K Number

Device Name

Manufacturer

GLOBUS MEDICAL INC.

Date Cleared

2011-01-05

(145 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K072970,K093242,K080537

Intended Use

CALIBER™ Spacers are interbody fusion devices 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 non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

CALIBER™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE® or REVOLVE™ Stabilization Systems.

Device Description

CALIBER™ Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. CALIBER™ Spacers are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral) or lateral) and can expand to the desired height. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers 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.

CALIBER™ Spacers are manufactured from radiolucent PEEK polymer and titanium alloy per ASTM F2026, F136 and F1295; non-expanding CALIBER™ Spacers are manufactured from PEEK only. CALIBER™ Spacers contain radiopaque titanium alloy or tantalum markers as specified in ASTM F136, F1295 and F560.

AI/ML Overview

The CALIBER™ Spacer is a medical device and as such, the provided text does not describe acceptance criteria and studies in the context of an AI/ML device that would typically involve metrics such as sensitivity, specificity, or reader studies. Instead, it describes mechanical testing for a spinal implant to demonstrate substantial equivalence to predicate devices for regulatory clearance.

However, interpreting the request in the context of the provided information, I will extract relevant details regarding the device's performance evaluation and regulatory acceptance.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Mechanical Performance	Static compression	Testing conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007, and ASTM F2077. Performance demonstrated substantial equivalence to predicate system(s).
	Dynamic compression	Testing conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007, and ASTM F2077. Performance demonstrated substantial equivalence to predicate system(s).
	Static compression-shear	Testing conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007, and ASTM F2077. Performance demonstrated substantial equivalence to predicate system(s).
	Dynamic compression-shear	Testing conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007, and ASTM F2077. Performance demonstrated substantial equivalence to predicate system(s).
	Subsidence	Testing conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007, and ASTM F2077. Performance demonstrated substantial equivalence to predicate system(s).
Substantial Equivalence	Comparison to predicate systems with respect to technical characteristics, performance, and intended use.	The device was found substantially equivalent to predicate devices (Globus PATRIOT® Spacers (K072970 & K093242) and Kiscomedica L-Varlock™ Lumbar Cages (K080537)) based on mechanical testing and similar technical characteristics, performance, and intended use.

Additional Information (Not applicable for this type of medical device submission):

The provided document is a 510(k) summary for a medical device (CALIBER™ Spacer), which is a physical implant, not an AI/ML software device. Therefore, many of the requested fields are not relevant to this type of regulatory submission. The submission focuses on demonstrating the device's mechanical integrity and substantial equivalence to existing, legally marketed predicate devices, not on the performance of a diagnostic algorithm or AI model.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for mechanical testing of a physical implant. The test set would consist of physical samples of the device undergoing stress. The document does not specify the number of samples used for each test.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus on medical images.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are for clinical or image-based evaluations.
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 a physical device, not an AI tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by established engineering standards (ASTM F2077) and regulatory guidance ("Class II Special Controls Guidance Document: Intervertebral Fusion Device"). The device's performance is measured against these established physical and mechanical benchmarks.
The sample size for the training set: Not applicable. This refers to the training of an AI model, not the development or testing of a physical implant.
How the ground truth for the training set was established: Not applicable.

Summary

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1102293

page 1 of 2

510(k) Summary: CALIBER™ Spacer

JAN	- 5	2011
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Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403(610) 930-1800
Contact:	Kelly J. Baker, Ph.DDirector, Clinical Affairs & Regulatory

Date Prepared: August 12, 2010

Device Name: CALIBER™ Spacer

Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion device. Product Code MAX. Regulatory Class II, Panel Code 87
Globus PATRIOT® Spacers (K072970 & K093242) Predicate(s): Kiscomedica L-Varlock™ Lumbar Cages (K080537)

Purpose:

The purpose of this submission is the addition of CALIBER™ Spacers to the PATRIOT® Lumbar Spacers.

Device Description:

Indications for Use:

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page 2 of 2

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).

CALIBER™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE® or REVOLVE™ Stabilization Systems.

Performance Data:

Mechanical testing consisting of static and dynamic compression, static and dynamic compression-shear and subsidence 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 system(s).

Basis for Substantial Equivalence:

CALIBER™ Spacers 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 device(s).

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

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

Globus Medical Inc. % Kelly J. Baker, Ph.D. Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403

JAN - 5 2011

Re: K102293

Trade/Device Name: CALIBER™ Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 28, 2010 Received: December 29, 2010

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. 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

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Page 2 – Kelly J. Baker, Ph.D.

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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 Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

JAN - 5 2011

KID2293 510(k) Number:

Device Name: CALIBER™ Spacer

Indications:

CALIBER™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE® or REVOLVE™ Stabilization Systems.

Prescription Use OR Over-The-Counter Use × (Per 21 CFR §801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIO 2293 510(k) Number_

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.