Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:

Proton density (PD) (also called hydrogen density)
Spin-lattice relaxation time (T1)
Spin-spin relaxation time (T2)
Flow dynamics
Chemical Shift

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

Device Description

The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K143008. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study details:

Overall Assessment: The provided document is a 510(k) summary for a software modification to an existing MRI system (Vantage Titan 3T, MRT-3010/A5, V2.50). It focuses primarily on demonstrating substantial equivalence to the previously cleared version, with the addition of "mART" and "mART+" functionalities (Metal Artifact Reduction Technique and mART with View Angle Tilting).

Crucially, this document does not contain explicit, quantitative acceptance criteria for device performance in the context of metal artifact reduction, nor does it detail a clinical study with a specified sample size, expert readers, or ground truth establishment in the manner typically expected for a new diagnostic claim. Instead, it relies on demonstrating that the new functionalities do not alter the existing indications for use and that they are safe and effective through bench and volunteer imaging.

Below is a breakdown based on your requested information, highlighting what is and is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit quantitative acceptance criteria with corresponding reported performance values are not provided in this 510(k) summary. The document states: "Bench testing utilizing both phantom and representative clinical images were obtained to demonstrate the subject device is capable of reducing metal related artifacts on MR images." This is a qualitative statement of capability rather than a measurable acceptance criterion.

Acceptance Criterion	Reported Device Performance
Not specified in this document.	The device is capable of reducing metal related artifacts on MR images.
(e.g., Minimum percentage reduction in artifact volume, specific signal-to-noise ratio improvement, visual assessment score improvement)	(e.g., 50% reduction in specific artifact types, X dB SNR improvement in regions near metal, improved visual clarity score by Y points based on expert review)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document mentions "phantom and representative clinical images" and "volunteer clinical imaging" but does not quantify the number of images or volunteers.
Data Provenance:
- Country of Origin: Not explicitly stated for the "representative clinical images" or "volunteer clinical imaging."
- Retrospective or Prospective: Not explicitly stated. "Volunteer clinical imaging" would imply prospective acquisition for the purpose of the test, but the "representative clinical images" source is unclear.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
Role of Experts: If experts were involved in assessing the "reduction of metal related artifacts," their role and qualifications are not detailed. The document only mentions that the images, "when interpreted by a trained physician," yield useful diagnostic information in general, not specifically for the evaluation of the mART features.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the lack of specified experts, a formal adjudication process is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described.
Effect Size of Human Reader Improvement: Therefore, no effect size is reported. This submission focuses on a new imaging sequence feature (mART/mART+) rather than an AI-assisted diagnostic tool designed to directly improve human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable in the typical sense of a standalone algorithm for diagnostic interpretation. The mART and mART+ functionalities are image acquisition and reconstruction techniques integrated into the MRI system. Their "performance" is assessed by the quality of the resulting image, which is then interpreted by a human. The bench and phantom testing could be considered a form of standalone technical evaluation of the image quality improvement.

7. The Type of Ground Truth Used

Ground Truth: For the "reduction of metal related artifacts," the implied ground truth seems to be visual qualitative assessment of image quality improvements in regions affected by metal. For phantom studies, the ground truth would be the known properties of the phantom and the presence/absence of metal. For "volunteer clinical imaging," a definitive "ground truth" to quantitatively measure artifact reduction is not explicitly described (e.g., an independent reference standard for quantifying artifact severity). The focus is on demonstrating the capability of the feature to reduce artifacts.

8. The Sample Size for the Training Set

This information is not provided. As these are image acquisition/reconstruction techniques rather than a machine learning model for diagnosis, a "training set" in the conventional AI sense may not be directly applicable or explicitly detailed in this type of submission. If any machine learning components are involved in the mART/mART+ algorithms, the details of their training are not disclosed here.

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

This information is not provided, as a training set and its ground truth establishment are not discussed in the context of this 510(k) submission.

Summary of Missing Information:

This 510(k) summary for a modified MRI device primarily relies on demonstrating that new image acquisition/reconstruction features (mART and mART+) do not alter the existing indications for use, maintain safety parameters, and are qualitatively effective at reducing metal artifacts through bench and volunteer imaging. It does not provide detailed information on quantitative acceptance criteria, large-scale clinical studies with specific sample sizes, expert ground truth establishment, or human-in-the-loop performance improvements, which are more common requirements for submissions involving new diagnostic AI algorithms.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

Canon Medical Systems Corporation % Mr. Orlando Tadeo Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780

June 26, 2019

Re: K191128

Trade/Device Name: Vantage Titan 3T, MRT-3010/A5, V2.50 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: April 26, 2019 Received: April 29, 2019

Dear Mr. Tadeo:

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 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

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K191128

Device Name Vantage Titan 3T, MRT-3010/A5, V2.50

Indications for Use (Describe)

·Proton density (PD) (also called hydrogen density)
·Spin-lattice relaxation time (T1)
·Spin-spin relaxation time (T2)
·Flow dynamics
·Chemical Shift

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

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."

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Image /page/3/Picture/0 description: The image contains the logo for Canon Medical Systems USA, Inc. The word "Canon" is written in red, with the rest of the text in black. The text is left-aligned and appears to be a company logo.

Made For life

K191128

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92

1. CLASSIFICATION and DEVICE NAME

Classification Name:	Magnetic Resonance Diagnostic Device
Regulation Number:	90-LNH (Per 21 CFR § 892.1000)
Trade Proprietary Name:	Vantage Titan 3T
Model Number:	MRT-3010/A5, V2.50

2. SUBMITTER'S NAME

Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

3. OFFICIAL CORRESPONDENT

Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance Canon Medical Systems Corporation

4. CONTACT PERSON, U.S. AGENT and ADDRESS

Contact Person

Janine F. Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7853 Fax: (714) 730-1310 E-mail: jfreyes@us.medical.canon

Official Correspondent/U.S. Agent

Paul Biggins Senior Director, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-7808 Fax: (714) 730-1310 E-mail: pbiggins@us.medical.canon

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EDICAL SYSTEMS USA, INC.

Made For life

1. MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
1. ESTABLISHMENT REGISTRATION 9614698
1. DATE PREPARED April 26, 2019
1. DEVICE NAME Vantage Titan 3T, MRT-3010/A5, V2.50
1. TRADE NAME

Vantage Titan 3T, MRT-3010/A5, V2.50

10. CLASSIFICATION NAME

Magnetic Resonance Diagnostic Device (MRDD)

11. CLASSIFICATION PANEL

Radiology

12. DEVICE CLASSIFICATION

Class II (per 21 CFR 892.1000, Magnetic Resonance Diagnostic Device)

13. PRODUCT CODE

90-LNH

14. PREDICATE DEVICE

Predicate Device (system): Vantage Titan 3T, MRT-3010/A5, V2.50

System	Subject	Predicate Device
	Vantage Titan 3T, MRT-3010/A5, V2.50	Vantage Titan 3T, MRT-3010/A5, V2.50
Marketed By	Canon Medical Systems USA, Inc.	Canon Medical Systems USA, Inc.
510(k) Number	This Submission	K143008
Clearance Date		April 9th, 2015

15. REASON FOR SUBMISSION

Modification of a cleared device

16. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

2441 Michelle Drive, Tustin, CA 92780 PHONE: 800-421-1968 https://us.medical.canon

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CAL SYSTEMS USA, INC.

Made For life

17. DEVICE DESCRIPTION

18. SUMMARY OF CHANGE(S)

This submission is to report the following software functionalities have been added:

mART: Metal Artifact Reduction Technique ●
mART+: Metal Artifact Reduction Technique with the addition of View Angle Tilting (VAT) ●

19. SAFETY PARAMETERS

Item	Subject Device:Vantage Titan 3T,MRT-3010/A5, V2.50	Predicate Device:Vantage Titan 3T,MRT-3010/A5, V2.50	Notes
Static field strength	3T	3T	Same
Operational Modes	Normal and 1st Operating Mode	Normal and 1st Operating Mode	Same
i. Safety parameter display	SAR, dB/dt	SAR, dB/dt	Same
ii. Operating mode accessrequirements	Allows screen access to 1st leveloperating mode	Allows screen access to 1st leveloperating mode	Same
Maximum SAR	4W/kg for whole body (1st operatingmode specified in IEC 60601-2-33:2010 +A1:2013)	4W/kg for whole body (1st operatingmode specified in IEC 60601-2-33:2010 +A1:2013)	Same
Maximum dB/dt	1st operating mode specified in IEC60601-2-33: 2010 +A1:2013	1st operating mode specified in IEC60601-2-33: 2010 +A1:2013	Same
Potential emergencycondition and meansprovided for shutdown	Shutdown by Emergency Ramp DownUnit for collision hazard forferromagnetic objects	Shutdown by Emergency RampDown Unit for collision hazard forferromagnetic objects	Same

20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K143008.

21. INDICATIONS FOR USE

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DICAL SYSTEMS USA, INC.

Made For life

Proton density (PD) (also called hydrogen density)
Spin-lattice relaxation time (T1)
Spin-spin relaxation time (T2)
Flow dynamics ●
Chemical Shift

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

22. SUMMARY OF DESIGN CONTROL ACTIVITIES

Design controls for the software functionalities were conducted under K143008. The functionalities in this submission are embedded in software version 2.5. There are no new design control activities to report as part of this device modification.

23. SAFETY

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards.

This device is based upon the same technologies, materials and software as the predicate device. Risk activities were conducted in concurrence with established medical device development standards and guidance. Additionally, testing was done in accordance with applicable recognized consensus standards published by the International Electrotechnical Commission (IEC) for medical devices and the National Electrical Manufacturers Association (NEMA):

LIST OF APPLICABLE STANDARDS

IEC60601-1 (2005), Amd.1 (2012) ●
IEC60601-1-2 (2007)
IEC60601-1-8 (2006), Amd.1 (2012)
IEC60601-2-33 (2010), Amd.1 (2013) ●
IEC60825-1 (2007) ●
IEC62304 (2006)
IEC62366 (2007), Amd.1 (2014)
NEMA MS 1 (2008) ●
NEMA MS 2 (2008)
NEMA MS 3 (2008)
NEMA MS 4 (2010) ●
NEMA MS 5 (2010)

24. TESTING

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, was included in K143008.

PHONE: 800-421-1968 2441 Michelle Drive, Tustin, CA 92780 https://us.medical.canon

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Image /page/7/Picture/3 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is written in red, with the rest of the text in black. The text is simple and clear, with a focus on the company name.

Made For life

Bench testing utilizing both phantom and representative clinical images were obtained to demonstrate the subject device is capable of reducing metal related artifacts on MR images.

25. SUBSTANTIAL EQUIVALENCE

Canon Medical Systems Corporation believes that the Vantage Titan 3T, MRT-3010/A5, V2.50 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate device, Vantage Titan 3T, MRT-3010/A5, V2.50, referenced in this submission. Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Titan 3T, MRT-3010/A5, V2.50 are substantially equivalent to the previously cleared predicate device.

26. CONCLUSION

The implementation of mART and mART+ on the Vantage Titan 3T, MRT-3010/A5, V2.5 software do not change the indications for use or the intended use of the device. Based upon bench testing, phantom imaging, volunteer clinical imaging, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.

Regulation Number and Section

N/A