(52 days)
The Curiteva Midline Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-T1) as an adjunct to fusion. The system is intended to provide temporary stabilization during the development of cervical spinal fusion in patients with the following: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformity (e.g., kyphosis, scoliosis), tumors, pseudarthrosis, and/or failed previous fusion.
The Curiteva Midline Anterior Cervical Plate System consists of screws and plates. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy. All implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136 and are provided non-sterile.
The provided text is a 510(k) summary for the Curiteva Midline Anterior Cervical Plate System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical performance data. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, particular performance metrics, details of a study that proves the device meets those criteria, sample sizes for test/training sets, expert qualifications, or details about comparative effectiveness studies (MRMC or standalone AI performance).
Therefore, I cannot fulfill the request as the essential information is not present in the provided document.
A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through mechanical testing for implantable devices like the one described. It typically does not involve clinical studies with human readers or AI algorithms in the way the prompt's questions suggest.
§ 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.