The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating 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 and interbody fusion devices.

Device Description

The ExcelsiusHub™ is a navigation system that includes hardware and software that enables real time surgical visualization using radiological patient images (preoperative CT, intraoperative CT and fluoroscopy), a dynamic reference base, and a camera tracking system. 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 reqistration is created, the software displays the relative position of a tracked instrument on the patient images. This visualization can help guide the surgeon's planning and approach for implant placement. The patient's scan coupled with the reqistration provides visual assistance to the surgeon when using the system for free hand navigation. During surgery, the system tracks the position of 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. ExcelsiusHub™ uses the same instruments as ExcelsiusGPS®.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ExcelsiusHub™ device, based on the provided text:

Executive Summary: The provided 510(k) summary does not include detailed quantitative acceptance criteria or a specific study that directly proves the device meets those criteria for clinical accuracy. Instead, it mentions "Verification and validation testing" and "Surgical simulations conducted on phantom models" without providing metrics or results. The focus is on demonstrating substantial equivalence to predicates through similar technological characteristics and general performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Critique: The provided document does not include specific quantitative acceptance criteria (e.g., "accuracy must be within X mm") or a table showing the device's reported performance against such criteria. It states that "Verification and validation testing were conducted... to confirm that the device meets performance requirements." However, the actual performance requirements (acceptance criteria) and the results against them are not detailed.

Therefore, this section cannot be fully constructed from the provided text.

2. Sample Size for the Test Set and Data Provenance

Critique: The document states that "Surgical simulations conducted on phantom models" were performed. However, it does not specify:

The sample size (number of phantom models or surgical procedures simulated).
The data provenance (e.g., country of origin, retrospective or prospective). Phantom studies typically don't have a "country of origin" in the same way clinical data does, but the specifics of the phantom models and the simulation environment (e.g., in-house testing facility) are missing.
Whether human data was used for a test set. The mention of "phantom models" strongly suggests laboratory testing rather than human clinical trials for direct performance evaluation.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Critique: Since the document mentions "Surgical simulations conducted on phantom models" and not human studies for the primary performance evaluation, the concept of "experts used to establish ground truth" in the clinical sense (e.g., radiologists assessing images) is not directly applicable or described. If the phantom studies involved expert assessment of outcomes, this is not detailed.

4. Adjudication Method for the Test Set

Critique: No information is provided regarding an adjudication method. This would typically be relevant for studies involving human assessment or complex clinical endpoints, which are not described here for performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Critique: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, there is no information on the effect size of human readers improving with AI vs. without AI assistance. The device is a navigation system, not an AI-assisted diagnostic tool that would typically involve MRMC studies to evaluate reader performance.

6. Standalone Performance (Algorithm Only)

Critique: The document describes the ExcelsiusHub™ as a "navigation system that includes hardware and software that enables real time surgical visualization... and a camera tracking system." Its function is to display the relative position of a tracked instrument on patient images to "help guide the surgeon's planning and approach."

While the software performs "all navigation functions, data storage, network connectivity, user management, case management, and safety functions," the primary performance is as a real-time guidance system with surgeon interaction. A "standalone" performance in the sense of an algorithm making a decision without human-in-the-loop is not the design or intent of this type of device. Its "performance" is inherently linked to its ability to accurately track and display information for the human surgeon, and the testing described ("surgical simulations on phantom models") implicitly involves this human-in-the-loop context. No purely "algorithm only" performance metrics are provided.

7. Type of Ground Truth Used (for Test Set)

Critique: For the "surgical simulations conducted on phantom models," the type of ground truth would typically be:

Physical measurements: Highly accurate measurements of planned trajectories vs. actual instrument placement in the phantom using a precise measurement system (e.g., coordinate measuring machine, high-resolution CT scans after simulated instrument insertion).
Design specifications: The known geometric properties and landmarks of the phantom model.

However, the specific methodology for establishing this ground truth (e.g., who performed the measurements, the precision of the measurement tools) is not detailed in the provided text.

8. Sample Size for the Training Set

Critique: The document describes "Software validation and verification testing" but does not mention a "training set" in the context of machine learning or AI models. The device is a navigation system, not explicitly an AI-driven diagnostic or predictive model where a distinct training set for an algorithm would be common. The software lifecycle processes (IEC 62304) and usability engineering (IEC 62366) indicate standard software development and testing, not necessarily an AI training paradigm.

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

Critique: As no "training set" is mentioned or implied by the device's description as a navigation system, this question is not applicable based on the provided information.

Summary

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

August 25, 2021

Image /page/0/Picture/1 description: The image shows 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 a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K211616

Trade/Device Name: ExcelsiusHub Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 25, 2021 Received: May 26, 2021

Dear Kelly 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K211616

Device Name ExcelsiusHub™

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."

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

510(k) Summary: ExcelsiusHub™ System

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Primary Contact:	Kelly Baker, Ph.D.Senior Vice President, Regulatory and Clinical Affairs
Date Prepared:	August 23, 2021
Device Name:	ExcelsiusHub™
Common Name:	Computer-assisted surgical device
Classification:	Per 21 CFR as follows:§882.4560 Stereotaxic instrumentProduct Code(s): OLORegulatory Class: II
Primary Predicate:	ExcelsiusGPS® (K171651)
Other Predicates:	ExcelsiusGPS® Spine 1.1 Interbody Module (K191100)

Spine 1.1 Interbody N Excelsius3D™ Imaging System (K210912)

Purpose:

The purpose of this submission is to request clearance for the ExcelsiusHub™

Device Description:

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

ExcelsiusHub™ may be used in conjunction with ExcelsiusGPS® for guidance of navigated instruments along a planned trajectory using a robotic arm. When connected to ExcelsiusGPS®, ExcelsiusHub™ software is responsible for both navigation and guidance.

Indications for Use:

Technological Characteristics:

The ExcelsiusHub™ has similar technological characteristics to the predicate devices including the main system components, workflow, user interface, software features, and design. ExcelsiusHub™ is comparable to the predicates in terms of intended use, fundamental scientific technology, technological characteristics and principle of operation.

Device	SubjectExcelsiusHub™	PredicateExcelsiusGPS®(K171651, K191100)
Principle ofoperation	- Intraoperative/ preoperative images- Patient registration- Surgical planning (optional)- Real-time tracking of navigatedinstruments- Manual, free hand guidance ofinstruments	- Intraoperative/ preoperative images- Patient registration- Surgical planning (optional)- Real-time tracking of navigatedinstruments- Manual, free hand guidance ofinstruments- Guidance of instruments
Input images	3D preoperative exam3D intraoperative exam2D intraoperative examExcelsius3D™ CTExcelsius3D™ fluoroscopy	3D preoperative exam3D intraoperative exam2D intraoperative exam
Integratedplanningsoftware	ExcelsiusGPS® Planning andNavigation Application Software	ExcelsiusGPS® Planning andNavigation Application Software
Save/loadplanning	Yes	Yes
Merge imagesfunctionality	Yes	Yes
Image-guided	Yes	Yes
Patientregistrationmethod	Intra-Op CT: Registration FixturePre-Op CT: Fluoroscopic to Pre-OpCT MergeFluoroscopy: Registration FixtureExcelsius3D™ CTExcelsius3D™ fluoroscopy	Intra-Op CT: Registration FixturePre-Op CT: Fluoroscopic to Pre-OpCT MergeFluoroscopy: Registration Fixture

Comparison of Principles of Operation and Technological Characteristics

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

Device	SubjectExcelsiusHub™	PredicateExcelsiusGPS®(K171651, K191100)
Accuracyverification	Yes	Yes
Real timedisplay ofinstrumentposition	Yes	Yes
Patientfixation	Reference is fixed to patient's bonystructure such as a long bone, iliaccrest, spinous process, vertebra, etc.for tracking system	Reference is fixed to patient's bonystructure such as a long bone, iliaccrest, spinous process, vertebra, etc.for tracking system

*Excelsius3D 510(k) under FDA review (remove *s and this note upon clearance)

Performance Testing:

Verification and validation testing were conducted on ExcelsiusHub™ 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 ●
Qualitative validation to confirm intended use ●
Electrical Safety and Electromagnetic Compatibility .
- o Testing was performed to assure compliance with recognized safety standards for electrical safety and electromagnetic compatibility
  - IEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  - . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances
  - IEC 60601-1-6:2013 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usabilitv
  - IEC 62304:2015 Medical device software - Software lifecycle processes
  - IEC 62366:2015 Medical devices Part 1: Application of usability ■ engineering to medical devices

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.

Basis of Substantial Equivalence:

ExcelsiusHub™ has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use.

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

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).