(72 days)
The EXCELSIUS GPS™ 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.
The EXCELSIUS GPS™ is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (preoperative CT, intraoperative CT and fluoroscopy), using a dynamic reference base and positioning camera. 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). Once this registration is created, the software displays the relative position of a tracked instrument, including the end effector of the robotic arm, on the patient images. This visualization can help guide the surgeon's planning and approach. As an aid to visualization, the surgeon can plan implant placement on the patient images prior to surgery. The information of the plan coupled with the registration provides the necessary information to provide visual assistance to the surgeon during free hand navigation or during automatic robotic alignment of the end effector. During surgery, the system tracks the position of GPS compatible instruments, including the end effector of the robotic arm, in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. Standard non-navigated metallic instruments that fit through the quide tube at the selected trajectory may be used without navigation while the quide tube is stationary, for uses such as bone preparation (e.g. rongeurs, reamers etc.) or placing implants (e.g. rod inserters, locking cap drivers) that are not related to screw placement. Navigation can also be performed without guidance. System software is responsible for all motion control functions, navigation functions, data storage, network connectivity, user management, case management, and safety functions. EXCELSIUS GPSTM surgical instruments are non-sterile, re-usable instruments that can be operated manually or with the use of the positioning system. EXCELSIUS GPS™ instruments consist of registration instruments, patient reference instruments, surgical instruments, and end effectors. Registration instruments incorporate arrays of reflective markers, and are used to track patient anatomy and surgical instruments and implants; components include the verification probe, surveillance marker, surgical instrument arrays, intra-op CT reqistration fixture, fluoroscopy registration fixture, and dynamic reference base (DRB). Patient reference instruments are either clamped or driven into any appropriate rigid anatomy that is considered safe and provides a point of rigid fixation for the DRB. Surqical instruments are used to prepare the implant site or implant the device, and include awls, drills, drivers, taps, and probes, End effectors are wirelessly powered quide tubes that attach to the distal end of the robotic arm and provide a rigid structure for insertion of surgical instruments.
The provided document is a 510(k) summary for the EXCELSIUS GPS™ robotic positioning system. It describes the device, its intended use, and a comparison to predicate devices, along with various performance testing categories. However, it does not contain acceptance criteria or detailed results from a specific study proving the device directly meets acceptance criteria for accuracy or clinical outcomes.
Instead, the document broadly describes categories of performance testing that were conducted to ensure safety and efficacy, and confirms compliance with recognized standards.
Therefore, many of the requested details about specific acceptance criteria and a study proving them cannot be extracted from this document. I will provide what can be gleamed and note where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric Category | Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Summary from document) |
|---|---|---|
| System, Software, and Instrument Performance | (Not explicitly stated) | Verification and validation testing conducted to confirm device meets performance requirements under indications for use and to ensure safety and efficacy. |
| Surgical Simulations on Phantom Models | (Not explicitly stated) | Conducted. (No specific numerical results or success rates provided) |
| Human Cadaveric Quantitative Validation | (Not explicitly stated) | Conducted under clinically relevant scenarios. (No specific numerical results or success rates provided). This likely assessed accuracy or placement deviation. |
| Electrical Safety | Compliance with IEC 60601-1:2012 | Testing performed to assure compliance. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2:2014 | Testing performed to assure compliance. |
| Biocompatibility | Compliance with ISO 10993 standards and FDA Guidance | Evaluation confirms EXCELSIUS GPS meets biocompatibility requirements. |
| Software Verification & Validation | Compliance with FDA Guidance (2005) & IEC 62304:2006-05 (MAJOR level of concern) | Performed in accordance with these standards. |
Missing Information: The document states that "Verification and validation testing was conducted... to confirm that the device meets performance requirements," but it does not explicitly list what those performance requirements (acceptance criteria) were in terms of specific quantitative metrics (e.g., accuracy in mm, successful screw placement rate).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The document mentions "Surgical simulations conducted on phantom models" and "Human cadaveric quantitative validation under clinically relevant scenarios" but does not give the number of cases, studies, or specific phantom/cadaver units used.
- Data Provenance: Not specified. It's likely these tests were conducted internally by Globus Medical or a contracted research organization, but no country of origin or whether it was retrospective/prospective is mentioned. Given the nature of cadaveric and phantom studies, they are typically prospective experimental designs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Not specified. The document does not describe a method for establishing or adjudicating ground truth in a clinical or expert review context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on how human readers improve with AI vs. without AI assistance is not described in this document. The EXCELSIUS GPS is a robotic positioning system for surgical guidance, not an AI-assisted diagnostic imaging device for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, the performance testing described (e.g., "Non-clinical system, software, and instrument verification and validation," "Surgical simulations conducted on phantom models," "Human cadaveric quantitative validation") generally represents standalone performance of the device's accuracy and functionality. The system "determines the registration or mapping," "displays the relative position of a tracked instrument," and "provides visual assistance to the surgeon," implying the device's inherent capability to perform these functions. Specific metrics for this standalone performance (e.g., tracking accuracy, registration accuracy) are not detailed.
7. The Type of Ground Truth Used
- For the performance testing mentioned:
- For "Surgical simulations on phantom models" and "Human cadaveric quantitative validation," the ground truth would likely be established by direct measurement using precision instruments (e.g., coordinate measuring machines, highly accurate imaging) to compare the device's reported position/trajectory against the actual physical position/trajectory.
- For compliance assessments (electrical safety, EMC, biocompatibility, software V&V), the "ground truth" is adherence to the specified international standards and FDA guidance.
8. The Sample Size for the Training Set
- Not applicable/Not specified. This document describes a surgical guidance system, not a machine learning model that would typically have a distinct "training set" in the common sense of AI/ML algorithm development. While software development (which is discussed) involves testing, there's no mention of a traditional machine learning training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified (refer to point 8).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 16, 2017
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Globus Medical Inc. Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403
Re: K171651
Trade/Device Name: EXCELSIUS GPS Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 31, 2017 Received: August 1, 2017
Dear Dr. Kelly J. 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. 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 (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
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)
Device Name EXCELSIUS GPSTM
Indications for Use (Describe)
The EXCELSIUS GPS™ 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.
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary: EXCELSIUS GPS™
- Company: Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 610-930-1800
- Contact: Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
- June 1, 2017 Date Prepared:
- EXCELSIUS GPS™ Device Name:
- Common Name: Computer-assisted surgical device
- Per 21 CFR as follows: Classification: §882.4560 Stereotaxic instrument Product Code(s): OLO Regulatory Class: II
- EXCELSIUS GPS™ Predicates: Primary predicate: StealthStation (K133444) Additional predicate: ROSA Spine (K151511)
EXCELSIUS GPS™ Instruments Additional predicates: CREO® (K143633) REVERE® (K133350) REVOLVE® (K111449) QUARTEX™ (K161591) ELLIPSE® (K123783) SI-LOK® (K112028) CAPTIVATE™ (K162825)
Purpose:
The purpose of this submission is to request clearance of EXCELSIUS GPS™ and EXCELSIUS GPSTM Instruments.
Device Description:
The EXCELSIUS GPS™ is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (preoperative CT, intraoperative CT and fluoroscopy), using a dynamic reference base and positioning camera. 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
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anatomy). Once this registration is created, the software displays the relative position of a tracked instrument, including the end effector of the robotic arm, on the patient images. This visualization can help guide the surgeon's planning and approach. As an aid to visualization, the surgeon can plan implant placement on the patient images prior to surgery. The information of the plan coupled with the registration provides the necessary information to provide visual assistance to the surgeon during free hand navigation or during automatic robotic alignment of the end effector. During surgery, the system tracks the position of GPS compatible instruments, including the end effector of the robotic arm, in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. Standard non-navigated metallic instruments that fit through the quide tube at the selected trajectory may be used without navigation while the quide tube is stationary, for uses such as bone preparation (e.g. rongeurs, reamers etc.) or placing implants (e.g. rod inserters, locking cap drivers) that are not related to screw placement. Navigation can also be performed without guidance. System software is responsible for all motion control functions, navigation functions, data storage, network connectivity, user management, case management, and safety functions. EXCELSIUS GPSTM surgical instruments are non-sterile, re-usable instruments that can be operated manually or with the use of the positioning system.
EXCELSIUS GPS™ instruments consist of registration instruments, patient reference instruments, surgical instruments, and end effectors. Registration instruments incorporate arrays of reflective markers, and are used to track patient anatomy and surgical instruments and implants; components include the verification probe, surveillance marker, surgical instrument arrays, intra-op CT reqistration fixture, fluoroscopy registration fixture, and dynamic reference base (DRB). Patient reference instruments are either clamped or driven into any appropriate rigid anatomy that is considered safe and provides a point of rigid fixation for the DRB. Surqical instruments are used to prepare the implant site or implant the device, and include awls, drills, drivers, taps, and probes, End effectors are wirelessly powered quide tubes that attach to the distal end of the robotic arm and provide a rigid structure for insertion of surgical instruments.
Indications for Use:
The EXCELSIUS GPS™ is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or quide 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.
Technological Characteristics:
The EXCELSIUS GPS™ and EXCELSIUS GPS™ Instruments have similar technological characteristics to the predicate devices including the main system
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components, workflow, user interface, software features, and design. The EXCELSIUS GPS™ System is comparable to the predicates in terms of intended use, fundamental scientific technology, technological characteristics and principle of operation. The table below provides a comparison of technological characteristics and principles of operation for the subject EXCELSIUS GPS™ and the predicate devices.
| Device | SubjectEXCELSIUS™ GPS | PredicateStealthStation(K133444) | PredicateROSA Spine(K151511) |
|---|---|---|---|
| Principle ofoperation | - Intraoperative/preoperative images- Patient registration- Surgical planning- Real-time tracking ofnavigated instruments- Guidance of instruments | - Intraoperative/preoperative images- Patient registration- Surgical planning- Real-time tracking ofnavigated instruments | - Intraoperative images- Patient registration- Surgical planning- Guidance of instruments |
| Input images | 3D pre-operative exam3D intra-operative exam2D intra-operative exam | 3D pre-operative exam3D intra-operative exam2D intra-operative exam | 3D intra-operative exam |
| Integratedplanningsoftware | EXCELSIUS™ GPSPlanning and NavigationApplication software | Synergy Spine software | Rosanna Spine (Medtech) |
| Save/loadplanning | Yes | Yes | Yes |
| Merge imagesfunctionality | Yes | Yes | Yes |
| Trajectoryplanningparameters | Entry point, target point,instrument length/diameter | Entry point, target point,instrument length/diameter | Entry point, target point,instrument length/diameter |
| Localizationmeans | Optical system (infraredcamera) | Optical (infrared camera)or electromagnetic system | Robot arm absoluteencoders and opticalsystem (infrared camera) |
| Image-guided | Yes | Yes | Yes |
| Controller | Force-controlledmovement allowingrobotic arm positioning | No controller; instrumentsare manually positionedby the surgeon. | Axis controller per jointKinematic transformationSupervisor module |
| Patientregistrationmethod | Intra-op CT: RegistrationfixturePre-op CT: Fluoroscopicto pre-op CT mergeFluoroscopy: Registrationfixture | Point-to-point registrationwith anatomical markersIntra-op CT: Calibrated CTgantry to camera mergePre-op CT: Point mergeFluoroscopy: Registrationfixture | 3D registration with X-Raypattern containingradiopaquemarkers |
| Accuracyverification onanatomicallandmarks | Yes (probe) | Yes (probe) | Yes (probe) |
| Real timedisplay ofinstrumentposition | Yes | Yes | Yes |
| Device | SubjectEXCELSIUS™ GPS | PredicateStealthStation(K133444) | PredicateROSA Spine(K151511) |
| Provide guideforinstruments | Yes, instruments are usedthrough the guide tube onthe robotic arm or aremanually positioned by thesurgeon. | No, instruments aremanually positioned by thesurgeon. | Yes, instruments aremounted onto the roboticarm. |
| Patientfixation | Reference is fixed topatient's bony structuresuch as a long bone, iliaccrest, spinous process,vertebra, etc. for trackingsystem | Reference is fixed to thepatient's iliac crest orclamped on the spinousfor tracking system | Reference is fixed to thepatient's iliac crest fortracking system |
Comparison of Principles of Operation and Technological Characteristics
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Performance Testing:
Verification and validation testing was conducted on EXCELSIUS GPS™ 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
- Surgical simulations conducted on phantom models ●
- Human cadaveric quantitative validation under clinically relevant scenarios ●
- Compliance conformity assessments per: ●
- o IEC 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2, General o
Requirements for Basic Safety and Essential Performance -Collateral Standard Electromagnetic Compatibility, 2007
- o IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General
- o Requirements for Basic Safety and Essential Performance Usability
Biocompatibility:
The biocompatibility evaluation for EXCELSIUS GPS™ has been conducted in accordance with ISO 10993 standards and blue book memorandum #G95-1 entitled "Use of International Standard ISO-10993, Biological Evaluation of Medical DevicesPart-1: Evaluation and Testing", May 1, 1995 and FDA Guidance "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," June 16, 2016. The evaluation confirms that EXCELSIUS GPS meets biocompatibility requirements.
Electrical Safety and Electromagnetic Compatibility:
Testing was performed to assure compliance with recognized safety standards: IEC 60601-1:2012 standard for electrical safety and IEC 60601-1-2:2014 standard for electromagnetic compatibility.
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
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in Medical Devices (May 11, 2005) and IEC 62304:2006-05 Medical Device Software - Software life cycle processes. The software for this device is considered a "MAJOR" level of concern.
Basis of Substantial Equivalence:
EXCELSIUS GPS™ 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.
§ 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).