Vantage Galan 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 Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K181593. 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.

AiCE is an optional noise reduction algorithm that improves image quality and reduces thermal noise by employing Deep Convolutional Neural Network methods.

AiCE is designed to remove Gaussian distributed noise in MR images for reducing contributions of thermal noise. In order to train a DCNN that can learn a model that represents thermal noise, the training datasets are created by adding Gaussian noise of different amplitudes to high-SNR images acquired with large number of averages.

The device is targeted for Brain and knee regions.

This software and its associated hardware are used on Canon MRI systems that are designed to communicate with the AiCE Reconstruction Processing Unit for MR.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Canon Medical Systems Corporation's Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Maintained or improved Low Contrast Detectability (LCD)	Performance (bench testing) using a Model Observer study determined that image Low Contrast Detectability was maintained or improved.
Statistical preference for AiCE images compared to other preferred filters	A Human Observer study demonstrated a statistical preference of AiCE when compared to other preferred filters.
Overall safety and effectiveness for intended use	Concluded that the subject device is safe and effective for its intended use based on bench testing, phantom imaging, volunteer clinical imaging, successful completion of software validation, and application of risk management and design controls.

Study Details

Sample size used for the test set and the data provenance:
- Human Observer Study: 160 images.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
- Model Observer Study: Not specified, but generally involves simulated data or specific phantom images.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Human Observer Study: 6 physicians.
- Qualifications: Not specified (e.g., years of experience, subspecialty).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly stated. The document mentions a "statistical preference," which implies a comparative assessment by the readers, but the method of resolving discrepancies or forming a consensus for ground truth is not detailed.
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:
- Yes, a Human Observer study was conducted with 6 physicians and 160 images.
- Effect Size: The document states that the study "demonstrated a statistical preference of AiCE when compared to other preferred filters." However, it does not quantify the effect size in terms of human reader improvement with AI vs. without AI assistance (e.g., AUC improvement, sensitivity/specificity increase). The study focused on preference rather than diagnostic accuracy improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a "Model Observer study" was conducted to determine if image Low Contrast Detectability was maintained or improved. This is a form of standalone evaluation focusing on image quality metrics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Human Observer Study: The "statistical preference" suggests that the physicians were evaluating image quality, and their collective preference served as a form of expert consensus on the perceived image quality rather than a ground truth for a specific pathology.
- Model Observer Study: Ground truth would typically be established based on known physical properties of the phantoms used or simulated data, where the true low-contrast objects are precisely defined.
The sample size for the training set:
- The document states: "In order to train a DCNN that can learn a model that represents thermal noise, the training datasets are created by adding Gaussian noise of different amplitudes to high-SNR images acquired with large number of averages."
- The specific number of images or cases in the training set is not provided.
How the ground truth for the training set was established:
- The training datasets were created by "adding Gaussian noise of different amplitudes to high-SNR images acquired with large number of averages."
- This implies that the "ground truth" for training the deep convolutional neural network (DCNN) was essentially the original high Signal-to-Noise Ratio (SNR) images before the artificial noise was added. The DCNN was trained to learn how to transform noisy images back to these high-SNR "ground truth" representations.

Summary

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March 9, 2020

Canon Medical Systems Corporation % Mr. Paul Biggins Senior Director, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive TUSTIN CA 92780

Re: K192574

Trade/Device Name: Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: March 4, 2020 Received: March 5, 2020

Dear Mr. Biggins:

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

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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 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)

K192574

Device Name

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

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)

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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
Classification	90-LNH
Regulation Number:	21 CFR § 892.1000
Trade Proprietary Name:	Vantage Galan 3T, MRT-3020, V6.0 withAiCE Reconstruction Processing Unit forMR
Model Number:	MRT-3020

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

Paul Biggins Senior Director Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7808 Fax: (714) 730-1310 E-mail: pbiggins@us.medical.canon

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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 pbiggins@us.medical.canon

5. MANUFACTURING SITE

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

6. ESTABLISHMENT REGISTRATION

9614698

7. DATE PREPARED

January 23, 2020

8. DEVICE NAME

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

9. TRADE NAME

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

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

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14. PREDICATE DEVICE

Predicate Device (system): Vantage Galan 3T, MRT-3020/A7, V5.0 (K181593)

System	Subject	Predicate Device
	Vantage Galan 3T,MRT-3020, V6.0 withAiCE ReconstructionProcessing Unit for MR	Vantage Galan 3T,MRT-3020/A7,V5.0
Marketed By	Canon Medical SystemsUSA	Canon Medical SystemsUSA
510(k)Number	This Submission	K181593
ClearanceDate		Aug 13, 2018

15. REASON FOR SUBMISSION

Modification of a cleared device

16. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

17. DEVICE DESCRIPTION

AiCE is an optional noise reduction algorithm that improves image quality and reduces thermal noise by employing Deep Convolutional Neural Network methods.

The device is targeted for Brain and knee regions.

This software and its associated hardware are used on Canon MRI systems that are designed to communicate with the AiCE Reconstruction Processing Unit for MR.

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18. SUMMARY OF CHANGE(S)

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

Summary of Hardware changes:

AiCE Reconstruction Processing Unit for MR

Summary of Software Changes:

•
AiCE is a newly-added optional noise reduction algorithm that improves image quality and reduces thermal noise by employing Deep Convolutional Neural Network methods.

The device is targeted for Brain and knee regions and is MR system independent meaning that this software and its associated hardware are used on Canon MRI systems that are designed to communicate with the AiCE Reconstruction Processing Unit for MR.

19. SAFETY PARAMETERS

Item	Subject Device:Vantage Galan 3T, MRT-3020,V6.0 with AiCE ReconstructionProcessing Unit for MR	Predicate Device:Vantage Galan 3.0T,MRT-3020/A7, V5.0	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 access requirements	Allows screen access to 1st level operating mode	Allows screen access to 1st level operating mode	Same
Maximum SAR	4W/kg for whole body (1st operating mode specified in IEC 60601-2-33: 2010+A1:2013+A2:2015)	4W/kg for whole body (1st operating mode specified in IEC 60601-2-33: 2010+A1:2013)	Same
Maximum dB/dt	1st operating mode specified in IEC 60601-2-33: 2010+A1:2013+A2:2015	1st operating mode specified in IEC 60601-2-33: 2010+A1:2013	Same

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Item	Subject Device:Vantage Galan 3T, MRT-3020,V6.0 with AiCE ReconstructionProcessing Unit for MR	Predicate Device:Vantage Galan 3.0T,MRT-3020/A7, V5.0	Notes
Potential emergencycondition and meansprovided forshutdown	Shutdown by Emergency RampDown Unit for collision hazardfor ferromagnetic objects	Shutdown by Emergency RampDown Unit for collision hazardfor ferromagnetic objects	Same

20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K181953.

21. INDICATIONS FOR USE

. 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

Risk Management activities for new software functionalities are included in this submission. The test methods used are the same as those submitted in the previously cleared submissions of the predicate device, Vantage Galan 3T, MRT-3020/A7, V5.0 (K181953). A declaration of conformity with design controls is included in this submission.

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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 (when combining with Vantage Galan 3T, MRT-3020, V6.0)

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012
IEC60601-1-2 (2014)
IEC60601-1-6 (2010), Amd.1 (2013) ●
IEC60601-2-33 (2010), Amd.1 (2013), ● Amd.2 (2015)
IEC60825-1 (2007) ●
IEC62304 (2006), Amd.1 (2015) ●
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

AiCE deep learning reconstruction underwent both performance (bench testing) using a Model Observer study to determine that image Low Contrast Detectability was maintained or improved. Additionally a Human Observer study was conducted with 6 physicians and 160 images that demonstrated a statistical preference of AiCE when compared to other preferred filters. The results of the testing demonstrated that AiCE performed either at the same level or above the performance of commercially available predicate device.

25. SUBSTANTIAL EQUIVALENCE

Canon Medical Systems Corporation believes that the Vantage Galan 3T, MRT-3020, V6.0 Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR is substantially equivalent to the previously cleared predicate device referenced in this submission. Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Galan 3T, MRT-3020/A7, V5.0 are substantially equivalent to the previously cleared predicate devices.

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26. CONCLUSION

The modifications incorporated into the Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR 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

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.