The MONUMENT™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back 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) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MONUMENT™ Spacer is to be filled with autogenous bone graft material, and is to be used with four titanium alloy screws that accompany the implant. The device is intended to be used with supplemental fixation (i.e. pedicle screws, facet fixation).

Device Description

The MONUMENT™ Spacer is an anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. The MONUMENT™ Spacer is intended to aid in reduction of a Grade 1 spondylolisthesis. The spacer is 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 bonv fixation. The spacer is to be filled with autogenous bone graft material. The MONUMENT™ Spacer is made from radiolucent PEEK polymer and titanium alloy, as specified in ASTM F136, F1295, and F2026. The mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.

AI/ML Overview

This looks like a 510(k) summary for a medical device called the MONUMENT™ Spacer, an intervertebral body fusion device. The summary describes the device, its indications for use, and a brief mention of performance data and substantial equivalence to predicate devices.

However, the provided text does not contain the specific information needed to fulfill your request for acceptance criteria and a study proving those criteria are met.

Here's why and what's missing:

Acceptance Criteria Table: The summary states that mechanical testing was conducted "in accordance with the 'Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device,' June 12, 2007, ASTM F2077, and ASTM 2267." While these documents outline standards for testing, they do not explicitly state the specific numerical acceptance criteria used by Globus Medical for the MONUMENT™ Spacer. For example, it doesn't say "compressive strength must be greater than X N" or "subsidence must be less than Y mm."
Reported Device Performance: The summary broadly states, "Performance and comparative analysis data demonstrate that the different technological features do not affect the safety and effectiveness of the device and support substantial equivalence to the predicate devices." This is a conclusion, not a presentation of the specific performance results (e.g., actual measured ultimate compressive strength, fatigue life cycles, etc.) against specific criteria.
Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document refers to "Mechanical testing" but provides no details about study design, sample sizes, data acquisition methods, or any human reader involvement. This type of device (intervertebral body fusion device) typically relies on mechanical bench testing rather than studies involving expert readers, human performance, or image analysis. Therefore, most of the questions related to these aspects are not applicable or cannot be answered from the provided text.

In summary, this document indicates what types of tests were performed (mechanical), but not the specific acceptance criteria or the detailed results from those tests.

To answer your questions, I would need a different type of document, such as the full test report from the mechanical testing, which would outline the specific criteria and the measured performance data.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The prompt requests "A table of acceptance criteria and the reported device performance," which is not available in the given document.

Summary

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K132559

DEC 3 0 2013 Page 1 of 2

510(k) SUMMARY: MONUMENT™ Spacer

Company: Globus Medical Inc. 2560 General Armistead Avenue. Audubon, PA 19403 (610) 930-1800
Contact: Christina Kichula Group Manager, Regulatory Affairs
August 14, 2013 Date Prepared:

Device Name: MONUMENT ™ Spacers

Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Device Product Code: OVD Regulatory Class: II, Panel Code: 87
Globus Medical INDEPENDENCE® Spacer (K082252 & Predicate(s): K120101)

Purpose:

The purpose of this submission is to request clearance for MONUMENT™ Spacers.

Device Description:

The MONUMENT™ Spacer is made from radiolucent PEEK polymer and titanium alloy, as specified in ASTM F136, F1295, and F2026. The mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.

Indications for Use:

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K132559 Page 2 of 2

patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MONUMENT™ Spacer is to be filled with autogenous bone graft material, and is to be used with four titanium alloy screws that accompany the implant. The device is intended to be used with supplemental fixation (i.e. pedicle screws, facet fixation).

Performance Data:

Mechanical testing (static and dynamic compression, static and dynamic compression shear, subsidence, and expulsion) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM 2267. Performance and comparative analysis data demonstrate that the different technological features do not affect the safety and effectiveness of the device and support substantial equivalence to the predicate devices.

Basis for Substantial Equivalence:

MONUMENT™ Spacers have been found to be substantially equivalent to the predicate with respect to technical characteristics, performance, design, materials, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate device. MONUMENT™ Spacers are as safe, as effective, and perform as well as or better than 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 30, 2013

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

Re: K132559

Trade/Device Name: MONUMENT™ Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: December 4, 2013 Received: December 5, 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 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 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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K132559 Page 1 of 1

Indications for Use Statement

K132559 510(k) Number:

MONUMENT™ Spacers Device Name:

INDICATIONS:

・・・・

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)

David Hwang (dth.D. Division afformopedie 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.