(27 days)
The C-TEK C-Thru Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.
The C-TEK C-Thru Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws manufactured from surgical implant grade titanium alloy as described by ASTM F 136 (Ti 6Al 4V ELI). The plates are provided in a fixed hole or slotted hole design and are available in 1 to 5 level plates. The screws are supplied color coded to identify their respective lengths. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) summary for the C-TEK C-Thru Anterior Cervical Plate System, detailing its classification, predicate device, indications for use, and a comparison to the predicate device. The document states that the device is considered substantially equivalent to a legally marketed predicate device based on similar indications, intended use, materials, and equivalent biomechanical performance.
Therefore, I cannot provide the requested information in the format of a table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies. This type of information is typically found in performance studies, clinical trials, or validation reports, which are not present in the provided 510(k) summary.
§ 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.