MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM by EBI, L.P.

The EBI VueLock™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

Device Description

The EBI VueLock™ Anterior Cervical Plate System is a cervical spinal fixation device of plates and screws. The plates contain a locking ring mechanism, which locks the screws into place. The plates are designed to span between one and four levels, and are manufactured from titanium. This submission is for the addition of Self Drilling Screws to the System.

AI/ML Overview

The provided text describes a 510(k) summary for the EBI VueLock™ Anterior Cervical Plate System. This is a medical device for spinal fixation, and the document focuses on regulatory approval rather than a clinical study evaluating AI performance. Therefore, most of the requested information about acceptance criteria, study sizes, expert involvement, and AI-specific metrics is not present in the provided text.

However, based on the information available, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Functional Requirements	"The mechanical testing demonstrated that the device complies with applicable standards and meets all of its functional requirements."
Compliance with Applicable Standards	"The mechanical testing demonstrated that the device complies with applicable standards..."
Substantial Equivalence to Predicate Devices (Intended Use, Materials, Function)	"It is substantially equivalent to the predicate devices in regards to intended use, materials and function."

2. Sample size used for the test set and the data provenance:

Not Applicable. The submission primarily discusses mechanical testing and a comparison to predicate devices, not testing on human subjects for AI performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This information is for AI performance evaluations, which are not detailed here.

4. Adjudication method for the test set:

Not Applicable. This information is for AI performance evaluations, which are not detailed here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. The document does not mention any MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. The document does not describe any standalone algorithm performance.

7. The type of ground truth used:

Mechanical Testing Results and Predicate Device Characteristics: The "ground truth" for this submission appears to be the standards for mechanical performance and the characteristics of previously approved (predicate) spinal fixation devices.

8. The sample size for the training set:

Not Applicable. This document describes a medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

Not Applicable. See point 8.

Summary

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OCT 1 8 2002

023133
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510(k) Summary of Safety & Effectiveness

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

1. Submitter: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
  Contact Person: Frederic Testa, RAC Telephone: (973) 299-9300

September 19, 2002 Date prepared:

1. Proprietary Name: EBI VueLock™ Anterior Cervical Plate System Spinal Fixation Device Common Name: Classification Names: Spinal Intervertebral Body Fixation Orthosis
1. Predicate or legally marketed devices that are substantially equivalent: · EBI VueLock™ Anterior Cervical Plate System
1. Description of the device: The EBI VueLock™ Anterior Cervical Plate System is a cervical spinal fixation device of plates and screws. The plates contain a locking ring mechanism, which locks the screws into place. The plates are designed to span between one and four levels, and are manufactured from titanium. This submission is for the addition of Self Drilling Screws to the System.
1. Intended Use: The EBI VueLock™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

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K623133
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Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

1. Materials: The components of the system are manufactured from Ti-6Al-4V ELI per ASTM F136.
1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI VueLock™ Anterior Cervical Plate System and other currently marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function. The mechanical testing demonstrated that the device complies with applicable standards and meets all of its functional requirements.

* Any statement made in conjunction with this submission of substantial 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 interveted as an admission or any other type of evidence in patent inigation fistablishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 three human profiles facing to the right, arranged in a stacked, overlapping manner.

OCT 1 8 2002

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Mr. Frederic Testa, RAC EBI. L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K023133 Trade/Device Name: EBI® VueLock™ Anterior Cervical Plate Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: K WQ Dated: September 19, 2002 Received: September 20, 2002

Dear Mr. Testa;

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have 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, and Cosmetic Act (Act) that do not 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. Iisting of devices, good manufacturing 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 may be subject 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 does 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 - Mr. Frederic Testa, RAC

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 A Miller

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

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STATEMENT OF INDICATIONS FOR USE

Page 1 of 1

510(k) Number (if known): KOa 3/33

Device Name: EBI VueLock™ Anterior Cervical Plate System

Indications For Use:

WARNING: This device is not approved for screw attachment to the posterior elements

(pedicles) of the cervical, thoracic, or lumbar spine.

spine.

for

Mark A. Milleson

(Division Sign-
Division of Ger Restorative

්. Restorative and Neurological J

510(k) Number K023133

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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.