The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

Device Description

The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.

AI/ML Overview

This document describes the Zavation Cervical Plate System, a medical device. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance. It does not contain information typically found in a study for an AI/ML diagnostic device, such as acceptance criteria based on metrics like sensitivity/specificity, nor does it discuss ground truth establishment, expert adjudication, or reader studies.

Therefore, many of the requested categories related to AI/ML device studies are not applicable to this submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from submission)	Reported Device Performance (from submission)
Perform as well as or better than predicate devices under ASTM F1717 for:	The mechanical test results demonstrated that the Zavation Cervical Plate System performs as well as or better than the predicate devices.
- Static compression bending	Demonstrated as well as or better than predicate devices.
- Static torsion	Demonstrated as well as or better than predicate devices.
- Dynamic compression bending	Demonstrated as well as or better than predicate devices.

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

Sample size: Not specified. The submission refers to "a worst-case, cervical plate construct" being tested, implying a limited number of constructs rather than a large clinical test set.
Data provenance: Mechanical testing was performed according to ASTM F1717. This is laboratory-based testing, not human data.

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

Not applicable. Ground truth for mechanical performance is established by standardized testing protocols (ASTM F1717) and engineering measurements, not by expert medical review.

4. Adjudication method for the test set

Not applicable. See point 3.

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

Not applicable. This is a spinal implant device, not an AI/ML diagnostic device requiring a reader study.

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

Not applicable. This is a spinal implant device, not an AI/ML diagnostic device.

7. The type of ground truth used

"Ground truth" was established through standardized mechanical testing (ASTM F1717) on physical device constructs, measuring parameters like bending strength, torsion stability, and fatigue resistance.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML system that requires a training set. Development and validation rely on engineering design principles and physical testing.

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

Not applicable. See point 8.

Summary

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Attachment 4 - 510(k) Summary

APR 2 5 2013

510K Summary

Date:	March 13, 2013
Submitter:	Zavation LLC501 Avalon WayBrandon, MS 39047Phone: 601-919-1119Fax: 800-447-1302
Contact person:	John Walker
Type of 510(k) submission:	Traditional
Trade name:	Zavation Cervical Plate System
Common name:	Anterior Cervical Plate
Classification regulation:	888.3060
Device classification:	Class II
Classification Panel:	Orthopedic
Product code:	KWQ
Basis for submission:	Addition of optional screws and plates

Device Description:

Intended Use:

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Materials:

The Zavation Cervical Plate System components are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136.

Predicate Device:

ALINE, Smith & Nephew (K943523) CSLP, Synthes (K945700) Vectra-one, Synthes (K071667) Uniplate, Depuy Spine (K042544) Zavation Cervical Plate (K112533)

Technological Characteristics:

The Zavation Cervical Plate System possesses the same technological characteristics as the predicate. These include: basic design (plate designed fixation system having various screw diameters and lengths), material (titanium alloy), sizes (variety of plate and screw sizes), and intended use (as described above).

Performance Data:

Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. The mechanical test results demonstrated that the Zavation Cervical Plate System performs as well as or better than the predicate devices.

Conclusion:

The Zavation Cervical Plate System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.

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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 stylized eagle with three bars representing the department's services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

Letter dated: April 25, 2013

Zavation. LLC % Mr. John Walker Engineering Manager 501-Avalon_Way_ Brandon, Mississippi 39047

Re: K130030

Trade/Device Name: Zavation Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: March 13, 2013 Received: March 18, 2013

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. John 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 Small Manufacturers, International and Consumer Assistance at its tollfree-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" (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 Small Manufacturers, International and Consumer Assistance 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,

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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Attachment 3 - Indications for Use Statement

Indications for Use

510(k) Number (if known): K130030

Device Name: Zavation Cervical Plate System

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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.