The ExcelsiusGPS is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous 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 and interbody spacers, and intracranial devices including biopsy needles, electrodes, and tubes.

Device Description

The ExcelsiusGPS® Cranial Module includes hardware and software that enables real time surgical navigation using radiological patient images (MRI, CT, and fluoroscopy), using a dynamic reference base and positioning camera. The navigation system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy). Once this registration is created, the software displays the relative position of a tracked instrument on the patient images. As an aid to visualization, the surgeon can plan trajectories for instrument placement on the patient images prior to surgery. Registration provides the necessary information to provide visual assistance to the surgeon during freehand navigation. During surgery, the system tracks the position of GPS compatible instruments in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. System software is responsible for all navigation functions, data storage, network connectivity, user management, case management, and safety functions. ExcelsiusGPS® surgical instruments include non-sterile, re-usable instruments and sterile instruments that are operated manually or with the use of the positioning system.

The ExcelsiusGPS® Cranial Module is designed to assist with stereotactic procedures that include guidance to cranial targets for instrument navigation and device placement. Instruments consist of end effector instruments, registration instruments, navigated instruments, patient positioning instruments, and surgical instruments. End effector instruments include instruments to the Interchangeable Guide End Effector. Registration and navigated instruments incorporate unique array patterns with reflective markers, and are used to track patient anatomy and surgical instruments. Patient positioning instruments aid in patient fixation. Surgical instruments are used to access and prepare the local site and place devices, such as needles, electrodes, and tubes.

AI/ML Overview

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

Metric	Acceptance Criteria	Reported Device Performance
Position	< 1.5mm (Mean)	Not explicitly stated as a single value for mean, but 99% CI is ≤ 2mm.
Position	≤ 2mm (99% CI)	≤ 2mm
Angle	< 2.0° (Mean)	Not explicitly stated as a single value for mean, but 99% CI is ≤ 2°.
Angle	≤ 2° (99% CI)	≤ 2°

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

The document does not explicitly state the specific sample size for the "human cadaveric quantitative validation" study or the "surgical simulations conducted on phantom models cranial sawbone models." It mentions "phantom models cranial sawbone models" and "human cadaveric quantitative validation under clinically relevant scenarios." The provenance of the data (country of origin, retrospective/prospective) is not specified.

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)

This information is not provided in the document.

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

The document does not describe any adjudication method for establishing ground truth or evaluating device performance.

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 involving human readers and AI assistance is mentioned in the provided text. The device is a computer-assisted surgical system, not an AI diagnostic tool that assists human readers.

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

The performance testing described (navigational accuracy) appears to be a standalone assessment of the algorithmic/system accuracy for position and angle. The device itself is described as a "computer-assisted surgical device" that provides "real-time surgical navigation" and "visual assistance to the surgeon," implying that the reported accuracy values relate to the algorithm's ability to track and guide instruments.

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

For the "surgical simulations conducted on phantom models cranial sawbone models," the ground truth was likely derived from the known physical properties and measurements of these models. For the "human cadaveric quantitative validation," the ground truth would typically be established by precise physical measurements of the actual position and angle of instruments relative to anatomical landmarks on the cadaver, using highly accurate measurement tools independent of the device under test. The document does not specify the exact method for establishing this ground truth.

8. The sample size for the training set

This information is not provided in the document. The document describes verification and validation testing, but not details about a training set for machine learning models.

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

Since no training set information is provided, the method for establishing its ground truth is also not mentioned.

Summary

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July 10, 2020

Globus Medical Inc. Jennifer Antonacci Group Manager, Regulatory Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403

Re: K200047

Trade/Device Name: ExcelsiusGPS Cranial 1.0 Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, HAW Dated: June 11, 2020 Received: June 12, 2020

Dear Jennifer Antonacci:

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200047

Device Name ExcelsiusGPS Cranial 1.0 Module

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)

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510(k) Summary: ExcelsiusGPS Cranial 1.0 Module

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Primary Contact:	Jennifer Antonacci, Ph.D.Group Manager, Regulatory Affairs
Date Prepared:	July 10, 2020
Device Name:	ExcelsiusGPS® Cranial 1.0 Module
Common Name:	Computer-assisted surgical device

Classification: Per 21 CFR as follows: §882.4560 Stereotaxic instrument Product Code(s): OLO, HAW Regulatory Class: II
Primary Predicate: ExcelsiusGPS® (K171651)
Other Predicates: ExcelsiusGPS® Spine 1.1 Interbody Module (K191100) Medtronic StealthStation S8 (K162309) ROSA ONE Brain (K182417)

Purpose:

The purpose of this submission is to request clearance of the ExcelsiusGPS® Cranial 1.0 Module software and navigated instruments for access, preparation, and placement of cranial devices.

Device Description:

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navigation functions, data storage, network connectivity, user management, case management, and safety functions. ExcelsiusGPS® surgical instruments include non-sterile, re-usable instruments and sterile instruments that are operated manually or with the use of the positioning system.

The ExcelsiusGPS® Cranial Module is designed to assist with stereotactic procedures that include quidance to cranial targets for instrument navigation and device placement. Instruments consist of end effector instruments, registration instruments, navigated instruments, patient positioning instruments, and surgical instruments. End effector instruments include instruments to the Interchangeable Guide End Effector. Registration and navigated instruments incorporate unique array patterns with reflective markers, and are used to track patient anatomy and surgical instruments. Patient positioning instruments aid in patient fixation. Surgical instruments are used to access and prepare the local site and place devices, such as needles, electrodes, and tubes. The ExcelsiusGPS® Cranial Module is suitable for use in adult and pediatric patient populations in which the use of stereotactic neurosurgery may be appropriate.

Indications for Use:

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or quide tube to be used by surgeons for navigating and/or quiding compatible surqical 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 and interbody spacers, and intracranial devices including biopsv needles, electrodes, and tubes.

Technological Characteristics:

The ExcelsiusGPS® Cranial Module and associated instruments have similar technological characteristics to the predicate devices including the main system components, workflow, user interface, software features, and design. The ExcelsiusGPS® Cranial Module is comparable to the predicates in terms of intended use, fundamental scientific technology, technological characteristics and principle of operation.

Device	SubjectExcelsiusGPS®Cranial Module	PredicateExcelsiusGPS®(K171651, K191100)	PredicateStealthStation S8(K162309)	PredicateROSA ONE Spine(K182417)
Principle ofoperation	- Intraoperative/preoperativeimages- Patient registration- Surgical planning- Real-time trackingof navigatedinstruments	- Intraoperative/preoperativeimages- Patient registration- Surgical planning- Real-time trackingof navigatedinstruments	- Intraoperative/preoperativeimages- Patientregistration- Surgical planning	- Intraoperative/preoperativeimages- Patient registration- Surgical planning- Guidance ofinstruments
Device	SubjectExcelsiusGPS®Cranial Module	PredicateExcelsiusGPS®(K171651, K191100)	PredicateStealthStation S8(K162309)	PredicateROSA ONE Spine(K182417)
	- Guidance ofinstruments	- Guidance ofinstruments	- Real-time trackingof navigatedinstruments
Input images	3D preoperativeexam3D intraoperativeexam2D intraoperativeexam	3D preoperativeexam3D intraoperativeexam2D intraoperativeexam	3D preoperativeexam3D intraoperativeexam2D intraoperativeexam	3D preoperativeexam3D intraoperativeexam2D intraoperativeexam
Integratedplanningsoftware	ExcelsiusGPS®Planning andNavigationApplication Software	ExcelsiusGPS®Planning andNavigationApplication Software	StealthstationCranial	ROSANNA BRAIN
Save/loadplanning	Yes	Yes	Yes	Yes
Merge imagesfunctionality	Yes	Yes	Yes	Yes
Image-guided	Yes	Yes	Yes	Yes
Patientregistrationmethod	Intra-Op CT:RegistrationFixtureFluoroscopy:RegistrationFixtureStereotacticLocalizerRegistration	Intra-Op CT:RegistrationFixturePre-Op CT:Fluoroscopic toPre-Op CT MergeFluoroscopy:RegistrationFixture	Point-to-pointregistration withanatomicalmarkers orskin/bonefiducialsOptical orelectromagnetictrace mergeIntra-Op CT:Calibrated CTgantry to cameramergeStereotacticLocalizerRegistration	Point-to-pointregistration withanatomical markersor skin/bonefiducialsStereotactic LocalizerRegistrationOptical surfaceregistration
Accuracyverification onanatomicallandmarks	Yes	Yes	Yes	Yes
Real timedisplay ofinstrumentposition	Yes	Yes	Yes	Yes
Patientfixation	Reference isattached to patienthead holder- Head is fixed topatient stabilizationstand	Reference is fixed topatient's bonystructure such as along bone, iliaccrest, spinousprocess, vertebra,etc. for trackingsystem	Reference isattached to patienthead holder	Head is fixed ontorobot arm's flange

Comparison of Principles of Operation and Technological Characteristics

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Performance Testing:

Verification and validation testing was conducted on ExcelsiusGPS® Cranial Module to confirm that the device meets performance requirements under the indications for use and to ensure safety and efficacy of the system:

Non-clinical system, software, and instrument verification and validation -● demonstrated compliance with user needs and corresponding design inputs
Surgical simulations conducted on phantom models cranial sawbone . models and registration matrix were used to quantify accuracy in a controlled setting
Human cadaveric quantitative validation under clinically relevant scenarios - demonstrated system accuracy in navigating cranial devices to the desired location on patient images
. Compliance conformity assessments per:
- o IEC 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012
- o IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General Requirements for Basic Safety and Essential Performance - Usability
Navigational accuracy of the subject device system with mean, standard . deviation, and 99% confidence interval (CI). Results demonstrate the subject device meets the accuracy acceptance criteria for position and angle as follows:

Position		Angle
Mean	99% CI	Mean	99% CI
< 1.5mm	≤ 2mm	< 2.0°	≤ 2°

Biocompatibility:

The biocompatibility evaluation for ExcelsiusGPS® has been conducted in accordance with FDA Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process'," June 16, 2016. The evaluation confirms that ExcelsiusGPS® meets biocompatibility requirements.

Electrical Safety and Electromaqnetic Compatibility:

Testing was performed to assure compliance with recognized safety standard: IEC 60601-1:2012 standard for electrical safety. Electromagnetic compatibility was not affected.

Software Verification and Validation Testing:

Software validation and verification testing was performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). The software for this device is considered a "MAJOR" level of concern.

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Basis of Substantial Equivalence:

ExcelsiusGPS® Cranial Module has 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 to the predicate devices.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).