The PATRIOT® TransContinental™ M 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). The PATRIOT® TransContinental™ M Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

Device Description

The PATRIOT® TransContinental® M Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The spacers are inserted using an anterior or lateral approach to the lumbar spine. The PATRIOT® TransContinental® M implants 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. PATRIOT® TransContinental™ M Spacers are made from PEEK radiolucent polymer, with an integrated titanium alloy nut and titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the PATRIOT® TransContinental™ M Spacer, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) summary for a medical device (an intervertebral body fusion device) seeking substantial equivalence. The "acceptance criteria" discussed in this context are not typically for an AI/ML diagnostic device's performance metrics (like sensitivity/specificity), but rather for the physical, mechanical, and biological properties of the implant itself, demonstrating that it is as safe and effective as a predicate device.

Description of Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The PATRIOT® TransContinental™ M Spacer is an interbody fusion device. Its acceptance criteria and the study proving it meets them are focused on demonstrating that the new device is "substantially equivalent" to previously cleared predicate devices in terms of its design, materials, and mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Performance: - Static Compression - Dynamic Compression - Static Compression-Shear - Dynamic Compression-Shear - Subsidence	"Mechanical testing (static and dynamic compression, static and dynamic compression-shear, and subsidence) was conducted in accordance with ASTM F2077 and F2267, the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004, and 'Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device', June 12, 2007. Performance data demonstrate substantial equivalence to the predicate device."
Material Composition and Biocompatibility: - PEEK radiolucent polymer conformance - Titanium alloy conformance - Tantalum conformance	"PATRIOT® TransContinental™ M Spacers are made from PEEK radiolucent polymer, with an integrated titanium alloy nut and titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560." (Note: ASTM standards imply specific material properties and often biocompatibility requirements)
Design and Indications for Use Similarity to Predicate Device	"The PATRIOT® TransContinental™ M Spacers are similar to the predicate systems with respect to technical characteristics, performance and intended use."
Pre-clinical Testing Conformity	The device was tested according to relevant ASTM standards (F2077, F2267) and FDA guidance documents for spinal systems and intervertebral fusion devices. This implies conformity to established safety and performance benchmarks for spinal implants.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in the summary. For mechanical testing of medical implants, the "sample size" refers to the number of physical devices or material specimens tested. These are generally small, statistically determined samples to ensure robust testing for design verification and validation.
Data Provenance: The data is generated from in vitro mechanical testing studies performed under controlled laboratory conditions, not from human patient data. Therefore, notions of "country of origin" or "retrospective/prospective" do not apply.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable in the context of this 510(k) summary. "Ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F2077, F2267) and the results obtained from the tests themselves, measured by calibrated equipment. There is no human interpretation or expert consensus involved in establishing the "ground truth" for the mechanical performance of the device in this context. The experts involved would be the engineers and technicians conducting the testing and interpreting the results against established standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are used for interpreting ambiguous human-read data (e.g., medical images). Here, the "test set" consists of mechanical performance data, which is objectively measured and compared against predefined criteria (ASTM standards, FDA guidance).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices where human readers evaluate cases with and without AI assistance. The PATRIOT® TransContinental™ M Spacer is a physical implant, not a diagnostic AI tool, so this type of study is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

No, a standalone performance study was not done. This concept also applies to AI/ML diagnostic algorithms. This device is a passive implant; its "performance" is mechanical stability and biological integration, not diagnostic accuracy.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established engineering standards (ASTM F2077, F2267) and FDA guidance documents for the mechanical properties and material specifications of intervertebral body fusion devices. The device is expected to meet or exceed the performance benchmarks defined by these standards, demonstrating equivalence to already-cleared devices.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML "training set" associated with the development or testing of this type of passive medical implant. The design of the device is based on engineering principles, material science, and anatomical considerations, not machine learning from a dataset.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set in this context.

Summary

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510(k) SUMMARY: PATRIOT® TransContinental™ M Spacer

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 13, 2010
Device Name:	PATRIOT® TransContinental™ M Spacer
Classification:	Per 21 CFR as follows:§888.3080 Intervertebral Body Fusion DeviceProduct Code MAX.Regulatory Class II, Panel Code 87
Predicate(s):	PATRIOT® Lumbar Spacers K072970

PATRIOT® Lumbar Spacer SE date January 18, 2008 PATRIOT® TransContinental LLIF Spacers K093242 SE date December 23, 2009

Purpose:

The purpose of this submission is clearance of the PATRIOT® TransContinental® M Spacer, a component of the PATRIOT® family of lumbar interbody fusion spacers.

Device Description:

PATRIOT® TransContinental™ M Spacers are made from PEEK radiolucent polymer, with an integrated titanium alloy nut and titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.

Indications for Use:

more TransContinental™ M Spacers are interbody fusion devices intended I ATRIOT Transoonlinental - m extient disc disease (DDD) at one or two for use in patients with degeneral spine (L2-S1). DDD is defined as

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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).

The PATRIOT® TransContinental™ M Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

Performance Data:

Mechanical testing (static and dynamic compression, static and dynamic compression-shear, and subsidence) was conducted in accordance with ASTM F2077 and F2267, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004, and "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007. Performance data demonstrate substantial equivalence to the predicate device.

Basis for Substantial Equivalence:

The PATRIOT® TransContinental™ M 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 to the predicate device(s).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three wing-like shapes, positioned to the right of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

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. Director, Clinical Affairs and Regulatory Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403

DEC - 3 2010

Re: K102313

Trade/Device Name: PATRIOT® TransContinental™ M Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 29, 2010 Received: November 30, 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 Mav 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. Ilsting 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.

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

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 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.hym 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

For Peter
Mark N. Melkerson

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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K102313

Indications for Use Statement

DEC - 3 2010

510(k) Number:

PATRIOT® TransContinental™ M Spacer Device Name:

Indications:

The PATRIOT® TransContinental™ M Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

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)

Division Sign-Off

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

K102313 510(k) Number_

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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.