The VIP™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

Device Description

The VIP™ Anterior Cervical Plate System consists of plates of various lengths to be used with either variable angle screws or fixed angle screws. Each VIP plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). VIP™ implants are composed of titanium alloy, as specified in ASTM F136, F1295.

AI/ML Overview

This document is a 510(k) Summary for the VIP™ Anterior Cervical Plate System, a medical device for spinal fixation. It describes the device, its intended use, and its substantial equivalence to predicate devices based on mechanical testing. However, it does not contain the information required to answer your questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what's missing:

Acceptance Criteria and Reported Performance: The document states that "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." This indicates that mechanical tests were performed, but the document does not report the specific acceptance criteria (e.g., minimum load to failure, maximum displacement under load) nor the actual results of these tests for the VIP system or its predicates.
Study Details (Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone): The document refers to "mechanical testing" – this is a physical bench test of the device, not a study involving human subjects, data analysis, or ground truth establishment in the way you're asking about (e.g., for an AI device). Therefore, none of the questions related to these aspects (sample size for test set, data provenance, number of experts, adjudication, MRMC, standalone performance, type of ground truth, training set details) are applicable or answerable from the provided text.

In summary, the provided text confirms that mechanical testing was performed to demonstrate substantial equivalence, but it does not detail the specific acceptance criteria, test results, or any clinical study information that would be relevant to the questions you've posed.

Summary

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K081391/

510(K) Summary: VIP™ Anterior Cervical Plate System

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403(610) 415-9000	JUL - 3 2008
Contact:	Kelly J. Baker, Ph.DDirector, Clinical Affairs & Regulatory
Device Name:	VIP™ Anterior Cervical Plate System
Classification:	Per 21 CFR as follows:§888.3060 Spinal Intervertebral Body Fixation OrthosisProduct Code KWQ.Regulatory Class II and III, Panel Code 87.
Predicate(s):	Globus Medical ASSURE® Anterior Cervical Plate SystemK040721, SE date June 14, 2004, and PROVIDENCE™Anterior Cervical Plate System K070775, SE date April 19, 2007

Device Description:

Intended Use:

Basis of Substantial Equivalence:

VIP™ Anterior Cervical Plate System is similar to the predicate systems with respect to technical characteristics, performance, and intended use. Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is smaller than the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2008

Globus Medical, Inc. % Ms. Kelly J. Baker 2560 General Armistead Avenue Valley Forge Business Center Audubon, PA 19403

Re: K081391

Trade/Device Name: VIP Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: June 19, 2008 Received: June 23, 2008

Dear Ms. Baker:

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 - Ms. Kelly J. Baker

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:

Device Name: VIP™ Anterior Cervical Plate System

INDICATIONS:

Prescription Use × OR (Per 21 CFR §801.109)

Over-The-Counter Use_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

6081391 510/k) Number

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.