(96 days)
The EZ Plate™ cervical plate system is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
The EZ Plate™ cervical plate system consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.
The provided document is a 510(k) premarket notification for a medical device called the "EZ Plate™ cervical plate system." It describes the device, its intended use, materials, and provides a comparison to predicate devices. However, this document does not contain information about a study involving AI or software for diagnostic purposes, nor does it provide acceptance criteria or performance data for such a study.
The "Performance Data" section in the document refers to mechanical testing (static compression bending, torsion, and dynamic compression bending) performed according to ASTM F1717. This testing is for the physical device (cervical plate system) to demonstrate its mechanical properties and equivalence to predicate devices, not for evaluating software or AI performance in a diagnostic or clinical setting.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device (AI/software) meets those criteria based on the provided text. The document is about a physically implanted medical device, not a diagnostic AI system.
§ 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.