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The NuVasive Reline Cervical System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Reline Cervical System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Reline Cervical System may be connected to the Nu Vasive® SpheRx® Spinal System, Precept® Spinal System, Armada® Spinal System and Reline® 4.5-5.0 System via the rod to rod connectors or transition rods.

The NuVasive Reline Cervical System is an occipito-cervico-thoracic posterior system manufactured from Titanium alloy (Ti6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3 and Cobalt Chromium alloy conforming to ASTM F90 or ASTM F1537. The Reline Cervical System consists of a variety of components including screws, rods, offset connectors, rod to rod connectors, set screws, cross connectors, hooks, eyelets, and occipital plates which can be rigidly locked in a variety of configurations to accommodate patient anatomy.

The NuVasive® Reline® Cervical System is a medical device designed to provide immobilization of spinal segments as an adjunct to fusion for various spinal instabilities. The device's acceptance criteria and the study proving it meets these criteria are detailed below based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing conducted to demonstrate substantial equivalence to a predicate device. While explicit numerical acceptance criteria values are not given, the overall criterion is that the subject device performs equivalently to the predicate device in specific mechanical tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each of the mechanical tests (Static and dynamic compression bending, static torsion, dynamic torsion, static tulip pull-off). The data provenance is non-clinical testing, implying in-vitro mechanical testing rather than patient data. Thus, there is no country of origin or retrospective/prospective classification applicable in this context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This section is not applicable as the device is a mechanical implant and the testing described is non-clinical mechanical performance testing. Ground truth for such tests is typically established through adherence to industry standards (like ASTM F2706 mentioned) and engineering specifications, not expert medical consensus.

4. Adjudication Method for the Test Set

This is not applicable to the non-clinical mechanical testing described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned in the document. The studies conducted were non-clinical mechanical performance tests.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a physical spinal implant, not an algorithm or AI-driven system.

7. Type of Ground Truth Used

The ground truth for the performance testing was based on mechanical performance standards and specifications, specifically ASTM F2706 and potentially other internal engineering acceptance criteria to demonstrate substantial equivalence to the predicate device.

8. Sample Size for the Training Set

This is not applicable. The device is a mechanical implant, not an AI or machine learning system that requires a training set. The testing performed was non-clinical mechanical performance testing.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated in point 8.

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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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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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