The COALITION AGX™ Plate 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.

The COALITION AGX™ Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-TI) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The COALITION AGX™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation such as the COALITION AGX™ Plate, ASSURE®, PROVIDENCE™, VIP®, XTEND®, or UNIFY™ Anterior Cervical Plate Systems. When used with the COALITION AGX™ Plate, the assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGXTM Plate acting as the supplemental fixation.

Device Description

The COALITION AGX™ Plate is an anterior, cervical fixation device available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates are made from titanium alloy, as specified in ASTM F136, F1295, and F1472. The screws for use with the COALITION AGX™ Plates are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

COALITION AGX™ Spacers are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The spacers are available in various heights and footprints to fit the anatomical needs of a wide variety of patients. These devices are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The COALITION AGX™ Spacers are manufactured from radiolucent PEEK polymer. with titanium alloy or tantalum markers, as specified in ASTM. F2026, F136. F1295, F1472, and F560.

AI/ML Overview

This document describes the COALITION AGX™ Plate and COALITION AGX™ Spacer, which are devices intended for anterior screw fixation to the cervical spine and as an interbody fusion device, respectively. The document focuses on regulatory clearance and substantial equivalence to predicate devices, rather than an AI-powered device. Therefore, much of the requested information regarding AI device evaluation is not available.

Here's an analysis based on the provided text, highlighting the information that is present and noting what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Type of Test)	Reported Device Performance (Summary)
COALITION AGX™ Plate:
Static Compression Bend	Conducted; performance deemed acceptable and substantially equivalent to predicates.
Dynamic Compression Bend	Conducted; performance deemed acceptable and substantially equivalent to predicates.
Static Torsion	Conducted; performance deemed acceptable and substantially equivalent to predicates.
COALITION AGX™ Spacer:
Static Compression	Conducted; performance deemed acceptable and substantially equivalent to predicates.
Dynamic Compression	Conducted; performance deemed acceptable and substantially equivalent to predicates.
Static Compression-Shear	Conducted; performance deemed acceptable and substantially equivalent to predicates.
Dynamic Compression-Shear	Conducted; performance deemed acceptable and substantially equivalent to predicates.
Static Torsion	Conducted; performance deemed acceptable and substantially equivalent to predicates.
Dynamic Torsion	Conducted; performance deemed acceptable and substantially equivalent to predicates.
Subsidence	Conducted; performance deemed acceptable and substantially equivalent to predicates.
COALITION AGX™ Plate and Spacer (Assembly):
Static Compression	Conducted; performance deemed acceptable and substantially equivalent to predicates.
Compression-Shear	Conducted; performance deemed acceptable and substantially equivalent to predicates.
Torsion	Conducted; performance deemed acceptable and substantially equivalent to predicates.
Expulsion	Conducted; performance deemed acceptable and substantially equivalent to predicates.
Subsidence	Conducted; performance deemed acceptable and substantially equivalent to predicates.
Plate Pull-Off	Conducted; performance deemed acceptable and substantially equivalent to predicates.
Design Validation/Cadaver Testing	Conducted; ensured performance is acceptable and substantially equivalent to predicates.
Biomechanical Cadaveric Testing	Conducted; demonstrated substantial equivalence to predicate device(s).

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

The document does not specify exact sample sizes for the mechanical tests, but refers to testing "in accordance with the Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s (May 3, 2004) and ASTM F1717, F2077 and F2267, as applicable." These standards would define typical numbers of samples.

The "design validation/cadaver testing" and "biomechanical cadaveric testing" imply the use of cadaveric specimens, which would likely be prospective data. The country of origin of this cadaveric data is not specified.

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

This information is not applicable to the type of device and study described. Mechanical and biomechanical tests typically rely on standardized measurement techniques and established engineering principles, rather than expert interpretation for "ground truth."

4. Adjudication method for the test set

Not applicable. Mechanical and biomechanical tests involve objective measurements rather than expert adjudication.

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 is not an AI device.

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

Not applicable. This is not an AI device. The device's performance is standalone in the sense that it performs its physical function without human-in-the-loop "performance" in the analytical sense.

7. The type of ground truth used

For the mechanical and biomechanical tests, the "ground truth" would be established by:

Standardized Test Methods and Specifications: Adherence to ASTM standards (F1717, F2077, F2267) and FDA guidance for spinal systems, which define acceptable performance ranges and methodologies.
Predicate Device Performance: The primary "ground truth" for substantial equivalence is the performance of the legally marketed predicate devices (SUSTAIN® Radiolucent Medium, VIP® Anterior Cervical Plate System, InterPlateTM C, IN:C2TM Spinal Fixation System, PEEK Prevail® Cervical Interbody Device, PATRIOT® Colonial® ACDF Spacer, COALITION® Spacer). The new device's performance is compared against these benchmarks.
Cadaveric Data: For the design validation and biomechanical cadaveric testing, the "ground truth" would be the actual physical responses observed in the cadaveric specimens under specific loading conditions, measured against established biomechanical principles and potentially compared to existing literature or predicate device behavior.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable. This is not an AI device, so there is no "training set" or corresponding ground truth establishment in this context.

Summary

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April 9, 2015

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

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

Re: K142218

Trade/Device Name: COALITION AGX™ Plate and COALITION AGX™ Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, OVE, KWQ Dated: March 31, 2015 Received: March 31, 2015

Dear Dr. Baker:

This letter corrects our substantially equivalent letter of March 31, 2015.

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, 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

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

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.

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" (21CFR 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K142218

Device Name

COALITION AGX™ Plate and COALITION AGX™ Spacer

Indications for Use (Describe)

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

区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY: COALITION AGX™ System

Company:	Globus Medical Inc.2560 General Armistead AvenueAudubon, PA 19403(610) 930-1800
Contact:	Kelly Baker, Ph.D.Senior Vice President, Regulatory and Clinical Affairs
Date Prepared:	March 23, 2015
Device Name:	COALITION AGXTM Plate and COALITION AGXTM Spacer
Classification:	21CFR §888.3080 Intervertebral Body Fusion Devices21CFR §888.3080 Intervertebral Fusion Device withIntegrated Fixation, CervicalProduct Codes: ODP, OVERegulatory Class: II; Panel Code: 8721CFR §888.3060 Spinal Intervertebral Body FixationOrthosisProduct Code: KWQRegulatory Class: II; Panel Code: 87
Primary Predicate:	SUSTAIN® Radiolucent Medium (K130478)
AdditionalPredicates:	VIP® Anterior Cervical Plate System (K081391)InterPlateTM C (K092070)IN:C2TM Spinal Fixation System (K122630)PEEK Prevail® Cervical Interbody Device (K073285)PATRIOT® Colonial® ACDF Spacer (K072991)COALITION® Spacer (K083389)

Purpose:

The purpose of this submission is to request clearance for the COALITION AGX™ Plate and COALITION AGX™ Spacer.

Device Description:

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Indications for Use:

The COALITION AGX™ Plate 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.

The COALITION AGX™ Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The COALITION AGX™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the COALITION AGX™ Plate, ASSURE®, PROVIDENCE™, VIP®, XTEND®, or UNIFY™ Anterior Cervical Plate Systems. When used with the COALITION AGX™ Plate, the assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGX™ Plate acting as the supplemental fixation.

Performance Data:

Mechanical testing for the COALITION AGX™ Plate (static and dynamic compression bend, and static torsion), for the COALITION AGX™ Spacer (static and dynamic compression, static and dynamic compression-shear, static and dynamic torsion, and subsidence), and for the COALITION AGX™ Plate and Spacer (static compression, compression-shear, torsion, expulsion, subsidence, and plate pull-off) was conducted in accordance with the Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s (May 3, 2004) and ASTM F1717, F2077 and F2267, as applicable. Design validation/cadaver testing was conducted to ensure the COALITION AGX™ System performance is acceptable for its intended use and to ensure substantial equivalence to the predicate(s). Biomechanical cadaveric testing was also conducted. Performance and comparative analysis data demonstrate substantial equivalence to the predicate device(s).

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K142218 Page 3 of 3

Basis for Substantial Equivalence:

COALITION AGX™ implants are similar to the predicate devices with respect to technical characteristics, performance, design, materials, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. COALITION AGX™ implants are as safe, as effective, and perform as well as or better than predicate devices.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.