PATRIOT® Spacers (including CONSTITUTION®, SIGNATURE®, CONTINENTAL®, TransContinental®, and TransContinental® M) are interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and had at least six (6) months of non-operative treatment. PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used as thoracolumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R. SUSTAIN®-IR, and SUSTAIN®-RT) are indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc hemiation (with myelopathy), soondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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. SUSTAIN® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous, and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

Device Description

PATRIOT® (including CONSTITUTION®. SIGNATURE®. Spacers TransContinental®, CONTINENTAL®, TransContinental® and M) are thoracolumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the spine. CONSTITUTION® PLIF Spacers are inserted using a posterior or transforaminal approach. SIGNATURE® TLIF Spacers are inserted using a transforaminal or lateral approach. CONTINENTAL® ALIF Spacers are inserted using an anterior, anterolateral, or lateral approach. TransContinental® and TransContinental® M Spacers are inserted using an anterior, anterolateral, or lateral approach. All approaches may be used in the lumbar spine; only anterior, anterolateral, or lateral approaches may be used in the thoracic spine. The devices 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 resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer.

SUSTAIN® Spacers (including SUSTAIN® R, SUSTAIN®-IR, and SUSTAIN®-RT) are devices that can be used as intervertebral fusion devices or as vertebral body replacement devices. When used as interbody fusion devices, each of the spacers provides a different shape to accommodate various surgical approaches to the spine. SUSTAIN Small, SUSTAIN-R, and SUSTAIN-RT Spacers are inserted using a posterior or transforaminal approach. SUSTAIN Arch Spacers are inserted using a transforaminal or lateral approach. SUSTAIN Large Spacers are inserted using an anterior, anterolateral, or lateral approach. SUSTAIN Oblique and SUSTAIN G Spacers are inserted using a posterior, transforaminal, or lateral approach. These 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 resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer.

These spacers are used to provide structural stability in skeletally mature individuals following discectomy, corpectomy, or vertebrectomy (including partial). All approaches may be used in the lumbar spine; only the anterior, anterolateral, or lateral approach may be used in the thoracic spine.

AI/ML Overview

This document describes the premarket notification (510(k)) for two medical devices: PATRIOT® Lumbar Spacers and SUSTAIN® Spacers. It seeks clearance for additional implants and indications for these devices.

Based on the provided text, the acceptance criteria and the study that proves the device meets the acceptance criteria primarily revolve around demonstrating substantial equivalence to already legally marketed predicate devices, rather than a de novo clinical trial with specific performance metrics for the AI component. This is typical for 510(k) submissions for Class II medical devices like intervertebral body fusion devices, where the focus is on a comparison to existing cleared products.

Therefore, the table for "acceptance criteria and reported device performance" will be framed differently than for a typical AI/ML medical device, as the "performance" here is primarily about mechanical and physical characteristics matching predicates, and clinical support comes from literature rather than a new study with specific metrics.

Here's a breakdown of the information requested, as extractable from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on predicate equivalence and relevant standards)	Reported Device Performance (as demonstrated)
Mechanical Performance: - Dynamic Compression - Static Compression - Compression-Shear - Subsidence resistance - Expulsion resistance	Mechanical testing conducted in accordance with: - "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007 - ASTM F2077 (Dynamic and Static Compression and Compression-Shear) - ASTM F2267 (Subsidence) - Expulsion testing Result: Demonstrated substantial equivalence to the predicate spacers.
Technological Characteristics Equivalence: - Design - Intended Use - Material Composition - Range of Sizes	Subject implants have the same technological characteristics as the predicate devices.
Clinical Equivalence for Additional Indications: - Safety and effectiveness for treating disc herniation, spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, or failed previous fusion (pseudarthrosis).	Published clinical data for interbody fusion devices provided. Result: The clinical data demonstrates that the use of interbody fusion devices for these conditions does not pose new risks to patients.

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

This document describes a 510(k) submission based on substantial equivalence and mechanical testing, not a clinical study with a "test set" of patients in the typical sense for AI/ML device validation.

Sample Size for Test Set: Not applicable in the context of a prospective clinical trial. The "testing" referred to is mechanical testing of the devices themselves, on samples of the physical product. The number of samples for these mechanical tests is not specified in the document but would follow the requirements of the ASTM standards.
Data Provenance: The mechanical testing is performed in a lab setting. The clinical support data is "published clinical data" for interbody fusion devices, implying retrospective analysis of existing medical literature. The specific country of origin for this literature is not stated but would typically encompass international studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. For this type of 510(k) submission, ground truth isn't established by expert consensus on a test set of patient cases in the way it is for diagnostic AI. The "ground truth" for mechanical testing is derived from adherence to engineering standards. The rationale for clinical safety and effectiveness for new indications relies on a review of existing clinical literature by the manufacturer and the FDA.
Qualifications of Experts: Not applicable in this context. The FDA's review committee would consist of qualified experts in orthopedic devices.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This wasn't a clinical test set requiring adjudication of patient cases.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission does not involve an AI component that assists human readers.

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

Standalone Study: Not applicable. This device is an intervertebral body fusion device, not a software algorithm.

7. The Type of Ground Truth Used

Ground Truth:
- For Mechanical Performance: Engineering standards (e.g., ASTM F2077, ASTM F2267) define the "ground truth" for mechanical properties and performance.
- For Clinical Efficacy/Safety: Published clinical literature and established medical understanding of interbody fusion devices (for the new indications) serve as the "ground truth" for safety and effectiveness.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set. The "training" in the context of device development would involve engineering design, prototyping, and iterative mechanical testing, not data-driven machine learning.

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

Ground Truth for Training Set: Not applicable. As there is no AI/ML component, there's no "training set" or establishment of ground truth for such a set in the machine learning sense.

Summary

{0}------------------------------------------------

December 6, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Globus Medical Inc. Kelly Baker, PhD Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403

Re: K181357

Trade/Device Name: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM Dated: November 2, 2018 Received: November 5, 2018

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Melissa Hall -S

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181357

Device Name PATRIOT® Lumbar Spacers

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.### This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and comblete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

PSC Publishing Scrvices (301) 443-6740

{3}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181357

Device Name SUSTAIN® Spacers

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------------------	------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary: PATRIOT® Lumbar Spacers and SUSTAIN® Spacers

Company: Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 610-930-1800
Contact: Kelly Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
Date Prepared: December 4, 2018

Device Name: PATRIOT® Lumbar Spacers SUSTAIN® Spacers

Common Name: Intervertebral Body Fusion Device
Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Device Product Code(s): MAX, PHM Regulatory Class: II, Panel Code: 87
Primary Predicate: PATRIOT® Spacers (Lumbar) (K072970)

Additional

Predicates: PATRIOT® Spacers (Lumbar) (K093242, K102313, K122097, K143578, K152022, K161223) SUSTAIN® R Spacers (K130478, K143578, K151665, K152022) CALIBER® Spacers (K123231) NuVasive CoRoent Thoracolumbar System (K170962) Stryker Spine AVS Navigation PEEK Spacer (K100865) Medtronic CRESCENT Spinal System (K171031)
Reference Device: DePuy Synthes SYNFIX Lateral (K131276)

Purpose:

The purpose of this submission is to request clearance for additional implants and indications for the PATRIOT and SUSTAIN spacers.

Device Description:

PATRIOT® Spacers

{5}------------------------------------------------

skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the spine. CONSTITUTION® PLIF Spacers are inserted using a posterior or transforaminal approach. SIGNATURE® TLIF Spacers are inserted using a transforaminal or lateral approach. CONTINENTAL® ALIF Spacers are inserted using an anterior, anterolateral, or lateral approach. TransContinental® and TransContinental® M Spacers are inserted using an anterior, anterolateral, or lateral approach. All approaches may be used in the lumbar spine; only anterior, anterolateral, or lateral approaches may be used in the thoracic spine. The devices 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 resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer.

SUSTAIN® Spacers

Indications for Use:

PATRIOT® Spacers

{6}------------------------------------------------

of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

SUSTAIN® Spacers

When used as thoracolumbar intervertebral body fusion devices. SUSTAIN® Spacers (including SUSTAIN® R, SUSTAIN®-IR, and SUSTAIN®-RT) are indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: deqenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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. SUSTAIN® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

Performance Data:

Mechanical testing was conducted with the additional implants in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077 (Dynamic and Static Compression and Compression-Shear) and ASTM F2267 (Subsidence), and expulsion testing was conducted to demonstrate substantial equivalence to the predicate spacers.

Clinical Literature:

Published clinical data for interbody fusion devices is provided in this submission to support the additional indications for multiple levels in the thoracolumbar spine. The clinical data demonstrates that the use of interbody fusion devices to treat patients with disc herniation, spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis or failed previous fusion (pseudarthrosis) does not pose new risks to patients.

{7}------------------------------------------------

Technological Characteristics:

Subject implants have the same technological characteristics as the predicate devices including design, intended use, material composition, and range of sizes.

Basis of Substantial Equivalence:

Subject spacers have been found to be substantially equivalent to the predicate devices 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.

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.