(212 days)
The CYGNUS™ MoRe Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization of the anterior spine during the development of cervical spine fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain with degeneration of disc confirmed by patient history and radiographic studies); (2) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis); (6) Tumors: (7) Pseudoarthrosis: (8) Failed previous fusions.
The CYGNUS™ MoRe Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis used to provide structural stability following anterior cervical discectomy and fusion for cervical degenerative disorders. The CYGNUS™ MoRe Anterior Cervical Plate System consists of implants manufactured from Wrought Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, Titanium-6 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The system is offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.
The provided text is a 510(k) summary for the CYGNUS™ MoRe Anterior Cervical Plate System. It describes the device, its intended use, and comparisons to predicate devices. However, this document does not include information about AI/ML models, image analysis, or any study involving "device performance" in terms of diagnostic accuracy, sensitivity, specificity, or human-AI collaboration.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader studies. All the points in your request are relevant to AI/ML device submissions, which this document is not.
The document focuses on the mechanical and material performance of an orthopedic implant (spinal plate system) as per FDA guidelines for such devices. The "performance data" section only lists mechanical testing (e.g., static and dynamic compression bending, torsion testing) and bacterial endotoxin testing, which are standard for implantable medical devices to demonstrate structural integrity and biocompatibility.
In summary, this document does not contain the information needed to address your specific questions about AI/ML device performance or studies.
§ 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.