(55 days)
The VyPlate™ Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:
- instability caused by trauma or fracture;
- instability associated with correction of cervical lordosis and kyphosis deformity; ●
- instability associated with pseudoarthosis as a result of previously failed cervical spine surgery:
- instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine;
- . instability associated with single or multiple level corpectomy in advanced degenerative disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.
This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The VyPlate™ Anterior Cervical Plate System is comprised of implant, instrument, and tray components. The implant components, the VyPlate™ device, consists of anterior cervical plates, cover plates, and bone screws. The implant components of the VyPlate™ Anterior Cervical Plate System are composed of Titanium alloy 6A1-4V as described in ASTM F-136.
The provided text is a 510(k) summary for the VyPlate™ Anterior Cervical Plate System. It describes the device, its intended use, and its substantial equivalence to a predicate device.
However, the document does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/algorithm-driven medical device. The document is purely for a traditional medical device (a spinal plate system), and the criteria you're asking about (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone algorithm performance) are specific to the validation of AI/ML-based medical devices.
Therefore, I cannot extract the requested information from the provided text. The device described is a physical implant, not an AI/ML algorithm.
§ 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.