(31 days)
The Reliance 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 Reliance Anterior Cervical Plate System device is intended to be used as an anterior cervical plate device. The Reliance Anterior Cervical Plate System is comprised of implant and instrument components. The Reliance Anterior Cervical Plate implant device is manufactured from Titanium alloy as specified by ASTM F-136. The Reliance Anterior Cervical Plate is a combination of the plate, cover plate, set screw, and bone screw components. The cover plate is attached to the plate by means of the set screw.
The provided text describes the 510(k) submission for the Reliance Anterior Cervical Plate System. However, it does not contain any information regarding a study involving artificial intelligence (AI) or a specific AI device.
Instead, the document details a mechanical device (an anterior cervical plate system) and its substantial equivalence to a predicate device based on:
- Mechanical Testing: Performed according to ASTM F-1717 (static compression bending, static torsion, and dynamic compression bending).
- Sterilization and Biocompatibility.
- Risk Analysis.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI device meets its acceptance criteria using the provided input, as the input clearly pertains to a medical implant (hardware) and not an AI-driven software or device.
The questions regarding AI performance criteria, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, AI training sets, and their ground truth methods are not applicable to this document.
§ 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.