(96 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 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.
§ 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.