(44 days)
This system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (i.e., fractures or dislocation), 3) tumors, 4) spinal stenosis, 5) spondylolisthesis, 6)deformity or curvatures (i.e., kyphosis and/or lordosis, or scoliosis), 7) pseudoarthrosis, and/or 8) failed previous fusions.
The Verteview Anterior Cervical Plate System is a fixation device consisting of a variety of sizes of cervical plates, locking tabs, fixed and variable angle bone screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The screws have various diameters. All components are supplied clean not sterile.
The Verteview Anterior Cervical Plate System implant components are made from titanium alloy Ti-6Al-4V ELI and are surface treated with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter.
The provided text is a 510(k) Premarket Notification Submission for the Verteview Anterior Cervical Plate System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth, expert opinions, or sample sizes for testing or training sets.
Therefore, I cannot provide the requested information in a table format or answer the specific questions related to acceptance criteria and studies, as this information is not present in the provided document.
The document focuses on demonstrating substantial equivalence through a comparison to a predicate device and refers to testing conducted in accordance with ASTM F1717-04 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This ASTM standard outlines mechanical testing methods for spinal implants, primarily to assess their structural integrity and strength, rather than to establish clinical acceptance criteria or evaluate human-in-the-loop performance.
In summary, the provided document does not contain the information needed to address your request.
§ 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.