Excelsius3D™ is a mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography, and 3D imaging of adult and pediatric patients. The system is indicated for use where a physician benefits from 2D and 3D information on anatomic structures and high contrast objects with high x-ray attenuation such as bony anatomy and metallic objects. Excelsius3D™ images are compatible with image guided systems such as ExcelsiusGPS®.

Device Description

Excelsius3D™ is a mobile X-ray imaging system that combines 2D fluoroscopy, 2D digital radiography, and 3D imaging into one unit for acquisition and visualization of 2D or 3D images of patient anatomy. Excelsius3D™ provides real-time image capture, post-capture processing and visualization, and DICOM storage of images.

AI/ML Overview

The provided text describes the Excelsius3D™ device and mentions various performance tests conducted. However, it does not detail specific acceptance criteria, reported device performance metrics against those criteria, or the methodology of a study proving the device meets acceptance criteria concerning AI assistance or standalone algorithm performance.

The document focuses on regulatory clearance based on substantial equivalence to predicate devices, referencing general performance testing categories like "Image quality assessment comparison and paired image analysis to predicates" and "Human cadaveric qualitative validation under clinically relevant scenarios." It also lists compliance with various IEC standards.

Therefore, based only on the provided text, I cannot complete the requested tables and descriptions related to specific acceptance criteria, device performance metrics, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details, or ground truth establishment for AI/algorithm performance).

The request seems to be looking for details typically found in a clinical study report or a more detailed performance evaluation section of a 510(k) submission, which are not present in this summary letter.

To answer your request, if this were a hypothetical scenario where the document did contain such information, the structure would be as follows:

Assuming hypothetical data that would be present in a more detailed submission for this kind of device:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter/Metric	Acceptance Criterion	Reported Device Performance
Image Quality (e.g., Spatial Resolution)	Quantitative threshold (e.g., >= X lp/mm)	Achieved Y lp/mm (within or exceeding criterion)
Image Noise	Quantitative threshold (e.g., <= Z HU standard deviation in uniform phantom)	Achieved W HU standard deviation (within or exceeding criterion)
Contrast Detectability	Ability to visualize specified low-contrast objects in phantom (e.g., 3mm 0.5% contrast at 100mGy)	Successfully detected specified objects (e.g., Detected 3mm 0.5% contrast objects)
3D Reconstruction Accuracy	Deviation from ground truth (e.g., <= V mm average error for fiducial markers)	Achieved U mm average error (within criterion)
Geometric Accuracy	Distortion measurement (e.g., <= T % distortion)	Achieved S % distortion (within criterion)
Workflow Efficiency / Image Acquisition Time	Time to acquire and reconstruct a 3D volume (e.g., <= R seconds)	Achieved Q seconds (met criterion)
Image Compatibility with Navigation Systems	Successful transfer and registration with specified navigation systems	Demonstrated successful data transfer and registration
Qualitative Image Assessment by Experts	Percentage of images rated "diagnostic" or "acceptable" by expert readers (e.g., >= P%)	Achieved O% (met criterion)

(Note: These are examples of common imaging system performance metrics. The actual metrics would be specific to Excelsius3D's intended use and technological features.)

2. Sample Size and Data Provenance

Test Set Sample Size: [Number of images or cases, e.g., "100 unique phantom scans and 20 cadaveric scans"]
Data Provenance: [e.g., "Prospective phantom studies and retrospective human cadaveric data acquired at a US-based university medical center."]

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: [e.g., "3 independent radiologists and 2 orthopedic surgeons."]
Qualifications of Experts: [e.g., "Each radiologist had >10 years of experience in diagnostic imaging, with sub-specialty training in musculoskeletal imaging. Each orthopedic surgeon had >15 years of experience in spinal surgery, routinely using intraoperative imaging."]

4. Adjudication Method for Test Set

Adjudication Method: [e.g., "Majority vote (2+1) among the three radiologists for image quality assessment. Any discrepancy was resolved by consensus discussion with all three radiologists present. For cadaveric studies, anatomical ground truth was established by direct measurement during dissection or by a consulting anatomist."]

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

Was an MRMC study done? [Based on the provided text, a formal MRMC comparative effectiveness study demonstrating human reader improvement with AI assistance is not indicated. The document focuses on the device's technical performance and substantial equivalence to predicates.]
If yes, effect size of human reader improvement: [If such a study were done, it would quantify the improvement in diagnostic accuracy, confidence, or efficiency when readers use the AI-assisted system versus conventional methods. e.g., "An MRMC study showed a 15% increase in sensitivity for detecting subtle fractures when radiologists used the AI system, while maintaining specificity."]

6. Standalone (Algorithm Only) Performance

Was standalone performance done? [The provided text does not describe an AI/algorithm component requiring standalone performance evaluation. The device is an image acquisition system. If it had integrated AI for automated detection or measurement, then yes, standalone performance would be applicable.]
If yes, details: [e.g., "Standalone performance of the automated fracture detection algorithm achieved an F1-score of 0.92 on the test set."]

7. Type of Ground Truth Used

Type of Ground Truth: [e.g., "For phantom studies, the ground truth was known physical properties and configurations of the phantom. For cadaveric studies, ground truth for anatomical structures and implanted devices was established through direct observation during dissection, and confirmed by an expert anatomist's review of pre- and post-dissection imaging (e.g., high-resolution CT/MRI) and photographic documentation."]

8. Training Set Sample Size

Sample Size for Training Set: [Not applicable for a purely physical imaging system without a machine learning component requiring a training set. If there were ML components, then "Not explicitly stated in the provided document, but typically thousands to tens of thousands of images would be used for training deep learning models."]

9. How Ground Truth for Training Set Was Established

How Ground Truth Was Established (Training Set): [Not applicable for a purely physical imaging system. If there were ML components, then "Not explicitly stated in the provided document, but typically through expert annotation (e.g., radiologists, surgeons) following a pre-defined labeling protocol."]

Summary

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August 12, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo 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, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. AUDUBON PA 19403

Re: K210912

Trade/Device Name: Excelsius3D™ Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: July 20, 2021 Received: July 21, 2021

Dear Dr. 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 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 (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 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,

. for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K210912

Device Name Excelsius3D™

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: Excelsius3D™

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Contact:	Kelly Baker, Ph.D.Senior Vice President, Regulatory and Clinical Affairs
Date Prepared:	July 20, 2021
Device Name:	Excelsius3D™
Common Name:	Computer-assisted mobile image-intensified fluoroscopic andX-ray system
Classification:	Per 21 CFR as follows:§892.1650 Image-intensified Fluoroscopic X-ray System,MobileProduct Code(s): OWB, OXO, JAARegulatory Class: II

Primary Predicate: Medtronic O-Arm Imaging System (K092564) Other Predicates: Medtronic O-Arm O2 Imaging System (K200074) Reference Device: GE Optima XR220amx/XR200amx (K142383)

Purpose:

The purpose of this submission is to request clearance of the Excelsius3D™

Device Description:

Visualization of patient anatomy assists in localizing regions of pathology for preoperative examination, in vivo surgical procedures, and post-surgical analysis. The three imaging modalities can assist physicians with performing complex surqical procedures, such as spinal deformity correction or deep brain stimulation (DBS) placement.

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Indications for Use:

Technological Characteristics:

The Excelsius3D™ has similar technological characteristics to the predicate devices including the main system components, workflow, user interface, software features, and design. The Excelsius3D™ is comparable to the predicates in terms of intended use, fundamental scientific technology, technological characteristics and principle of operation.

	SubjectExcelsius3D™	PredicateO-Arm(K092564, K200074)	ReferenceOptima XR220amx(K142383)
IntendedApplications	Orthopaedic, cranial	Orthopaedic, cranial	Orthopaedic, cranial(& gastrointestinal,thoracic, pulmonary)
ImagingModalities	2D fluoroscopy3D imaging2D digital radiography	2D fluoroscopy3D imaging	2D digital radiography
GantryMotion	Isocentric	Isocentric	N/A
GantryRotation	360°	360°	N/A
Gantry StoredPositions	Yes	Yes	N/A
X-ray TubeType	Rotating anode	Rotating anode	Rotating anode
X-ray Beam/CollimationType	Cone beam with x-yshutters	Cone beam with x-yshutters	Cone beam with x-yshutters
ImageAcquisitionPresets	Yes	Yes	Yes
Method ofImageAcquisition	Hand switchor foot pedal	Hand switchor foot pedal	Hand switch
ImageTransfer	Yes	Yes	Yes
Cybersecurity	Industry standardprotocols	Industry standardprotocols	Industry standardprotocols

Comparison of Principles of Operation and Technological Characteristics

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Performance Testing:

Verification and validation testinq were conducted on Excelsius3D™ to confirm that the device meets performance requirements under the indications for use and to ensure the system performs as intended.

Non-clinical system and software verification and validation. ●
- Software validation and verification testing was performed in accordance o 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.
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 60601-1-3:2013 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
  - l IEC 60601-1-6:2013 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
  - .. IEC 60601-2-43:2010 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of Xray equipment for interventional procedures
  - IEC 60601-2-54:2015 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
  - I IEC 60825-1:2007 Safety of laser products - Part 1: Equipment classification, and requirements
  - . IEC 62304:2015 Medical device software - Software lifecycle processes
  - . IEC 62366:2015 Medical devices - Part 1: Application of usability engineering to medical devices
Image quality assessment comparison and paired image analysis to ● predicates
Human cadaveric qualitative validation under clinically relevant scenarios ●

Basis of Substantial Equivalence:

Excelsius3D™ has been found to be substantially equivalent to the predicate devices with respect to technological characteristics, imaging performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.