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K Number
K964533
Device Name
EBI SPINELINK SYSTEM
Manufacturer
ELECTRO-BIOLOGY, INC.
Date Cleared
1997-04-09

(148 days)

Product Code
MNH
Regulation Number
888.3070
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The EBI SpineLink™ System (severe spondylolisthesis indication) is intended for patient: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) 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 screws of the system are limited to L3- S1 or iliac screw fixation.

Device Description

The EBI SpineLink™ System is a posterior pedicle system 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 focuses on establishing substantial equivalence to predicate devices and describes the device, its intended use, and materials.

It does not contain the information necessary to describe acceptance criteria and a study proving a device meets those criteria in the context of an AI/algorithm-based medical device.

The document describes a mechanical spinal fixation system, not an AI or algorithm-based device. Therefore, typical metrics like "device performance" (e.g., sensitivity, specificity, accuracy), sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone performance for AI are not applicable or discussed here.

The "study" mentioned is "Bench testing comparing the system to a predicate system demonstrated that the device complies with applicable standards and meets all of its functional requirements." This refers to biomechanical testing, not clinical performance or AI algorithm validation.

Therefore, I cannot fulfill your request based on the provided input.

To answer your question, I would need a document related to an AI or algorithm-based medical device that includes:

  • Specific performance metrics (e.g., accuracy, sensitivity, specificity, F1-score).
  • Defined acceptance criteria for these metrics.
  • Details of a clinical or analytical validation study (including sample size, data provenance, ground truth methodology, expert qualifications, etc.).

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Image /page/0/Picture/3 description: The image shows the logo for EBI Electro Biology. The letters "EBI" are in a large, bold, sans-serif font, with the word "Electro" above the word "Biology" in a smaller, serif font. There are horizontal lines above and below the entire logo.

through Applied Science

Enhancing Bone Healing

APR - 9 1997

K964533

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 4, 1997

    1. Proprietary Name: EBI SpineLink™ System Posterior pedicle spinal system Common Name: Classification Name:Spondylolisthesis Spinal Fixation Device System (Proposed)
    1. 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
    • · VSP® Plating System AcroMed Corporation
    • · KSF Spinal Fixator Tornier SA
    1. Description of the device: The EBI SpineLink™ System is a posterior pedicle system 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 (severe spondylolisthesis indication) is intended for patient: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) 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 screws of the system are limited to L3- S1 or iliac screw fixation.

    1. Materials: The components of the system are manufactured from Ti-SAI-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 sulement made in conjunction with this submission of subseanial equivalence to any other product is intended only Io relate to whether the product can be lawfully market approval or reclassification and is not intended to be interpreted as an idmission or any other you of crident infringement liggstion . [Esablishment Registration and Permsiter Notices Frink Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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