists of a variety of polyaxial screws, reduction screws, offset connectors, rods, locking nuts, and transverse connectors. Implant components 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 for the modification to a component used in the assembly of tulip to screw shanks of polyaxial screws. The system as a whole remains unchanged compared to the predicate (K102514).

The NuVasive® Precept™ Spinal System is a medical device, and the provided text describes its 510(k) summary for premarket notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy in a clinical study with acceptance criteria and statistical analysis as would be typical for a new drug or high-risk medical device.

Therefore, many of the requested elements for a study proving device meets acceptance criteria are not applicable in this context, as a clinical study with human subjects, ground truth, and expert adjudication was not conducted for this 510(k) submission. Instead, the device's performance was evaluated through non-clinical (mechanical) testing.

Here's a breakdown of the requested information based on the provided text:

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

Note: The specific numerical acceptance criteria (e.g., maximum force, displacement limits) for each mechanical test are not explicitly detailed in the provided summary, only that the device "met or exceeded" the performance of predicate devices or relevant standards (ASTM F1798).

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated in the document. For mechanical testing, this would refer to the number of individual components or assembled systems tested.
• Data Provenance: The tests were nonclinical (mechanical) and conducted by NuVasive, Inc. at their facilities, likely in the USA (San Diego, California).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This was a non-clinical, mechanical testing submission. There was no "ground truth" to be established by experts in the context of clinical interpretation or diagnosis. The "ground truth" for mechanical testing is typically defined by engineering standards and specifications.

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

• Not applicable. As this was mechanical testing, no human adjudication of clinical outcomes or interpretations was performed.

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. No MRMC or clinical comparative effectiveness study involving human readers or AI assistance was performed. This submission is for a physical spinal implant system, not a diagnostic imaging or AI-driven decision support tool.

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

• Not applicable. This relates to AI/algorithm performance. The NuVasive® Precept™ Spinal System is a physical medical device (pedicle screw system), not an algorithm.

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

• Mechanical Testing Standards: For the mechanical tests (static/dynamic flexion-extension, tulip pull-off, tension-torsion, orbital tension), the "ground truth" or reference for performance is established by industry standards (e.g., ASTM F1798) and the performance of the predicate devices. The goal was to show that the modified device's performance was equivalent to or better than these established benchmarks.

8. The sample size for the training set

• Not applicable. There was no "training set" as this was a non-clinical mechanical testing for a spinal implant, not a machine learning model.

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

• Not applicable. As there was no training set, this question does not apply.

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