(83 days)
Indicated for use in anterior screw fixation to the cervical spine ( C2 - C7 ) for the following indications: degenerative disc disease ( DDD ), spondylolisthesis, trauma ( including fractures ), spinal stenosis and tumors ( primary and metastatic ), failed previous fusions (pseudarthrosis ) and deformity ( defined as scoliosis, kyphosis or lordosis ).
The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Materials: The devices are manufactured from Commercially Pure Titanium and titanium allov per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.
The provided text describes a medical device, the Pyrenees Cervical Plate System, and its regulatory clearance process, including an "Indications For Use" statement. However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample sizes, expert qualifications, adjudication methods, or ground truth establishment).
The document is a "Summary of Safety and Effectiveness" and a 510(k) clearance letter from the FDA. These documents primarily focus on demonstrating substantial equivalence to a predicate device based on design, function, material, and intended use, rather than presenting detailed performance study results against specific acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other study-related details based on the provided text. The text explicitly states: "There are no significant differences between the Pyrenees Cervical Plate System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use." This language indicates a reliance on substantial equivalence rather than a new performance study with explicit acceptance criteria.
§ 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.