(63 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in static compression bending | Demonstrated substantial equivalence to predicate |
| Substantial equivalence to predicate device in dynamic compression bending | Demonstrated substantial equivalence to predicate |
| Substantial equivalence to predicate device in static torsion | Demonstrated substantial equivalence to predicate |
| Substantial equivalence to predicate device in static tulip pull-off | Demonstrated substantial equivalence to predicate |
| Substantial equivalence to predicate device in dynamic torsion | Demonstrated substantial equivalence to predicate |
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.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are 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.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.