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

AI/ML Overview

The provided text describes a 510(k) summary for the PROVIDENCE™ Anterior Cervical Plate System. It focuses on the device's description, intended use, and substantial equivalence to a predicate device, supported by mechanical testing. However, it does not include the information requested in your prompt regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert involvement, adjudication, MRMC studies, standalone performance), or ground truth establishment.

A 510(k) submission primarily demonstrates that a new device is substantially equivalent to a legally marketed predicate device. This often relies on comparing technical characteristics and performance data (like mechanical testing, as mentioned here) to show that the new device is as safe and effective as the predicate. It typically does not involve the types of human-reader or diagnostic performance studies that are relevant to your inquiry, especially for devices like spinal plate systems.

Therefore, I cannot fulfill your request using the provided input as the necessary information is not present.

Summary

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510(k) Summary =

APR 1 9 2007

DEVICE NAME: PROVIDENCE™ Anterior Cervical Plate System

SUBMITTED BY:

Globus Medical Inc. Valley Forge Business Center 2560 General Armistead Ave. Audubon, PA 19403 (610) 415-9000 Contact: Kelly J. Baker, PhD

CLASSIFICATION:

21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis Product code KWQ. Regulatory Class II. Panel code 87.

PREDICATE DEVICE:

ASSURE® Anterior Cervical Plate System K040721 (SE June 17, 2004) Product code KWQ. Regulatory Class II.

DEVICE DESCRIPTION:

INTENDED USE:

PERFORMANCE DATA:

Mechanical testing in accordance with the "Guidance for Industry and FDA Staff. Guidance for Spinal Systems 510(k)s", May 3, 2004 is presented.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The PROVIDENCE™ Anterior Cervical Plate System implants are similar to the predicate ASSURE® devices with respect to technical characteristics, performance, and intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globus Medical, Inc. % Kelly J. Baker, Ph.D. Director, Regulatory and Clinical Affairs Valley Forge Business Center 2560 General Armistead Ave. Audubon, Pennsylvania 19403

APR 1 9 2007

K070775 Re:

Trade/Device Name: Providence Anterior 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 16, 2007 Received: March 21, 2007

Dear Dr. 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

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Page 2 - Kelly J. Baker, Ph.D.

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. 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 Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sincerely yours,

Mark A Millhenn

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 ll.

K070775 510(k) Number:

PROVIDENCE™ Anterior Cervical Plate System Device Name:

Indications:

Prescription Use X (Per 21 CFR §801.109) Over-The-Counter Use _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milkerson

18ton Sign-O Division of General, Restorative, and Neurological Devices

510(k) Number K070775

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.