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When used as a pedicle screw fixation system, the NuVasive SpheRx MAS Deformity 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 SpheRx MAS Deformity 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 NuVasive SpheRx 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 SpheRx II-Pedicle Screw 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 additional sizes of screw shanks, tulips, lock screws, load rings, and split rings that have been added to the SpheRx II-Pedicle Screw System platform and are designated as SpheRx II - MAS Deformity Spinal System.

This document describes a 510(k) premarket notification for the NuVasive SpheRx II - MAS Deformity Spinal System, an orthopedic implant. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving enhanced clinical performance or an AI-driven analysis. Therefore, many of the typical acceptance criteria and study details for AI/software as a medical device are not applicable here.

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

1. Table of Acceptance Criteria and Reported Device Performance

For this particular device submission (a 510(k) for an orthopedic implant), the "acceptance criteria" are related to demonstrating substantial equivalence in terms of mechanical performance and technological characteristics to an already marketed predicate device.

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

The document does not specify a "test set" in the context of clinical data or AI model evaluation. The performance data is derived from non-clinical mechanical testing.

• Sample size for mechanical testing: Not explicitly stated in the document. ASTM F1717 standards would typically define the minimum number of samples for such tests.
• Data provenance: Not applicable in the context of country of origin for clinical data or retrospective/prospective study design, as this refers to bench testing.

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

This information is not applicable as the "test set" refers to mechanical testing, not a dataset requiring expert annotation for ground truth.

4. Adjudication method for the test set

This information is not applicable as the "test set" refers to mechanical testing, not data requiring expert adjudication.

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 comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of this 510(k) submission for an orthopedic implant.

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. This submission is for a physical medical device (spinal system), not a software algorithm.

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

The "ground truth" for this device's performance is established by validated mechanical testing standards (ASTM F1717), not expert consensus, pathology, or outcomes data. The "ground truth" essentially reflects the physical properties and performance characteristics defined by these standards.

8. The sample size for the training set

This information is not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable. As above, there is no AI/ML training set mentioned in this document.

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