When intended to promote fusion of the occipitocervical spine, cervical spine and the thoracic spine, (Occiput -T3), the Virage OCT Spinal Fixation System is indicated for the following:

Degenerative disc disease (DDD) (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Plate/Rod/Occipital Screws/Hooks

Occipitocervical plate, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat occipitocervical and cervical conditions, the occipital screws are limited to occipital fixation only. The occipital screws are not intended for the cervical spine.

Hooks and Rods

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Thoracic Screws

The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. The thoracic screws are not intended to be placed in the cervical spine.

Rod Connectors

The Virage OCT Spinal Fixation System can also be linked to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine using rod connectors and transition rods.

The titanium SONGER® Spinal Cable System to be used with the Virage OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

Device Description

The Zimmer Spine Virage OCT Spinal Fixation System is a posterior system intended for the Occipital-Cervical-Thoracic spine (Occiput-T3). The system consists of a variety of rods, anchors, transverse connectors, screws, and polyaxial screws to achieve an implant construct as necessary for the individual case. The system also includes the instruments necessary for inserting and securing the implants. The implant system is intended to be removed after solid fusion has occurred.

The Virage System implants are fabricated from medical grade titanium alloy and medical grade cobalt chromium alloy. Implants made from medical grade titanium. medical grade titanium alloy, and medical grade cobalt chromium may be used together, Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same construct. All implants are single use only and should not be reused under any circumstances. Refer to the product label to determine if instrumentation is intended for single use.

AI/ML Overview

The Zimmer Spine Virage OCT Spinal Fixation System is a medical device, not an AI/ML product, so the provided document does not contain information on acceptance criteria for AI algorithms, or studies related to AI/ML performance.

However, based on the provided text, I can extract information related to the device's mechanical performance acceptance criteria and the study that proves the device meets those criteria:

Device Acceptance Criteria and Performance

Acceptance Criteria Category	Standard / Test	Reported Device Performance
Occipito-Cervical Portion Mechanical Testing	ASTM F2706	"All performance testing passed the acceptance criteria and demonstrated the device performed as well or better than the predicate systems."
Thoracic Portion Mechanical Testing	ASTM F1717	"All performance testing passed the acceptance criteria and demonstrated the device performed as well or better than the predicate systems."
Select Components Testing	ASTM F1798	"All performance testing passed the acceptance criteria and demonstrated the device performed as well or better than the predicate systems."

Study Details for Mechanical Performance

Since the device is a medical implant and not an AI/ML system, the following questions are not applicable in their original context related to AI/ML studies. However, I will address them in the context of the mechanical testing study where possible.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states "Worst case constructs of the occipito-cervical portion of the Virage System were tested per ASTM F2706. Worst case constructs of the thoracic portion of the Virage System were tested per ASTM F1717. Select components were also tested per ASTM F1798."
- The exact sample size (number of constructs or components tested) is not specified in the provided text.
- Data provenance is not explicitly mentioned, but the tests were conducted according to ASTM (American Society for Testing and Materials) standards, which are internationally recognized. This is a prospective test in the sense that the testing was performed specifically to demonstrate mechanical performance for this 510(k) submission.
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 (N/A) to mechanical testing. The "ground truth" for mechanical testing is defined by the objective pass/fail criteria outlined in the ASTM standards (F2706, F1717, F1798), not by expert human interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is N/A for mechanical testing. Adjudication methods are typically used for subjective assessments or when multiple human reviewers are involved. Mechanical tests have objective pass/fail criteria.
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 is N/A as this is a mechanical medical device, not an AI/ML product. No human readers or AI assistance are involved in evaluating its mechanical effectiveness.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is N/A as this is a mechanical medical device. There is no algorithm to test in a standalone manner.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the mechanical testing, the "ground truth" is the objective pass/fail criteria defined by the relevant ASTM standards (F2706, F1717, F1798). These standards establish the expected mechanical performance (e.g., fatigue strength, static strength) that the device must meet.
The sample size for the training set
- This is N/A as this is a mechanical medical device. There is no AI model requiring a training set.
How the ground truth for the training set was established
- This is N/A as this is a mechanical medical device. There is no AI model requiring a training set or ground truth establishment for training.

Summary

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JUN 0-2-2014

Image /page/0/Picture/2 description: The image shows the logo for Zimmer Spine. The logo consists of a circle with a stylized "Z" inside it, above the words "zimmer" and "spine", with "spine" written in a smaller font. The text is in a sans-serif font and appears to be slightly distressed.

510(k) SUMMARY

Virage OCT Spinal Fixation System

Date of Summary Preparation:

Company:

May 8, 2014

Zimmer Spine, Inc. 7375 Bush Lake Road Minneapolis, MN 55439 USA

2184052 (Minneapolis)

Office: 952.830.6240 Fax: 952.837.6840

Regulatory Affairs Project Manager Email: Holly.Seppanen@zimmer.com

Virage OCT Spinal Fixation System

Holly Seppanen

Establishment Registration Number:

Company Contact:

Trade Name(s):

Device Name (Common Name):

Device Classification:

Regulation Number and Product Code(s):

21 CFR § 888.3050 / KWP

Spinal Fixation System

Requlation Name:

Appliance, Fixation, Spinal Interlaminal

General Device Description:

Class II

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Indications for Use:

When intended to promote fusion of the occipitocervical spine, cervical spine and the thoracic spine, (Occiput -T3), the Virage OCT Spinal Fixation System is indicated for the following:

Occipitocervical Plate/Rod/Occipital Screws/Hooks

Hooks and Rods

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Thoracic Screws

The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. The thoracic screws are not intended to be placed in the cervical spine.

Rod Connectors

The Virage OCT Spinal Fixation System can also be linked to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine using rod connectors and transition rods.

The titanium SONGER® Spinal Cable System to be used with the Virage OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

Summary of Technological Characteristics:

The Virage System is a posterior system intended for the Occipital-Cervical-Thoracic spine (Occiput-T3). The system consists of a variety of rods, anchors, transverse connectors, screws, and polyaxial screws to achieve a spinal implant construct as necessary for the individual case. The Virage System also includes the instruments necessary for inserting and securing the implants.

All implants are single use only and are not to be reused under any circumstances. All instruments are reusable. All implants and instruments are provided clean and nonsterile and must be sterilized by the end user prior to use.

The medical grade titanium alloy utilized in the Virage System implants is Ti-6AI-4V ELI per ASTM F136. The medical grade cobalt chromium alloy utilized in the Virage System implants is Co-28Cr-6Mo per ASTM F1537.

Performance mechanical testing concluded the Virage System performed as intended and fundamental scientific technology remains unchanged from the predicate devices. The Virage System is substantially equivalent to the predicate devices. The technological characteristics including the basic design and materials, i.e. medical grade metallic constructs, are the same.

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In summary, the subject Virage System utilizes medical grade metallic constructs and does not change the fundamental scientific technology of the device as compared to the predicates, it will continue to operate in the same way.

Summary of Performance Testing:

Worst case constructs of the occipito-cervical portion of the Virage System were tested per ASTM F2706. Worst case constructs of the thoracic portion of the Virage System were tested per ASTM F1717. Select components were also tested per ASTM F1798. All performance testing passed the acceptance criteria and demonstrated the device performed as well or better than the predicate systems.

ldentification of Legally Marketed Devices:

Predicate Device Name	FDA 510k Number
Endius Minit Posterior Cervical and Upper Thoracic FixationSystem	K070282
NuVasive® OCT System	K071435
Synthes Synapse, Cervifix, Cervifix Starlock	K091689, K991089, K994187
Vertex Reconstructive System	K003780, K123656

Substantial Equivalence:

Zimmer Spine considers the subject Virage OCT Spinal Fixation System product performance to be substantially equivalent to the predicate devices because there is no significant difference in intended use, mechanical and functional performance and fundamental scientific technology. No new issues of safety and effectiveness are raised due to the similarities between the subject and the legally marketed predicate devices, as each are used to treat similar clinical conditions and represent a similar basic design concept.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 2, 2014

Zimmer Spine, Incorporated Ms. Holly Seppanen Regulatory Affairs Project Manager 7375 Bush Lake Road Minneapolis, Minnesota 55439

Re: K133556

Trade/Device Name: Virage OCT Spinal Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: May 8, 2014 Received: May 9, 2014

Dear Ms. Seppanen:

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, Tille 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 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 - Ms. Holly Seppanen

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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

RonaldiP. Jean -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133556

Device Name

Virage OCT Spinal Fixation System

Indications for Use (Describe)

When intended to promote fusion of the occipitocervical spine and the thoracic spine, (Occiput -T3), the Virage OCT Spinal Fixation System is indicated for the following:

Occipitocervical Plate/Rod/Occipital Screws/Hooks

Occipitocervical plate, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion of Geoureddislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat occipitocervical and cervical conditions, the occipital screws are limited to occipital fixation only. The occipital screws are not intended for the cervical spine.

Hooks and Rods

Hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine.

Thoracic Screws

The use of thoracic screws is limited to placement in TI-T3 for anchoring the construct only. The thoracic screws are not intended to be placed in the cervical spine.

Rod Connectors

The Virage OCT Spinal Fixation System can also be linked to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine using rod connectors and transition rods.

The titanium SONGER® Spinal Cable System to be used with the Virage OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

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

[区] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 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)
Zane W. Wyatt
Division of Orthopedic Devices
FORM FDA 3881 (6/13)	Page 1 of 2
	PSC Publishing Services (301) 411-6740 FF

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.