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 NuVasive SpheRx Spinal System, Precept Spinal System, Armada Spinal System, Reline 4.5-5.0 System va 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 provided text is a 510(k) summary for the NuVasive Reline Cervical System. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study that proves the device meets such criteria in the context of diagnostic or AI-augmented medical imaging.

Instead, this document details the regulatory approval process for a spinal implant system by demonstrating its substantial equivalence to previously cleared predicate devices. The "performance data" mentioned refers to non-clinical mechanical testing of the implant's strength and durability, not diagnostic accuracy or clinical outcomes in human subjects in the way an AI medical device would be evaluated.

Therefore, I cannot extract the information required for your request from this document. The questions you've asked are typically relevant to the evaluation of AI/ML-based medical devices or diagnostic tools.

To answer your request, I would need a document describing the evaluation of a diagnostic device or an AI-based system.

Ask a specific question about this device

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 NuVasive 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 provided text describes a 510(k) premarket notification for the NuVasive® Reline® Cervical System, a spinal implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices through material and mechanical performance testing, rather than a study involving human or image-based AI performance.

Therefore, the document does not contain the information required to answer questions 1-9 regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI or diagnostic performance.

The performance data section (G) specifically mentions:

• Nonclinical testing was performed to demonstrate that the subject NuVasive Reline Cervical System is substantially equivalent to the predicate device.
• The following testing was performed:
  • Dynamic Compression Bending per ASTM F1717
  • Static Torsion per ASTM F1717
  • Static My per ASTM F1798
  • Static Fz per ASTM F1798
• The results demonstrate that the subject NuVasive Reline Cervical System is substantially equivalent to the predicate.

This indicates mechanical testing of the physical implant components against established ASTM standards for spinal implants, not a clinical study on diagnostic accuracy or AI performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth was established, as this information is not present in the provided text.

Ask a specific question about this device