FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5). FORTIFY® Spacers (titanium) are also intended for use in the cervical spine (C2-T1). All FORTIFY® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used in the cervical spine (C2-T1), FORTIFY® devices (titanium) are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), FORTIFY® Integrated devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

Device Description

FORTIFY® Corpectomy Spacers are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The spacers include a central core and endplates, which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and the endplates can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autogenous bone graft or allograft comprised of cancellous or corticocancellous bone graft to be packed inside of the spacer. Protrusions (teeth) on the superior and inferior surface grips the endplate of the adjacent vertebrae to resist expulsion. FORTIFY® Variable Angle endplates provide adjustable lordosis/kyphosis.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "FORTIFY® Corpectomy Spacers." This document is focused on demonstrating the substantial equivalence of a new version of the device (with variable angle endplates) to previously cleared predicate devices.

It's crucial to understand that a 510(k) submission for a spinal implant device like this is primarily based on demonstrating mechanical and material equivalence to a predicate device, not on clinical performance metrics or AI algorithm validation. The questions you've asked (about acceptance criteria, AI performance studies, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) are typical for the validation of Artificial Intelligence/Machine Learning (AI/ML) based medical devices, especially those involved in image analysis or diagnostic support.

Therefore, based on the provided text, I cannot answer your specific questions related to AI/ML device validation. The information provided by the FDA for this particular 510(k) focuses on the mechanical and material aspects of the physical implant.

Here's a breakdown of why your specific questions cannot be answered from this document:

No AI Component: The device described, FORTIFY® Corpectomy Spacers, is a physical spinal implant. It does not appear to involve any AI/ML components for image analysis, diagnosis, or treatment planning.
Performance Data Type: The "Performance Data" section explicitly states: "Mechanical testing (static and dynamic compression, static and dynamic torsion, and expulsion) was conducted in accordance with ASTM F2077 and 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011." This confirms the performance data is related to the physical properties and biocompatibility of the implant, not to the performance of an AI algorithm.
Focus on Substantial Equivalence: The entire submission's purpose is to show "substantial equivalence" to existing physical devices, meaning it works similarly, has similar indications, and performs mechanically as well as the predicate. This is a common pathway for new versions of existing medical devices and does not typically involve clinical trials or AI validation studies.

In summary, the provided document is for a traditional physical medical device and therefore does not contain the information requested about AI acceptance criteria and validation studies.

If you have a document describing an AI/ML medical device, please provide that, and I would be able to address your questions.

Summary

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September 19, 2018

Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Globus Medical Inc. Lori Burns Director, Regulatory Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403

Re: K173982

Trade/Device Name: FORTIFY® Corpectomy Spacers Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP, PLR Dated: August 20, 2018 Received: August 21, 2018

Dear Ms. Burns:

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 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

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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,

Brent Showalter -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K173982

Device Name FORTIFY® Corpectomy Spacers

Indications for Use (Describe)

The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

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

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510(k) Summary: FORTIFY® Additional Implants

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

Contact: Lori Burns Director, Regulatory Affairs

September 17, 2018 Date Prepared:
Device Name: FORTIFY® Corpectomy Spacers
Classification: Per 21 CFR as follows: §888.3060 Spinal Intervertebral Fixation Orthosis Product Code(s) : MQP, PLR Regulatory Class II, Panel Code 87.

Primary Predicate: FORTIFY® Corpectomy Spacers (K162315)

AdditionalPredicates:	FORTIFY® Corpectomy Spacers (K112756)XPAND® Corpectomy Spacer (K050850)
ReferenceDevices:	INDEPENDENCE MIS AGX (K170157)Synthes SynMesh (K003275)MR Compatibility (K171848)PEEK Vendor (K152022)

Purpose:

The purpose of this submission is to request clearance for additional FORTIFY® implants consisting of variable angle endplates.

Device Description:

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Indications for Use:

When used in the cervical spine (C2-T1), FORTIFY® devices (titanium) are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), FORTIFY® and FORTIFY® Integrated devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

Performance Data:

Mechanical testing (static and dynamic compression, static and dynamic torsion, and expulsion) was conducted in accordance with ASTM F2077 and "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

Technological Characteristics:

FORTIFY® additional implants have similar technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.

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Basis of Substantial Equivalence:

FORTIFY® additional implants 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 implants to the predicate device.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.