Search Results

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.

Ask a specific question about this device

When used as a pedicle screw fixation system, the NuVasive® 4.5-5.0 System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion 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 Reline 4.5-5.0 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 Reline 4.5-5.0 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 When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline 4.5-5.0 System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the NuVasive Reline 4.5-5.0 System is intended to treat pediatic patients diagnosed with the following conditions: spondylolysis, and fracture caused by turnor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft. In order to achieve additional levels of fixation, the NuVasive Reline 4.5-5.0 System rods may be connected to the Reline System.

The NuVasive Reline 4.5-5.0 System is a pedicle screw system that consists of a varietv 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 configurations to suit the individual pathology and anatomical conditions of the patient.

This document is a 510(k) premarket notification for the NuVasive Reline 4.5-5.0 System, a pedicle screw system. It states that the device is substantially equivalent to legally marketed predicate devices. The information provided focuses on demonstrating this equivalence through non-clinical performance testing rather than clinical studies or AI-driven performance.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document confirms that "demonstrate that the subject NuVasive Reline 4.5-5.0 System is substantially equivalent to the predicate device." However, it does not provide specific numerical values for the acceptance criteria (e.g., minimum bending strength in Nm) or the numerical performance results of the NuVasive Reline 4.5-5.0 System or its predicate for direct comparison. It only states that the results show substantial equivalence.

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

The study described is non-clinical performance testing of a physical medical device (pedicle screw system), not an AI/software device involving data sets, patients, or human readers. Therefore:

• Sample Size for Test Set: This information is not provided as the tests are for mechanical properties of the device components. The ASTM standards typically specify the number of samples required for each test.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this involves mechanical testing of physical implants, not patient data.

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

Not applicable. Ground truth, in the context of expert consensus, is relevant for AI/diagnostic devices interpreting medical images or patient data. This is a physical device subject to mechanical engineering standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. Adjudication methods are used to resolve disagreements among human experts in clinical studies, not for non-clinical mechanical testing.

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 document describes the testing of a physical medical implant (pedicle screw system), not an AI device.

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 document focuses on the mechanical properties and substantial equivalence of a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this type of device is defined by the ASTM standards (ASTM F1717 and ASTM F1798) themselves, which specify the test methodologies and, implicitly, the expected performance characteristics for pedicle screw systems. Substantial equivalence is determined by comparing the new device's performance to that of a legally marketed predicate device under these standardized test conditions.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence of a physical medical device.

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

Not applicable. As there's no training set, there's no ground truth for it to be established.

Ask a specific question about this device