(76 days)
The CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.
The CervAlign Anterior Cervical Plate System is designed to promote cervical fusion by providing temporary resistance to flexion, extension, lateral bending, and axial rotation with strength and stiffness in the cervical spine (C2-C7). The system includes implants of various sizes of screws and plates to accommodate varying patient anatomies. The plates have integrated cover-style locking mechanisms that actuate to cover each screw. Implants are manufactured from titanium alloy, Ti-6Al-4V ELI instrumentation necessary to facilitate the insertion and removal. The implants and instruments are provided non-sterile and must be sterilized before use. Sterilization cases and trays are provided to facilitate proper sterilization and storage.
The provided text describes a medical device, the CervAlign™ Anterior Cervical Plate System, and its regulatory clearance. However, it does not contain the specific information requested regarding AI/CADe device acceptance criteria or related studies. The document is a 510(k) summary for a physical orthopedic implant, not an AI-powered diagnostic or assistive device. Therefore, I cannot provide the details about acceptance criteria, clinical study specifics, ground truth establishment, or sample sizes in the context of AI/CADe devices based on this input.
The document discusses non-clinical mechanical testing and MR safety evaluations to demonstrate substantial equivalence to predicate devices, which is typical for physical implants.
If you have a document related to an AI/CADe device, please provide that, and I will be happy to extract the requested information.
§ 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.