ExcelsiusFlex™ when used in conjunction with ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of a tool holder to be used by surgeons for navigating and/or guiding compatible surgical instruments provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or directly acquired anatomical structures. The system is indicated to assist the surgeon in planning the position of the implant components and preparing the bony anatomy during orthopedic procedures.

The Total Knee Arthroplasty (TKA) implant systems compatible with ExcelsiusFlex™ are GENflex2® and ACTIFY™ Total Knee System.

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, fluoroscopy or directly acquired anatomical structures. The system is indicated for the planning of orthopedic devices and placement of spinal and orthopedic bone screws and interbody fusion devices.

Device Description

The ExcelsiusFlex™ is a robotic positioning system with a computer controlled robotic arm, hardware and software that works in conjunction with ExcelsiusHub™ , to enable real time surgical navigation and robotic guidance using patient tracking arrays and a positioning camera. The system assists the surgeon in implant placement planning and intraoperative tracking of patient anatomy by locating anatomical structures and stereotaxic positioning of surgical instruments relative to patient CT images or directly acquired anatomical structures. The navigation and quidance 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), or directly acquired anatomical structures. Once this reqistration is created, the software positions the robotic arm on a planned resection plane.

The ExcelsiusFlex™ is intended for stereotaxic surqery in surgical knee procedures to assist the surgeon in spatial positioning and orientation of a sagittal sawblade, planning the position of the femoral and tibial implants, and for bone preparation during total knee arthroplasty (TKA) procedures. The system constrains the position of the robotic arm to planned resection planes based on the pre-operative or intra-operative plans developed using ExcelsiusFlex™-TKA software on either the ExcelsiusHub™ or a planning laptop.

ExcelsiusFlex™ instruments consist of patient tracking instruments, patient attachment instruments, navigation instruments, end effectors and end effector instruments. Patient attachment instruments provides a point of rigid fixation for the patient tracking instruments. Patient tracking instruments and navigated instruments incorporate unique array patterns with reflective markers, and are used to track patient anatomy and surgical instruments. End effectors attach to the distal end of the robotic arm and provide a rigid connection to the saw blade.

AI/ML Overview

The provided text discusses the ExcelsiusFlex™ medical device and its clearance by the FDA. However, it does not contain specific acceptance criteria or details of a study that directly proves the device meets those criteria, such as a clinical performance study with specific quantitative metrics.

Instead, the document focuses on:

Regulatory Clearance (510(k) Summary): It states that the device is "substantially equivalent" to predicate devices based on technological characteristics, performance, and intended use.
Verification and Validation Testing: It lists the types of testing performed (non-clinical, surgical simulations, cadaveric quantitative/qualitative validation, electrical safety, EMC, software V&V) but does not provide the results or specific acceptance criteria met by these tests.
Safety and Standards Compliance: It mentions compliance with various IEC standards related to electrical safety, EMC, usability, and software lifecycle.

Therefore, many of the requested details cannot be extracted directly from the provided text. Based on the information available, here's what can be provided:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or corresponding reported device performance metrics in a readily extractable table format for clinical efficacy. The discussion of "substantial equivalence" implies that performance is comparable to predicate devices but no specific quantitative thresholds are provided.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion	Reported Device Performance (Quantified)	Comments / Source of Information
Clinical Efficacy(e.g., accuracy of navigation, precision of bone resection, success rate)(Criterion not explicitly stated)	Not explicitly provided in quantitative terms.	The device is deemed "substantially equivalent" to predicates, implying similar performance. The document only lists types of V&V testing, not results with acceptance thresholds.
Electrical Safety	Compliance with IEC 60601-1:2020	Stated as "Testing was performed to assure compliance."
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2014	Stated as "Testing was performed to assure compliance."
Usability	Compliance with IEC 60601-1-6:2020 and IEC 62366:2020	Stated as "Testing was performed to assure compliance."
Software Quality	Compliance with IEC 62304:2015 and FDA Guidance for Software	Stated as "Software validation and verification testing was performed in accordance with..."
Design Inputs / User Needs	Not explicitly quantified.	"Non-clinical system, software, and instrument verification and validation - demonstrated compliance with user needs and corresponding design inputs." No specific metrics provided.

Study Details (Based on provided text)

Since no full clinical study details with quantitative results are provided, many of these sections will indicate "Not provided in the text."

Sample size used for the test set and the data provenance:
- Test Set Sample Size: "Surgical simulations conducted on bone models" and "Cadaveric quantitative validation under clinically relevant scenarios" are mentioned. However, the specific number of bone models or cadavers used is not provided.
- Data Provenance: Not explicitly stated for the testing mentioned, but cadaveric studies typically involve human cadaveric specimens. The origin (e.g., country) is not provided. The mention of "pre-operative images" and "pre-op CT-based patient registration" for the device's operation implies that patient data is processed, but details for actual test sets are scarce. It's unclear if the testing was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not provided.
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:
- The document describes a robotic positioning system and navigation aid, not an AI interpretation device for human "readers." Therefore, a traditional MRMC study comparing human readers with and without AI assistance is not applicable to this device in the context of the provided text. The device "assists the surgeon" but the nature of this assistance isn't described as AI-based interpretation for a human reader.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device is a "robotic positioning system" and "surgical navigation and robotic guidance" system. It is explicitly stated as "intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of a tool holder to be used by surgeons," and "to assist the surgeon." This strongly implies a human-in-the-loop system. While components might operate autonomously (e.g., the robotic arm positioning itself), the overall performance as described is not a standalone, algorithm-only performance without human-in-the-loop.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For "surgical simulations conducted on bone models" and "cadaveric quantitative validation," the ground truth would likely be established through highly precise measurement devices (e.g., metrology, optical trackers, CMMs) or anatomical landmarks verified by anatomical experts. However, the specific type of ground truth (e.g., expert consensus for image segmentation, direct physical measurement, etc.) is not explicitly detailed for each test.
The sample size for the training set:
- The document describes verification and validation testing for performance and regulatory clearance. It does not explicitly mention a "training set" in the context of machine learning or AI model development testing. Therefore, relevant sample size for a training set is not provided.
How the ground truth for the training set was established:
- As no "training set" for an AI model is explicitly mentioned, the method for establishing its ground truth is not provided.

Summary

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June 14, 2024

Image /page/0/Picture/1 description: The image shows the logo for 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Globus Medical, Inc Jennifer Antonacci Senior Group Manager, Regulatory Affairs Valley Forge Business Center 2560 General Armistead Ave Audubon, Pennsylvania 19403

Re: K240721

Trade/Device Name: ExcelsiusFlex™ Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 15, 2024 Received: March 18, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

Sincerelv.

Jesse Muir -S Muir-S
Digitally signed by Jesse
Date: 2024.06.14 13:24:52
-04'00'

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

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Indications for Use

510(k) Number (if known) K240721

Device Name ExcelsiusFlex™

Indications for Use (Describe)

The Total Knee Arthroplasty (TKA) implant systems compatible with ExcelsiusFlex™ are GENflex2® and ACTIFY™ Total Knee System.

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: ExcelsiusFlex™

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Primary Contact:	Jennifer Antonacci, Ph.D.Senior Group Manager, Regulatory Affairs
Secondary Contact:	Suganya GopalakrishnanRegulatory Specialist
Date Prepared:	June 12, 2024
Device Name:	ExcelsiusFlex™
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:	Mako Total Knee Application (K193515)VELYS™ Robotic-Assisted Solution (K202769)ExcelsiusHub™ (K211616)

AQrate™(K182000)

Purpose:

The purpose of this submission is to request clearance for the ExcelsiusFlex™ and navigated instruments for bone preparation for primary total knee arthroplasty, and expanded indications for use for ExcelsiusHub.

Device Description:

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points on the patient's anatomy), or directly acquired anatomical structures. Once this reqistration is created, the software positions the robotic arm on a planned resection plane.

Indications for Use:

ExcelsiusFlex™ when used in conjunction with ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of a tool holder to be used by surgeons for navigating and/or quiding compatible surqical instruments provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or directly acquired anatomical structures. The system is indicated to assist the surgeon in planning the position of the implant components and preparing the bony anatomy during orthopedic procedures.

The Total Knee Arthroplasty (TKA) implant systems compatible with ExcelsiusFlex™ are GENflex2® and ACTIFY™ Total Knee System.

The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surqeons 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, fluoroscopy or directly acquired anatomical structures. The system is indicated for the planning of orthopedic devices and placement of spinal and orthopedic bone screws and interbody fusion devices.

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Technological Characteristics:

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

Device	SubjectExcelsiusFlex™	PredicateMako Total KneeApplication (K193515)	PredicateVELYS Robotic-Assisted Solution(K202769)
Principle ofoperation	- Preoperative images- Imageless registrationor pre-op CT-basedpatient registration- Surgical planning- Real-time tracking ofnavigated instruments- Active robot tracking	- Preoperative images- Pre-op CT-basedpatient registration- Surgical planning- Real-time tracking ofnavigated instruments- Active robot tracking	- Imageless patientregistration- Surgical planning- Real-time tracking ofnavigated instruments- Active robot tracking
SystemComponents	Base station, roboticarm, camera, displaymonitor, foot pedal,cutting system,preoperative planninglaptop	Guidance Module,robotic arm, camerastand, cutting system,preoperative planninglaptop	Base station: camera,power supply, RobotControl Unit, displaymonitor, foot pedal
Inputimages	3D pre-operative examNone (Imagelessregistration)	3D preoperative exam	None (Imagelessregistration)
Integratedplanningsoftware	Yes, Excelsius™-TKAsoftware	Yes	Yes

Comparison of Principles of Operation and Technological Characteristics

Performance Testing:

Verification and validation testing were conducted on ExcelsiusFlex™ alone and combined with ExcelsiusHub™ to confirm that the devices meet performance requirements under the indications for use and to ensure safety and efficacy of the svstem:

Non-clinical system, software, and instrument verification and validation -. demonstrated compliance with user needs and corresponding design inputs
Surgical simulations conducted on bone models .
Cadaveric quantitative validation under clinically relevant scenarios .
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 60601-1:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance

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. IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances
. IEC 60601-1-6:2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
. IEC 62304:2015 Medical device software - Software lifecycle processes
. IEC 62366:2020 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 (June 14, 2023) and IEC 62304:2006-05 Medical Device Software - Software life cycle processes. The Documentation Level for the software in this device is determined to be "Enhanced Documentation Level".

Basis of Substantial Equivalence:

ExcelsiusFlex™ 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).