The COALITION® Spacer is a stand-alone 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 nonoperative treatment. The COALITION® Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.

Device Description

The COALITION® Spacer is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.

The COALITION® Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

AI/ML Overview

The provided text describes a 510(k) summary for the COALITION® Spacer, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing. It does not contain information about clinical studies with human participants, AI algorithms, or the evaluation of diagnostic performance against expert ground truth.

Therefore, many of the requested categories for AI/clinical performance studies cannot be addressed from the given text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (What was tested)	Reported Device Performance (How determined to be "met")
Static compression	Tested in accordance with ASTM F2077 and "Class II Special Controls Guidance Document: Intervertebral Fusion Device" to demonstrate substantial equivalence to predicate systems.
Dynamic compression	Tested in accordance with ASTM F2077 and "Class II Special Controls Guidance Document: Intervertebral Fusion Device" to demonstrate substantial equivalence to predicate systems.
Static compression-shear	Tested in accordance with ASTM F2077 and "Class II Special Controls Guidance Document: Intervertebral Fusion Device" to demonstrate substantial equivalence to predicate systems.
Dynamic compression-shear	Tested in accordance with ASTM F2077 and "Class II Special Controls Guidance Document: Intervertebral Fusion Device" to demonstrate substantial equivalence to predicate systems.
Expulsion	Tested in accordance with ASTM F2077 and "Class II Special Controls Guidance Document: Intervertebral Fusion Device" to demonstrate substantial equivalence to predicate systems.

Note: The document states that these tests were conducted and that they demonstrated substantial equivalence, but it does not provide the specific numerical acceptance criteria or the quantitative results from these tests.

Regarding the study that proves the device meets acceptance criteria:

The study described is a mechanical performance study.

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

Test Set Sample Size: Not explicitly stated. For mechanical testing of medical devices, sample sizes are typically determined by relevant ASTM standards, but the specific number of units tested for each criterion is not provided in this summary.
Data Provenance: Not applicable in the context of human data. These are laboratory mechanical tests, not clinical data sets from patients or countries.

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

Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods, not expert human interpretation.

4. Adjudication method for the test set:

Not applicable. This refers to consensus among human experts for clinical data, not mechanical testing results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This study is focused on the mechanical performance of a physical implant, not the diagnostic performance or AI assistance in interpretation.

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

Not applicable. This refers to AI algorithms, which are not mentioned in this device description. The device itself is a physical implant.

7. The type of ground truth used:

For mechanical testing, the "ground truth" is defined by the specifications and acceptable ranges outlined in the relevant ASTM standards (F2077) and the FDA's "Class II Special Controls Guidance Document: Intervertebral Fusion Device."

8. The sample size for the training set:

Not applicable for a physical medical device and mechanical testing. There is no "training set" in the context of algorithm development mentioned here.

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

Not applicable. There is no training set for an AI algorithm mentioned.

Summary

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K131449

510(k) SUMMARY: COALITION® Spacer

JUL 3 0 2013

Company:	Globus Medical Inc.
	2560 General Armistead Ave.
	Audubon, PA 19403
	(610) 930-1800

Christina Kichula Contact: Group Manager, Regulatory Affairs

Date Prepared: May 17, 2013

Device Name: COALITION® Spacer

Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Devices. Product Code OVE. Requlatory Class II. Panel Code: 87.

COALITION® Spacer (K083389) Predicate(s): Synthes® Zero-P (K112459)

Purpose:

The purpose of this submission is to request clearance for additional sizes of COALITION® Spacers.

Device Description:

Intended Use:

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patients should be skeletally mature and have had at least six (6) weeks of nonoperative treatment. The COALITION® Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.

Technological Characteristics:

The technological characteristics of the additional COALITION® Spacer are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics.

Performance Data:

Mechanical testing consisting of static and dynamic compression, static and dynamic compression-shear, and expulsion was conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, and ASTM F2077 to demonstrate substantial equivalence to the predicate systems.

Basis for Substantial Equivalence:

The COALITION® Spacer additional implants are similar to the predicate systems with respect to technical characteristics, performance and intended use. The information provided within this premarket notification supports substantial equivalence of the subject spacers to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

July 30, 2013

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

Globus Medical Incorporated % Ms. Christina Kichula Group Manager. Regulatory Affairs 2560 General Armistead Avenue Audubon. Pennsvivania 19403

Re: K131449

Trade/Device Name: COALITION" Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: May 17, 2013 Received: May 20, 2013

Dear Ms. Kichula:

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 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

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Page 2 -- Ms. Christina Kichula

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 requiation 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 Small Manufacturers, International and Consumer Assistance 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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Page 1 of 1

Indications for Use Statement

510(k) Number:

K131449

Device Name:

COALITION® Spacer Commen

Indications:

X_____________________________________________________________________________________________________________________________________________________________________________ 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)

Anton E. Dmitriev, PhD Division of Orthopedic 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.