Vantaqe 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 maqnetic 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

Contrast aqent use is restricted to the approved druq indications. When interpreted by a trained physician, these imaqes 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 and was cleared under K132160. This submission includes WFS (Water Fat Separation) software functionality and the optional subsystem, Saturn Gradient Option.

AI/ML Overview

The provided text is a 510(k) summary for the Toshiba Medical Systems Corporation's Vantage Titan 3T Magnetic Resonance Imaging (MRI) System. This submission is for modifications to an already cleared device, specifically adding WFS (Water Fat Separation) software functionality and an optional Saturn Gradient Option. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the new features meet specific clinical acceptance criteria.

However, I can extract information related to acceptance criteria and the type of study conducted for the new features, even if it doesn't detail specific performance metrics against clinical thresholds.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with specific quantitative thresholds for clinical performance or corresponding reported device performance metrics for the WFS software functionality or the Saturn Gradient Option.

Instead, the submission states:

"This testing demonstrated that the software performed as specified and did not raise new issues of safety and effectiveness."
"The additional software packages are work flow improvements and their performance was demonstrated to be equal to or better than the current methods for obtaining the same results."

These statements indicate that the "acceptance criteria" for these new features were likely focused on:

Functionality: The WFS software correctly separates water and fat images as intended.
Safety: No new safety concerns are introduced by the changes.
Equivalence/Non-inferiority: Performance is at least as good as, or better than, existing methods or the predicate device's performance for the same tasks.

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

Test Set Sample Size: The document only mentions "representative volunteer images" for the WFS software functionality. No specific number for the volunteer images or phantom studies is provided.
Data Provenance: Not explicitly stated, but typically, testing for such devices is conducted by the manufacturer, often using their own facilities or clinical partners. The country of origin for the manufacturing site is Japan. The nature of the study (retrospective/prospective) is not specified, but for new feature validation, it would typically involve prospective data acquisition.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the "representative volunteer images" or phantom studies. However, the "Indications for Use" section mentions that images are "interpreted by a trained physician," implying that expert interpretation is crucial for diagnostic use. For the validation of image quality, typically radiologists or other medical imaging specialists would be involved.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for evaluating the test set for the new features.

5. 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

This submission is for an MRI system with new software features, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with/without AI assistance is not applicable and was not performed. The "WFS (Water Fat Separation)" functionality is an image processing technique, not an AI interpretation tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense. The testing for the WFS software itself, particularly the "phantom studies," would constitute an evaluation of the algorithm's performance in a standalone manner, assessing its ability to correctly separate water and fat signals. The "representative volunteer images" would also assess the algorithm's performance on human data, but the evaluation of these images would implicitly involve a human observer (e.g., to confirm visual quality and separation). The document states, "This testing demonstrated that the software performed as specified," implying that the software's output was directly evaluated.

7. The Type of Ground Truth Used

Phantom Studies: For phantom studies, the ground truth is typically known and engineered into the phantom itself (e.g., known fat/water ratios in different compartments). This provides an objective measure of the algorithm's accuracy in separating these components.
Volunteer Images: For "representative volunteer images," the ground truth would likely be established through visual assessment by experts (e.g., confirming clear water/fat separation, absence of artifacts, and diagnostic quality) or potentially by comparing with established imaging sequences known to provide good fat/water separation. Pathology or outcomes data would not be the direct ground truth for this type of image processing feature.

8. The Sample Size for the Training Set

The document does not provide any information about a training set since the WFS functionality and gradient option are described as "software functionality" and "optional subsystem" being added to an existing, cleared MRI system. It does not suggest these features involved a machine learning model that required a specific training set in the conventional sense. If the WFS algorithm development involved any iterative refinement, details are not provided here.

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

As no training set is described for a machine learning model, this question is not applicable based on the provided text.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 9, 2015

Toshiba Medical Systems Corporation % Mr. Paul Biggins Director Regulatory Affairs/U.S. Agent 2441 Michelle Drive TUSTIN CA 92780

Re: K143008

Trade/Device Name: Vantage Titan 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: April 6, 2015 Received: April 7, 2015

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. 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-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.

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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/Resourcesfor You/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 yours.

Michael D'Hara

for

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K143008

Device Name

MRT-3010/A5, Vantage Titan 3T

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

Contrast aqent use is restricted to the approved druq indications. When interpreted by a trained physician, these imaqes yield information that can be useful in diagnosis.

Type of Use (Select one or both, as applicable)

ك Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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.

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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

2. ESTABLISHMENT REGISTRATION: 9614698

1. Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

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

U.S. Agent Name:

Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, Ca. 92780 (714) 699-7808

5. MANUFACTURING SITE:

Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

6. DATE OF SUBMISSION:

October 17, 2014

7. DEVICE DESCRIPTION:

7.1 SUMMARY OF HARDWARE CHANGES

Saturn Gradient Option with increased gradient field strength of 45mT/m.

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7.2 SUMMARY OF SOFTWARE CHANGES

a. WFS (Water Fat Separation) to provide water dominant images and fat dominant images.

8. SAFETY PARAMETERS

ltem	Vantage Titan 3T, V2.50	Vantage Titan 3T, V2.30	Notes
		K132160
	(subject device)	(Predicate Device)
Static field strength	3T	3T	Same
Operational Modes	Normal and 1st Operating	Normal and 1st Operating	Same
	Mode	Mode
i.Safety parameter	SAR dB/dt	SAR dB/dt	Same
display
ii. Operating mode	Allows screen access to	Allows screen access to	Same
access	1st level operating mode	1st level operating mode
requirements
Maximum SAR	4W/kg for whole body (1st	4W/kg for whole body (1st	Same
	operating mode specified	operating mode specified
	in	in
	IEC 60601-2-33(2010)	IEC 60601-2-33(2010)
Maximum dB/dt	<1st operating mode	<1st operating mode	Same
	specified in	specified in
	IEC 60601-2-33 (2010)	IEC 60601-2-33 (2010)
Potential	Shut down by Emergency	Shut down by Emergency	Same
emergency	Ramp Down Unit for	Ramp Down Unit for
condition and	collision hazard for	collision hazard for
means provided for	ferromagnetic objects	ferromagnetic objects
shutdown

8. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K132160).

9. INTENDED USE

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 (maqnetic 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:

Page 2 of 3

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

Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

No changes to the previously cleared indication (K132160).

10. SUMMARY OF DESIGN CONTROL ACTIVITIES

PS Risk List for software of changing packages are attached. The test methods used are the same as those submitted in the previously cleared submissions (K132160). A declaration of conformity with design controls is included in this submission.

11. TRUTHFUL AND ACCURACY CERTIFICATION

A certification of the truthfulness and accuracy of the Vantage Titan 3T described in this submission is provided in this submission.

12. SUBSTANTIAL EQUIVALENCE

Toshiba Medical Systems Corporation believes that the Vantage Titan 3T (model MRT-3010/A5) Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate devices referenced in this submission.

Testing was done in accordance with applicable recognized consensus standards as listed below.

List of Applicable Standards

IEC60601-1:2005
· IEC60601-1-2:2007
· IEC60601-1-8:2003,Amd.1:2006
IEC60601-2-33:2010
· IEC60825-1: 2007
· IEC62304:2006
IEC62366:2007
· NEMA MS-1:2008
NEMA MS-2:2008
· NEMA MS-3:2008
NEMA MS-4:2010
NEMA MS-5:2010
· NEMA PS 3.1-20 (2011)

Additional testing for WFS (Water Fat Separation) pulse sequence and software functionality included both phantom studies and representative volunteer images. This testing demonstrated that the software performed as specified and did not raise new issues of safety and effectiveness. The additional software packages are work flow improvements and their performance was demonstrated to be equal to or better than the current methods for obtaining the same results.

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.