The Zavation Z-Link Lumbar is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Z-Link Lumbar is to be filled with autogenous bone graft material.

Device Description

The Zavation Z-Link Lumbar 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 four holes for inserting two bone screws 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 text describes a medical device, the "Zavation Z-Link Lumbar," and its 510(k) premarket notification. This document is a regulatory submission for a medical device and does not contain information about an AI/ML-based device. Therefore, the questions regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device cannot be answered from this text.

The document discusses the substantial equivalence of a physical intervertebral body fusion device to predicate devices based on mechanical performance data.

Here's an analysis of what is available in the document, which pertains to the physical device rather than an AI/ML system:

1. A table of acceptance criteria and the reported device performance

The document states: "Mechanical test results demonstrated that the Zavation Z-Link Lumbar is substantially equivalent to the predicate devices." It also lists the ASTM standards used for testing:

ASTM F2077, Test Methods for Intervertebral Body Fusion Devices
- Static Axial Compression
- Dynamic Axial Compression
- Static Shear
- Dynamic Shear
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.

However, the specific numerical acceptance criteria (e.g., minimum load, maximum displacement) and the exact reported performance values from these tests are not provided in this summary. The submission concludes that the device meets the criteria by stating "substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document pertains to mechanical testing of a physical device. "Test set" in the context of an AI/ML model's performance study does not apply here. For mechanical tests, the "sample size" would refer to the number of physical devices tested. This information is not provided in the document. Data provenance (country of origin, retrospective/prospective) is irrelevant for mechanical testing of a manufactured product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The "ground truth" for a physical device's mechanical performance is established through standardized engineering tests, not by expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are relevant for subjective interpretations (e.g., medical image reading) in clinical studies, not for objective mechanical performance tests.

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

This question is not applicable as the device is a physical intervertebral fusion device, not an AI/ML software.

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

This question is not applicable as the device is a physical intervertebral fusion device, not an AI/ML software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this physical device is its mechanical performance as measured against established engineering standards (ASTM F2077, ASTM F2267, ASTM Draft F04.25.02.02).

8. The sample size for the training set

This question is not applicable as the device is a physical intervertebral fusion device, not an AI/ML software model that requires a training set.

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

This question is not applicable as the device is a physical intervertebral fusion device, not an AI/ML software model.

Summary

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

December 19, 2014

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

Re: K142271

Trade/Device Name: Zavation Z-Link Lumbar Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: November 25, 2014 Received: November 26, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Lawrence Walker

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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.

Mark N. Melkerson -S

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) K142271

Device Name Zavation Z-Link Lumbar

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)

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510K Summary

Date:	December 19, 2014
Submitter:	Zavation LLC400 Liberty Park DriveFlowood, MS 39232Phone: 601-919-1119Fax: 800-447-1302
Contact person:	Lawrence Walker
Type of 510(k) submission:	Traditional
Trade name:	Zavation Z-Link Lumbar
Common name:	Intervertebral Fusion Device with Integrated Fixation, Lumbar
Classification regulation:	21 CFR 888.3080 Intervertebral body fusion device
Device classification:	Class II
Classification Panel:	Orthopedic
Product code:	OVD
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:

Synthes SynFix-LR (K072253) - Primary Zavation IBF System (K120576)

Performance Data:

Mechanical test results demonstrated that the Zavation Z-Link Lumbar 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
- o Dynamic Axial Compression
- Static Shear o
- Dynamic Shear O
. 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.

Summary of Technological Characteristics:

The Zavation Z-link Lumbar device is substantially equivalent to the cited predicate(s) in design, material, and intended use.

Conclusions:

The device description and testing completed demonstrate that the device is substantially equivalent to the cited predicates for the stated intended use.

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.