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When used as a pedicle screw fixation system, the NuVasive SpheRx 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® 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 two 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® PPS System consists of a variety of polyaxial screws, 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 document is a 510(k) summary for the NuVasive SpheRx® PPS System, a pedicle screw system. It focuses on the regulatory submission rather than a detailed study proving performance against specific acceptance criteria. Therefore, most of the requested information regarding detailed study design, sample sizes, ground truth establishment, and expert involvement is not present.

However, based on the provided text, we can infer some information:

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

Explanation: The document does not explicitly state acceptance criteria in a quantitative manner (e.g., specific thresholds for tensile strength or fatigue life). Instead, the primary "acceptance criterion" for this regulatory submission is demonstrating substantial equivalence to a previously approved predicate device. This is achieved by showing that the new device has "indications for use identical to those of its predicate, and employs the same principles of operation." Mechanical testing is mentioned as supporting this claim, implying that the device met relevant performance standards, but the specifics are not provided.

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

• Sample Size: Not applicable/Not provided. This document describes a 510(k) submission, not a clinical study with a "test set" in the context of algorithm performance. The "testing" referred to is primarily mechanical testing for the physical device.
• Data Provenance: Not applicable.

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

• Not applicable. This is not an AI/algorithm-focused study requiring expert-established ground truth on a test set.

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:

• Not applicable. This is not an AI/algorithm study.

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

• Not applicable. This is a physical medical device (pedicle screw system), not an algorithm.

7. The type of ground truth used:

• Mechanical Testing: For the mechanical aspects, the "ground truth" would be established by validated test methods and established engineering standards for orthopedic implants.
• Substantial Equivalence: For the regulatory aspect, the "ground truth" is the performance and indications for use of the predicate device (SpheRx® II System), against which the new device is compared.
• Clinical Efficacy (Indirect): While no clinical studies were performed for this specific submission (as stated in Section H, "Summary of Clinical Tests (Not Applicable)"), the claim of substantial equivalence implies that the predicate device's clinical efficacy and safety data are being leveraged. The "ground truth" for the predicate device would have been established through clinical trials and post-market surveillance.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI study that uses a "training set."

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

• Not applicable.

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When used as a pedicle screw fixation system, the NuVasive SpheRx 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:

• Degenerative disc disease (as defined by back pain of discogenic origin with 1. degeneration of the disc confirmed by patient history and radiographic studies)
• Degenerative spondylolisthesis with objective evidence of neurologic impairment 2.
• Fracture 3.
• 4. Dislocation
• 5. Scoliosis
• 6. Kyphosis
• Spinal tumor and/or 7.
• Failed previous fusion (pseudoarthrosis) 8.

The NuVasive SpheRx 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)
• Spinal stenosis 2.
• Spondylolisthesis 3.
• 4. Spinal deformities
• 5. Fracture
• Pseudoarthosis 6.
• Tumor resection and/or 7.
• Failed previous fusion 8.

The NuVasive SpheRx System consists of a variety of polyaxial screws, fixed angle screws, 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 appears to be a 510(k) summary for a medical device (NuVasive SpheRx System) that is a pedicle screw system, not an AI/ML device. Therefore, the concepts of acceptance criteria, test sets, ground truth, experts, and training sets in the context of an AI/ML study do not directly apply to this document.

The "studies" presented here are non-clinical mechanical tests to demonstrate the structural integrity and performance of the physical implants. The "acceptance criteria" are implied by the successful completion and presentation of these mechanical tests, indicating the device meets established standards for strength, durability, and biocompatibility for spinal implants.

Here's an attempt to interpret your request in the context of the provided document, noting the fundamental difference in the type of device:

Since the provided document is a 510(k) summary for a pedicle screw system (physical implant) and not an AI/ML device, the concepts of acceptance criteria, test sets, ground truth, experts, and training sets as they relate to AI/ML performance are not applicable. The device's performance is assessed through mechanical and material testing, not through algorithmic evaluation on medical images or data.

Therefore, the following information cannot be extracted from the document:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample size used for the test set and data provenance for an AI/ML model.
• Number of experts used to establish ground truth and their qualifications for an AI/ML model.
• Adjudication method for an AI/ML model.
• Multi-reader multi-case (MRMC) comparative effectiveness study and effect size for an AI/ML model.
• Standalone (algorithm only) performance for an AI/ML model.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML model.
• Sample size for the training set for an AI/ML model.
• How the ground truth for the training set was established for an AI/ML model.

What can be inferred from the document regarding "acceptance" for this physical device:

The "acceptance criteria" for the NuVasive SpheRx System as described in this 510(k) would revolve around its substantial equivalence to a predicate device and the successful completion of non-clinical mechanical tests.

1. Acceptance Criteria and Device Performance (Interpreted for a Physical Device):

2. Study Proving Acceptance Criteria (Non-Clinical Mechanical Tests):

• Sample size for the test set: Not explicitly stated in this summary. Mechanical tests typically involve multiple samples of components and assembled constructs.
• Data provenance: Not applicable in the geopolitical sense. These are laboratory-generated results from physical testing of device components.
• Number of experts used to establish ground truth: Not applicable. Material and mechanical properties are assessed against engineering standards and specifications.
• Adjudication method: Not applicable. Mechanical test results are quantitative measurements against predefined thresholds.
• MRMC study: Not applicable for a physical implant.
• Standalone performance: The "standalone" performance refers to the device's mechanical integrity as tested in a lab setting, independent of human interaction during testing, but this term is typically used for AI/ML.
• Type of ground truth: Engineering specifications, material properties standards (e.g., ISO, ASTM), and performance data of the predicate device.
• Sample size for the training set: Not applicable (no "training set" for physical implants in this context).
• How the ground truth for the training set was established: Not applicable.

In summary, this document describes a traditional medical device (implantable hardware) clearance process, not the evaluation of an AI/ML medical device. Therefore, the specific questions about AI/ML performance metrics cannot be answered from the provided text.

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