(73 days)
The Matira™ Anterior Cervical System is interior interbody screw fixation of the cervical spine from C2 to Tl. The system is indicated for use in the temporary stabilization of the anterior spine as an adjunct to fusion for patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures and dislocations), tumors, spondylolisthesis, deformity (defined as kyphosis, lordosis), spinal stenosis, pseudarthrosis, and/or failed previous fusions. This device system is intended for anterior cervical intervertebral body fusions only.
The Matira Anterior Cervical System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The Matira Anterior Cervical System consists of a variety of shapes and sizes of bone plates, screws (available in self-drilling or self-tapping, fixed or variable configurations), and associated instruments. Bone screws inserted into the vertebral body of the cervical spine using System implant components are made from titanium alloy.
This document is a 510(k) premarket notification for the Matira™ Anterior Cervical System. It does not contain information about an AI/ML device or its acceptance criteria and study data.
The document describes a medical device for spinal fixation and explicitly states under "Clinical Test Summary" that "No clinical studies were performed." Therefore, there is no information in this document to address your request regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any studies involving human readers or standalone algorithm performance.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (mechanical tests on plates and screws per ASTM standards) and similarities in intended use, design, materials, and technology.
§ 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.