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

ASSURE®-T Translational Anterior Cervical Plates are anterior cervical plates that allow translation for intraoperative graft compression and postoperative settling. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7) using standard ASSURE® screws. The implants are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

AI/ML Overview

The provided text describes a medical device's 510(k) submission, specifically the ASSURE® Anterior Cervical Plate System, and its modification, the ASSURE®-T Translational Anterior Cervical Plates. The document focuses on regulatory approval and substantial equivalence to predicate devices, rather than a clinical study demonstrating the device meets acceptance criteria.

Therefore, much of the requested information cannot be extracted directly from this document, as it pertains to a clinical trial design and execution, which is not present here. The document details the device's indications for use, its classification, and notes that mechanical testing was performed.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative clinical acceptance criteria (e.g., success rates, complication rates) or reported device performance in a clinical setting. It mentions mechanical testing:

Acceptance Criteria (Implied)	Reported Device Performance (from mechanical testing)
Mechanical integrity and strength suitable for anterior cervical plate systems, as per ASTM F1717 and FDA Guidance.	Performance demonstrated "substantial equivalence to the predicate device" in static and dynamic compression bending, and static torsion.

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

The document does not describe a clinical test set or its sample size. The testing mentioned is mechanical.

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

Not applicable as no clinical test set or ground truth determination by experts is described.

4. Adjudication method for the test set

Not applicable as no clinical test set or adjudication method is described.

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 device is a physical medical implant (anterior cervical plate), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.

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

Not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the mechanical testing performed, the "ground truth" would be the engineering specifications and performance benchmarks established by ASTM F1717 and the FDA guidance for spinal systems. There is no clinical ground truth discussed in this document.

8. The sample size for the training set

Not applicable. The concept of "training set" is relevant for machine learning algorithms, which this device is not. For a physical device, development and design are based on engineering principles and regulatory requirements, not a data training set.

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

Not applicable for the same reasons as above. The "ground truth" for the device's design and manufacturing would be established through engineering design specifications, material properties, and manufacturing quality control, all conforming to established standards and regulations.

Summary

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K183056

Device Name ASSURE® Anterior Cervical Plate System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the words "U.S. Food & Drug Administration".

April 19, 2019

Globus Medical, Inc. Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K183056

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 26, 2019 Received: March 27, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Summary: ASSURE-T Anterior Cervical Plate

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
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Contact: Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
Date Prepared: October 31, 2018
Device Name: ASSURE® Anterior Cervical Plate System
Anterior Cervical Plate System Common Name:
Per 21 CFR as follows: Classification: §888.3060 Spinal Intervertebral Body Fixation Orthosis Product Code: KWQ Regulatory Class: II, Panel Code: 87

Primary Predicate: ASSURE® (K040721)

Additional

Predicates: UNIFY® (K121049, K133567) Aesculap ABC2 (K050813)

Purpose:

The purpose of this 510(k) is to request clearance for the ASSURE®-T Translational Anterior Cervical Plates, a modification of the predicate ASSURE® Anterior Cervical Plate System.

Device Description:

Indications for Use:

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 scollosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

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Technological Characteristics:

ASSURE®-T implants have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.

Performance Data:

Mechanical testing (static and dynamic compression bending, and static torsion) was conducted in accordance with ASTM F1717 and, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device.

Basis of Substantial Equivalence:

The ASSURE®-T Translational Anterior Cervical Plate has been found to be substantially equivalent to the predicates with respect to technological characteristics, performance, design, materials, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate 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.