EBI SPINELINK SYSTEM by ELECTRO-BIOLOGY, INC.

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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Electro Biology Inc. The logo consists of the letters "EBI" in a large, bold font, with the words "Electro Biology" in a smaller font to the right of the letters. The word "Electro" is above the word "Biology". There are horizontal lines above and below the letters "EBI".

2 1997

Inhancing Bone Healing through Applied Science

510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI SpineLink™ System is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.

1. Submitter: Electro-Biology, Inc. 6 Upper Pond Road Parsippany, NJ 07054
  Contact Person: Jon Caparotta Telephone: (201) 299-9022

Date prepared: April 23, 1997

1. Proprietary Name: Common Name: Classification Names:
  EBI SpineLink™ System Spinal Fixation System for the Noncervical Spine Spondylolisthesis Spinal Fixation Device System (Proposed) Spinal Intervertebral Body Fixation Orthosis Spinal Interlaminal Fixation Orthosis

3. Predicate or legally marketed devices that are substantially equivalent:

Webb-Morley Spine System Electro-Biology, Inc.
TSRH® Spinal System Sofamor Danek
Dyna-Lok® Spine System Sofamor Danek
Isola® Spine System AcroMed Corporation
· KSF Spinal Fixator Tornier SA
· VSP® Plating System AcroMed Corporation
1. Description of the device: 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.
Intended Use: The EBI SpineLink™ System, a spinal fixation device for the noncervical spine, is 5. indicated for (a) anterior fixation, (b) posterior hook and sacral/iliac screw fixation and ® pedicle screw fixation.

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1. Materials: The components of the system are manufactured from Ti-6Al-4V ELI per ASTM F136, The components will be available with and without TiN coating.
1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between EBI SpineLink™ System and other currently marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function. Bench testing comparing the system to a predicate system demonstrated that the device complies with applicable standards and meets all of its functional requirements.

* Any statement made in conjunction regarding a decemination of substanial equivalence to any other product is intended only to relate to whether the product can be lawfully market approval or reclassification and is not intended to be interpred as an admission or any other type of evidence in patent infringement lifeastion and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.))

Regulation Number and Section

§ 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.