(86 days)
The EBI Anterior Cervical Spine System is a single use device, intended for anterior cervical spine applications only Specific indications include the fusion, reduction, alignment or stabilization of the cervical segments of the spine in cases of degenerative disc disease (spondylosis of the cervical spine, cervical spondylotic myelopathy and cervical spondylosis neuropathy), trauma, and tumors.
The EBI Anterior Cervical Spine System consists of spinal implant components and various instruments used during the implantation procedure. The spinal implants consist of plates, screws and locking screws. Materials: Ti-6AI-4V ELI alloy with or without Titanium nitride coating
I apologize, but the provided text does not contain information about acceptance criteria or a study proving device performance as requested in your prompt. The text is a "Summary of Safety & Effectiveness for EBI Anterior Cervical Spine System," which describes a medical device, its intended use, and its comparison to predicate devices, focusing on the addition of a Titanium nitride (TiN) coating.
Therefore, I cannot fulfill your request for the tables and details about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on the given input.
§ 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.