The Z-Link Cervical is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Z-Link Cervical should be packed with autogenous bone graft and implanted with an anterior approach.

Device Description

The Zavation Z-Link Cervical includes a PEEK spacer, titanium interbody plate and screws. The spacer component is assembled to an interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes two holes for inserting one bone screw in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.

AI/ML Overview

The provided document describes the Zavation Z-Link Cervical, an intervertebral body fusion device, and its acceptance criteria as demonstrated by mechanical testing. However, it does not include information about a study involving an AI algorithm or human readers. The acceptance criteria and the study proving it relate directly to the physical properties and performance of the medical device itself.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance:	Demonstrated to be substantially equivalent to predicate devices.
- Static Axial Compression	Passed (implied by "substantially equivalent" and testing per ASTM F2077)
- Dynamic Axial Compression	Passed (implied by "substantially equivalent" and testing per ASTM F2077)
- Static Torsion	Passed (implied by "substantially equivalent" and testing per ASTM F2077)
- Dynamic Torsion	Passed (implied by "substantially equivalent" and testing per ASTM F2077)
- Load Induced Subsidence	Passed (implied by "substantially equivalent" and testing per ASTM F2267)
- Static Pushout	Passed (implied by "substantially equivalent" and testing per ASTM Draft F04.25.02.02)
Biocompatibility:	Materials (PEEK Zeniva ZA-500, Tantalum alloy, Titanium alloy) meet ASTM standards (Implied by stating use of medical grade materials adhering to specific ASTM standards, thus presumed biocompatible).

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

This information is not provided in the document. The document refers to "mechanical test results" but does not specify the number of devices or components tested. Data provenance is not applicable as this describes mechanical testing of a physical device, not analysis of human patient data.

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

This information is not applicable to the type of study described. The "ground truth" for this device's mechanical performance is established by standardized engineering tests (ASTM standards) rather than expert human interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Mechanical testing according to established ASTM standards does not involve adjudication by experts in the same way clinical or imaging studies might. The results are objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This document describes mechanical testing of a physical medical device, not a study involving human readers or AI.

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

No, a standalone algorithm study was not done. This document is about a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's acceptance is based on the results of standardized mechanical engineering tests (ASTM F2077, ASTM F2267, ASTM Draft F04.25.02.02). The device's performance must meet the requirements of these standards to be considered "substantially equivalent" to predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this document describes mechanical testing of a physical medical device, not an AI algorithm.

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

This information is not applicable. There is no "training set" or corresponding ground truth establishment described for an AI algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 7, 2014

Zavation, LLC Mr. John Walker Engineering Manager 400 Liberty Park Drive Flowood, Mississippi 39232

K141005 Re: Trade/Device Name: Zavation Z-Link Cervical Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: July 22, 2014 Received: July 24, 2014

Dear Mr. Walker:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Ronald & Nean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141005

Device Name Zavation Z-Link Cervical

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Anton E. Dmitriev, PhD

Division of Orthopedic Devices

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510K Summary

Date:	August 4, 2014
Submitter:	Zavation LLC400 Liberty Park DriveFlowood, MS 39232Phone: 601-919-1119Fax: 800-447-1302
Contact person:	John Walker
Type of 510(k) submission:	Traditional
Trade name:	Zavation Z-Link Cervical
Common name:	Intervertebral Body Fusion Device
Classification regulation:	21 CFR 888.3080 Intervertebral body fusion device
Device classification:	Class II
Classification Panel:	Orthopedic
Product code:	OVE
Basis for submission:	New device

Device Description:

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Intended Use:

Materials:

The spacer component is manufactured from medical grade PEEK Zeniva ZA-500 (ASTM F2026) with a Tantalum alloy position marker (ASTM F560). The plate and screws are titanium alloy (ASTM F136).

Predicate Devices:

LDR Spine Cervical Interbody Fusion System (K091088) Zavation IBF System (K120576) Synthes Zero-P VA (K121852) SpineSmith IN:C2 Spinal Fixation System (K122630) Globus Coalition Spacer (K131449)

Performance Data:

Mechanical test results demonstrated that the Zavation Z-Link Cervical is substantially equivalent to the predicate devices. Testing was performed in accordance with:

· ASTM F2077, Test Methods for Intervertebral Body Fusion Devices
- o Static Axial Compression
- Dynamic Axial Compression o
- Static Torsion o
- o Dynamic Torsion
. ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
. ASTM Draft F04.25.02.02, Static Pushout Test Method for Intervertebral Body Fusion Devices.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.