EBI ESL SPINE SPACER SYSTEM by EBI, L.P.

The EBI ESL Spine Spacer System is intended for use in the thoracolumbar spine (i.e., T l to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The EBI ESL Spinc Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI ESL Spinc Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged time. The system must be used in conjunction with the EBI NGC Spinal System, EBI Omega 21 Spinal System or the EBI SpineLink II Spinal System.

Device Description

The ESL Spine Spacer is an endplate sparing vertebral body replacement device. The superior and inferior ends are arranged in a convex shape to toolir on the supe of the vertebral endplate. The device is open in the transverse plane to allow the surgeon to pack the device with bone graft prior to insertion. There transverse plane to anow the bateral direction to allow for more bone growth through the all also nors through the medial lateral are available in order to connect two devices within the vertebral space.

AI/ML Overview

The provided 510(k) summary for the EBI ESL Spine Spacer System does not contain details about acceptance criteria, device performance tables, or a study report in the format typically used for AI/ML device evaluations. This document is related to a spinal implant and focuses on mechanical testing and substantial equivalence to predicate devices, rather than a performance study of software or an AI algorithm.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable / Not found in the provided document. The document states "Mechanical testing comparing the EBI devices in regards to intended use, materials and function. Mechanical testing... demonstrated that the device complies with applicable standards and guidelines and meets all of its functional requirements." However, no specific performance metrics or acceptance criteria are listed.

2. Sample Size for the Test Set and Data Provenance

Not applicable / Not found in the provided document. This information is typically relevant for studies involving data-driven devices or AI. For this spinal implant, "testing" likely refers to benchtop mechanical tests rather than a clinical dataset.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable / Not found in the provided document. This type of expert review is not mentioned as part of the approval process described.

4. Adjudication Method for the Test Set

Not applicable / Not found in the provided document. This is relevant for studies requiring expert consensus, not for mechanical testing of an inert implant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable / Not found in the provided document. This type of study would compare human performance with and without AI assistance, which is not relevant for this device.

6. Standalone (Algorithm Only) Performance Study

Not applicable / Not found in the provided document. This device is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used

Not applicable / Not found in the provided document. No "ground truth" as understood in expert-reviewed data studies is mentioned. The "truth" for this device would be its mechanical properties and biocompatibility.

8. Sample Size for the Training Set

Not applicable / Not found in the provided document. This pertains to AI/ML model development, which is not relevant here.

9. How the Ground Truth for the Training Set Was Established

Not applicable / Not found in the provided document. This pertains to AI/ML model development, which is not relevant here.

Summary of Device-Specific Information from the Document:

Device Name: EBI ESL Spine Spacer System
Intended Use: To replace a diseased vertebral body (T1 to L5) resected for tumors, achieve anterior decompression, and restore height of a collapsed vertebral body. Also indicated for treating thoracic and lumbar spine fractures. Designed to restore biomechanical integrity.
Materials: Titanium, Ti-6Al-4V ELI, per ASTM F136.
Predicate Devices: EBI Ionic Spine Spacer System (K020887), Synthes Vertebral Spacer Ti (K024364).
Study/Evidence Provided: "Mechanical testing comparing the EBI devices in regards to intended use, materials and function. Mechanical testing... demonstrated that the device complies with applicable standards and guidelines and meets all of its functional requirements." This indicates bench testing was performed to demonstrate substantial equivalence to predicate devices, focusing on the mechanical properties and function expected of a spinal implant.
Approval Date: April 16, 2004.

Summary

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K040482

APR 1 6 2004

510(k) Summary

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

1. Submitter: Jon Caparotta, RAC Manager Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
  Contact Person: Frederic Testa, RAC Telephone: 973-299-9300 Fax: 973-257-0232

Date prepared: February 23, 2004

	2. Proprietary Name:	EBI ESL Spine Spacer System
	Common Name:	Spinal Fixation Device
	Classification Name/Code:	Spinal Vertebral Body Replacement Device/MQI

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

EB1 Ionic Spine Spacer System (K020887) ◆
Synthes Vertebral Spacer Ti (K024364) .
Description of the device: The ESL Spine Spacer is an endplate sparing vertebral body 4. Description of the device. The superior and inferior ends are arranged in a convex shape to replacement device. The toolir on the supe of the vertebral endplate. The device is open in the transverse plane to allow the surgeon to pack the device with bone graft prior to insertion. There transverse plane to anow the bateral direction to allow for more bone growth through the all also nors through the medial lateral are available in order to connect two devices within the vertebral space.
Intended Use: The EBI ESL Spine Spacer System is intended for use in the thoracolumbar spine ડાં (i.e., TI to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors (1.6., 11 to 23) to repears a decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The EBI ESL Spine Spacer System is also indicated for neight of a conapsed verteorar 003). The EBI ESI. Spine Spacer System is designed treating the biomechanical integrity of the anterior, middle, and posterior spinal column even in to resort the fionieonamour meether the The system must be used in conjunction with the FBI the absence of rashon for a preceilg. Spinal System or the EBI SpineLink II Spinal System.
Materials: The ESL Spinc Spacer System is manufactured from Titanium, Ti-6Al-4V ELI, per 6. ASTM F136.

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1. Comparison of the technological characteristics of the device to predicate devices: There are Comparison of the technological character in the Spacer System and other currently marketed the stgmineam unferences occircon the Der System is substantially equivalent* to the predicate spires in regards to intended use, materials and function. Mechanical testing comparing the EBI devices in regards to intended ass, include system demonstrated that the device complies with applicable standards and guidelines and meets all of its functional requirements.

Any statement made in conjunction with this submission regarding a determination of substantial equivalence to * Any statement made in conjunction whilt ans submission regal ang a whilly marketed without pre-market any other product is intended only to relate to thems the peted as an admission or any other type of evidence in approval of reclassification and Is not thement Registration and Premarket Notification Procedures, Final patcht unringement migarrust 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2004

Frederic Testa, RAC Senior Regulatory Affairs Specialist EBI L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K040482

Trade/Device Name: EBI ESL Spine Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: February 23, 2004 Received: February 25, 2004

Dear Mr. Testa:

We have reviewed your Scction 510(k) premarket notification of intent to market the device we nave reviewed your by determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, do reces that have over require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of general voltable provision practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your de rice to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Frederic Testa, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yours finding of substantial equivalence of your device to a legally premative hodicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrice for Jour 301) 594-4659. Also, please note the regulation entitled, Connact the Office of Companies notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour Cossumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark McMillan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known): K040482

Device Name: EBI ESL Spine Spacer System

Indications For Use:

The EBI ESL Spine Spacer System is intended for use in the thoracolumbar spine (i.e., T l to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The EBI ESL Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI ESL Spinc Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged time. The system must be used in conjunction with the EBI NGC Spinal System, EBI Omega 21 Spinal System or the EBI SpineLink II Spinal System.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

X
rescription Use

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Dush M. Mllker

Division of General, Restorative, and Neurological D

5 K040482

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.