(154 days)
The EBI SpineLink™ System, a spinal fixation device for the noncervical spine, is indicated for (a) anterior fixation, (b) posterior hook and sacral/iliac screw fixation and ® pedicle screw fixation.
When used as an anterior fixation system or as a posterior hook and sacral/iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracic, lumbar and sacral segments of the spine, in cases of degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.
When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only, ® who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The system are limited to L3- S1 or iliac screw fixation with the fusion only at L5-S1.
The EBI SpineLink™ System is a spinal fixation device for the noncervical spine consisting of fixed and polydirectional pedicle/sacral screws (available in diameters from 5,5 to 7.5 mm), various types of interconnecting links, lock nuts, and different types of washers.
The provided text is a 510(k) Summary of Safety & Effectiveness for the EBI SpineLink™ System. This document describes a medical device (a spinal fixation system) and compares it to predicate devices. It focuses on intended use, materials, and technological characteristics to establish substantial equivalence.
However, the text does not contain any information about acceptance criteria or a study that evaluates an AI/ML device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide the detailed table and information points you asked for, as the provided input does not relate to an AI/ML device.
§ 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.