(58 days)
The DeGen Medical Cyclops™ Anterior Cervical Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Cyclops™ Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indications:
- · Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Spinal Stenosis .
- Trauma (i.e. fracture or dislocation) .
- Deformity or curvatures (including scoliosis, kyphosis, or lordosis) .
- . Spinal Tumors
- Pseudoarthrosis or failed previous fusion .
- Spondylolisthesis .
- Decompression of the spinal following total or partial cervical vertebrectomy .
The DeGen Medical Cyclops™ Anterior Cervical Plate Systems (CACP) consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The CACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options. The system is provided non-sterile and is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
The provided text is a 510(k) summary for a medical device, the DeGen Medical Cyclops™ Anterior Cervical Plate System. It describes the device's intended use, technological characteristics, and non-clinical performance testing. However, this document does not contain information about an AI/ML-based medical device. Therefore, it is not possible to describe acceptance criteria or a study proving an AI/ML device meets those criteria from this text.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, function, and mechanical performance rather than clinical performance or AI algorithm assessment.
Therefore, I cannot fulfill the request as the core information regarding an AI/ML device's acceptance criteria, performance study details, ground truth establishment, or human-in-the-loop analysis is absent from the provided text.
§ 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.