The EBI® SpineLink™ Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. 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 SpineLink System is an anterior cervical spinal fixation device that uses interconnecting links. This submission is for the addition of a 3.5mm diameter screw to the existing System.

AI/ML Overview

This submission is a 510(k) Pre-market Notification for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to prove safety and effectiveness from scratch. Therefore, the information provided focuses on comparative performance rather than extensive standalone studies with detailed acceptance criteria and expert reviews as would be expected for novel devices or those undergoing PMA.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria (from text)	Reported Device Performance (from text)
Substantial Equivalence	To demonstrate substantial equivalence to predicate devices (K973923, K991092, K993822, K000513) in intended use, materials, and function.	"It is substantially equivalent to the predicate device in regards to intended use, materials, and function."
Mechanical Testing	Device must comply with "applicable standards" and meet "all of its functional requirements." (Specific standards and requirements are not detailed in this summary).	"Mechanical testing demonstrates that the device complies with applicable standards and meets all of its functional requirements."
Material Composition	System components manufactured from Ti-6Al-4V ELI.	"The components of the System are manufactured from Ti-6A1-4V ELI per ASTM F136."

Note: The 510(k) summary does not typically include a detailed list of quantitative acceptance criteria as would be present in a design verification and validation report. The primary acceptance criterion for a 510(k) is demonstrating substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a clinical "test set" in the context of human data. The "testing" mentioned is mechanical.

Sample size for mechanical testing: Not specified.
Data Provenance: The mechanical testing would have been conducted by the manufacturer, EBI, L.P. The location is Parsippany, NJ, USA. It's a laboratory-based test, not human-specific data, and would be considered prospective for the specific device modification.

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

This information is not provided in the 510(k) summary, as the nature of the submission (510(k) for a modification to an existing device) relies on mechanical testing and comparison to legally marketed predicates. There's no mention of a test set requiring expert ground truth establishment in this context.

4. Adjudication Method for the Test Set:

This information is not provided. Given the type of submission (510(k) for mechanical substantial equivalence), adjudication by multiple experts for a clinical test set is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. The document does not describe an MRMC study. This type of study is far more common for AI/imaging devices where human interpretation is a key component to be improved. This submission is for an orthopedic implant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was Done:

No. This question is not applicable. This is not an algorithm-based device. The "device" is a physical spinal fixation system. However, if one were to interpret "standalone performance" as the performance of the device itself (mechanical integrity, material properties), then the "Mechanical testing" mentioned would represent this.

7. The Type of Ground Truth Used:

For the mechanical testing, the "ground truth" would be the established engineering standards (e.g., ASTM F136 for materials) and internal design specifications for functional requirements. For the substantial equivalence argument, the "ground truth" is the established safety and effectiveness of the legally marketed predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of machine learning or AI algorithms, as this is a physical medical device.

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

This information is not applicable for the same reasons as #8.

Summary

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K022419 p1/2

AUG 1 2 2002

510(k) Summary

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

1. Submitter:	EBI, L.P.100 Interpace ParkwayParsippany, NJ 07054	Contact Person:	Frederic TestaTelephone: (973) 299-9300, ext. 2208
Date prepared:	July 23, 2002
2. Proprietary Name:	EBI SpineLink Anterior Cervical Spinal System
Common Name:	Spinal Fixation Device
Classification Names:	Spinal Intervertebral Body Fixation Orthosis

1. Predicate or legally marketed devices that are substantially equivalent:
- - EBI® SpineLink™ Anterior Cervical Spinal System (K973923, K991092, K993822, K000513)
1. Description of the device: The EBI SpineLink System is an anterior cervical spinal fixation device that uses interconnecting links. This submission is for the addition of a 3.5mm diameter screw to the existing System.
1. Intended Use: The EBI SpineLink Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. 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

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K022414 p²/₂

by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

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-6A1-4V ELI per ASTM F136.
1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the modified EBI SpineLink Anterior Cervical Spinal System and the currently marketed System. It is substantially equivalent* to the predicate device in regards to intended use, materials, and function. Mechanical testing demonstrates that the device complies with applicable standards and meets all of its functional requirements.

* Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment 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

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2002

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

Re: K022419

Trade/Device Name: EBI® Spinelink" Anterior Cervical Spinal System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: July 23, 2002 Received: July 24, 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, listing 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 H. Willeson

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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STATEMENT OF INDICATIONS FOR USE

Page of

510(k) Number (if known):

Device Name: EBI SpineLink™ Anterior Cervical Spinal System

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

(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)

Over-The-Counter Use

Mark A. Mckenna
Division Sign-Off

on of General. Restorative and scurological Devices 510(k) Number _

(Optional Format 1-2-96)

Regulation Number and Section

N/A