The SI-LOK® Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

Device Description

The SI-LOK® Sacroiliac Joint Fixation System (including SI-LOK® Select) consists of cannulated, fully or partially threaded screws that are available with or without slots and optional pre-assembled contouring washers. One, two or three screws may be placed in one sacroiliac joint, depending on the approach.

The screws and washers are manufactured from titanium alloy, as specified in ASTM F136 (Ti6Al4V) and F1295 (Ti6Al7Nb). SI-LOK® screws are available with or without hydroxyapatite (HA) coated, as specified in ASTM F1185.

SI-LOK® Sacroiliac Joint Fixation System include surgical instruments manufactured from stainless steel, as specified in ASTM F899.

SI-LOK® ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be operated with the ExcelsiusGPS® robotic arm, or may be used for a freehand navigated surgical procedure.

SI-LOK® Navigation Instruments are nonsterile, reusable instruments that can be operated manually or under power using a power drill such as POWEREASE that are intended to be used with the Medtronic StealthStation® System.

AI/ML Overview

This FDA 510(k) K183119 summary does not describe a study involving device performance metrics related to diagnostic accuracy, sensitivity, specificity, or reader studies utilizing AI. Instead, it focuses on the substantial equivalence of the "SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments" to previously cleared predicate devices based on mechanical, biocompatibility, and technological characteristics.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from the provided text. The device in question is a surgical fixation system and related navigation instruments, not an AI-powered diagnostic or assistive tool in the typical sense for which an MRMC study or standalone algorithm performance metrics would be assessed.

Here's a breakdown of what can be extracted based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of accuracy metrics for an AI system. Instead, the "acceptance criteria" are implied through the successful completion of specified mechanical and biocompatibility tests, demonstrating substantial equivalence to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
Static Cantilever Bending	Performed in accordance with ASTM F2193 and ASTM F543 to demonstrate substantial equivalence to predicate devices.
Dynamic Cantilever Bending	Performed in accordance with ASTM F2193 and ASTM F543 to demonstrate substantial equivalence to predicate devices.
Screw Pull-Out	Performed in accordance with ASTM F543 to demonstrate substantial equivalence to predicate devices.
Biocompatibility:
Material Biocompatibility	Demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices.
Bacterial Endotoxin Testing (BET)	Conducted in accordance with ANSI/AAMI ST-72:2011.
Accuracy (Navigation Instruments):	Accuracy testing performed on the predicate Navigation instruments is applicable for the subject instruments and has not been repeated.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in terms of human subjects or diagnostic cases, as this is primarily a mechanical and material performance evaluation for a surgical device. The "sample size" would refer to the number of devices or components tested in the mechanical evaluations, which is not detailed.
Data Provenance: Not applicable in the context of diagnostic data. The provenance for the device materials and testing standards is US (ASTM, ANSI/AAMI).

3. 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 in the context of device performance in this submission refers to adherence to mechanical and material standards, not expert medical opinion on diagnostic images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no adjudication process involving expert readers described.

5. 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

No MRMC comparative effectiveness study was done or described. This submission is not for an AI-assisted diagnostic device. The ExcelsiusGPS® and Navigation Instruments are tools to assist surgeons in locating anatomical structures and positioning instruments, often used with imaging but not as a primary diagnostic AI.

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

Not applicable. This device is not a standalone algorithm. Its function is to aid a human surgeon.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's substantial equivalence is based on:

Engineering standards (ASTM F2193, ASTM F543, ANSI/AAMI ST-72:2011) for mechanical and biocompatibility properties.
Comparison of technological characteristics (design, intended use, material composition, function, range of sizes) to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI model.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration written in blue text.

February 6, 2019

Globus Medical Inc. Ms. Lori Burns Director. Regulatory Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K183119

Trade/Device Name: SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR, OLO Dated: November 8, 2018 Received: November 9, 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/cfpmp/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

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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 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.

Ronald P. Jean -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) K183119

Device Name

SI-LOK® Sacroiliac Joint Fixation System

Indications for Use (Describe)

The SI-LOK® Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis.

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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K183119

Device Name Navigation Instruments

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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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.

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."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K183119

Device Name ExcelsiusGPS®

Indications for Use (Describe)

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

Residential (Part 51.077.001.A.1, subpart B)	Commercial
-----------------------------------------------------------------------------------------------------	----------------------------------------------------

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.

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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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510(k) Summary: SI-LOK® Additional Implants and Instruments

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Contact:	Lori BurnsDirector, Regulatory Affairs
Date Prepared:	November 8, 2018
Device Name:	SI-LOK® Sacroiliac Joint Fixation SystemNavigation InstrumentsExcelsiusGPS® Instruments
Common Name:	Sacroiliac Joint Fusion SystemNavigation Instruments
Classification:	SI-LOK® Sacroiliac Joint Fixation SystemPer 21 CFR as follows:§888.3040: Smooth or threaded metallic bone fixationfastenerProduct Code: OURRegulatory Class: II, Panel Code: 87Navigation InstrumentsPer 21 CFR as follows:§882.4560 Stereotaxic InstrumentsProduct Code OLORegulatory Class: II, Panel Code: 84ExcelsiusGPS® InstrumentsPer 21 CFR as follows:§882.4560 Stereotaxic InstrumentsProduct Codes OLORegulatory Class: II, Panel Code: 87
Primary Predicate:	SI-LOK® Sacroiliac Joint Fixation System (K112028)
AdditionalPredicates:	Synthes Cannulated Screw System (K962011, K021932)Medtronic RIALTO (K161210)

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SI-LOK® ExcelsiusGPS® Instruments ExcelsiusGPS® (K171651)

SI-LOK® Navigation Instruments Navigation Instruments (K153203, K180690)

Purpose:

The purpose of this submission is to request clearance of additional SI-LOK® Select implants, ExcelsiusGPS® Instruments, and Navigation Instruments.

Device Description:

SI-LOK® Sacroiliac Joint Fixation System include surgical instruments manufactured from stainless steel, as specified in ASTM F899.

SI-LOK® ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be operated with the ExcelsiusGPS® robotic arm, or may be used for a freehand navigated surgical procedure.

Indications for Use:

SI-LOK® Sacroiliac Joint Fixation System

The SI-LOK® Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

ExcelsiusGPS® Instruments

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

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Navigation Instruments

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO® REVERE®, REVOLVE®, ELLIPSE®, PROTEX®-CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

Performance Data:

Mechanical testing, including static and dynamic cantilever bending and screw pull-out, were conducted in accordance with ASTM F2193 and ASTM F543 to demonstrate substantial equivalence of the subject SI-LOK Select implants to the predicate devices. Accuracy testing performed on the predicate Navigation instruments is applicable for the subject instruments and has not been repeated. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011. Biocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices.

Technological Characteristics:

Subiect SI-LOK® Select implants. ExcelsiusGPS® instruments. and Navigation instruments have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes,

Basis of Substantial Equivalence:

The subject SI-LOK® implants and instruments are similar to the predicate devices with respect to technological characteristics, performance, design, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.