(76 days)
The NuVasive Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is to provide immobilization and stabilization of cervical 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 cervical spine: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusions, and/or spinal stenosis.
The NuVasive Anterior Cervical Plate System consists of a variety of plates and screws. 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) premarket notification describes a mechanical spinal implant, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria, study data provenance, expert ground truth, MRMC studies, standalone performance, training set details, and ground truth establishment methods are not applicable.
The submission focuses on demonstrating substantial equivalence to predicate devices through engineering drawings, labeling, and mechanical testing.
Summary of Non-Clinical Tests:
- Mechanical testing was presented. (K041447 py (1/2), Section G)
Summary of Clinical Tests:
- (Not Applicable) (K041447 py (1/2), Section H)
Since this document pertains to a physical medical device and not a software algorithm, the specific criteria for AI/ML performance evaluation (such as sensitivity, specificity, or AUC) are not relevant here.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.