The ASSURE™ 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 ASSURE™ Anterior Cervical Plate System consists of plates used with either standard screws or rigid screws and set 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.

AI/ML Overview

The acceptance criteria and study proving device performance are detailed below:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
In accordance with ASTM F1717 for static and dynamic mechanical testing	Meets static and dynamic mechanical testing requirements of ASTM F1717

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a distinct "test set" in the traditional sense of a clinical or image-based study. The testing performed was mechanical testing, specifically static and dynamic tests, to assess the physical properties of the device. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) is not applicable in this context. The sample size for the mechanical testing is not explicitly stated, but typically involves multiple samples for each test condition as per ASTM F1717.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable. The "ground truth" for mechanical testing is established by the test method (ASTM F1717) and the physical properties observed. There were no human experts establishing ground truth in the context of these mechanical performance tests.

4. Adjudication Method for the Test Set

This question is not applicable. Mechanical testing results are objective measurements and do not require expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study conducted was mechanical testing, not a clinical study involving human readers or cases.

6. Standalone Performance Study

Yes, a standalone study was done, but it was a standalone mechanical performance study, not an algorithm-only without human-in-the-loop performance study (which would be relevant for AI/software devices). The device, the ASSURE™ Anterior Cervical Plate System, underwent static and dynamic mechanical testing in accordance with ASTM F1717. This evaluates the intrinsic physical performance of the device itself.

7. Type of Ground Truth Used

The ground truth used was conformance to a recognized standard, specifically ASTM F1717. This standard defines the methodologies and expected performance criteria for static and dynamic mechanical testing of spinal intervertebral body fixation orthoses.

8. Sample Size for the Training Set

This question is not applicable. There was no "training set" as this was mechanical testing of a physical device, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there was no "training set." The performance was evaluated against a standardized mechanical testing protocol (ASTM F1717).

Summary

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510(K) Summary III.

0407d/
page 1 of 2

SUBMITTED BY:

Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 (610) 415-9000 x218 Contact: Kelly J. Baker Prepared: March 18, 2004

DEVICE NAME:

ASSURE™ Anterior Cervical Plate System

CLASSIFICATION:

The device classification is Class II as per 21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis. The product code is KWQ. The panel code is 87.

PREDICATE DEVICES:

Synthes CSLP: K926453, SE date October 12, 1993; K030866, April 18, 2003. Depuy PEAK: K971730, SE date November 3, 1997. Howmedica Osteonics (Stryker) Reflex: K031702, SE date August 8, 2003. The product code for these devices is KWQ.

DEVICE DESCRIPTION:

INTENDED USE:

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yoZal

510(k) Premarket Notification - ASSURE™System

PERFORMANCE DATA:

Static and dynamic mechanical testing, in accordance with ASTM F1717, was State and dynamic moonamed. As a basis for substantial equivalence.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The ASSURE™ Anterior Cervical Plate System implants are similar to the predicate Synthes CSLP (K926453, K030866), Depuy PEAK (K971730), Howmedica Osteonics (Stryker) Reflex (K031702), anterior cervical plate systems with respect to technical characteristics and performance.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of three stylized human figures in profile, representing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2004

Globus Medical Inc. . c/o Kelly J. Baker, Ph.D. 303 Schell Lanc Phoenixville, PA 19460

Re: K040721

Trade/Device Name: ASSURE™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 18, 2004 Received: March 19, 2004

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 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Sections 557 - 32 described in your Section 510(k)
This letter will allow you to begin marketing your device of your davice to a legal This letter will anow you to begin makemig your antial equivalence of your device to a legally premarket notification. The FDA iniding of substanted by July 2017 11:50
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
r the regulation and consisted on the collected on the regulation ontitled If you desire specific advice for your de not of the mote the regulation entitled. contact the Office of Complanes at (301) 27 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - Division of Small " Misbranding by reference to premarket nouthead on the Act from the Division of Small other general information on your responsible and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-frememain html Manufacturers, International and Consumer Passion. As a gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

R. Mark A. Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification - ASSURE™System

II.	Indications for Use Statement
-----	-------------------------------

510(k) Number:	K040721
Device Name:	ASSURE™ Anterior Cervical Plate System

Indications:

The ASSURE™ Anterior Cervical Plate System is intended for anterior screw The ASSURL - Antenor Oct Noar Flato System Andications: degenerative likation to the cervical Spine SE Onlin of discogenic origin with degeneration of disc disease (as delined by nook pain of accographic studies), trauma the uise connimed by pations history ity (defined as kyphosis, lordosis, or (Including fractures), turnors, dolormity (dolined aspondylolisthesis, and spinal stenosis.

Prescription Use (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)

Mark N. Wilkerson

Division of General, Restorative, and Neurological Devices

510(k) Number K04072

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.