The Vantage Titan system is 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

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.

Device Description

The Vantage Titan (Model MRT-1510) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K150427. This system is based upon the technology and materials of previously marketed Toshiba MRI 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

The provided text does not contain detailed information about specific acceptance criteria, device performance metrics, or a formal study proving the device meets acceptance criteria in the way a clinical trial report would.

The document is a 510(k) summary for a software update to an MRI system (Vantage Titan 1.5T, MRT-1510, V3.6 Software). It asserts substantial equivalence to predicate devices based on safety and effectiveness, and highlights software changes and various testing activities.

Here's a breakdown of the available information in response to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) or quantitative reported device performance values. Instead, it states that:

Safety Parameters: The device's safety parameters (Static field strength, Operational Modes, SAR dB/dt display, Operating mode access requirements, Maximum SAR, Maximum dB/dt, Potential emergency condition and means provided for shutdown) are "Same" as the predicate device (Vantage Titan 1.5T, V3.1 (K150427)).
Imaging Performance Parameters: There is "No change from the previous predicate submission, K150427."
Conclusion: "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."

This indicates that the acceptance criteria for these aspects were likely the maintenance of equivalence to the predicate device's established performance and safety profiles. However, the exact quantitative criteria are not disclosed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench testing, phantom imaging, volunteer clinical imaging" but does not specify the sample size for human subjects (volunteers) or the data provenance (country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. It speaks generally about "Images ... when interpreted by a trained physician," but no details on experts for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

The document does not mention an MRMC comparative effectiveness study or any AI assistance for human readers. The software updates primarily concern new pulse sequences and automatic positioning assistance (NeuroLine+, CardioLine+, SureVOI), which enhance image acquisition and planning, not necessarily image interpretation by a human reader in an AI-assisted workflow.

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

This document describes an MRI system's software update, which is a diagnostic imaging modality. It does not refer to a standalone algorithm for diagnosis without human-in-the-loop performance. The indications state that images "yield information that can be useful in diagnosis" when "interpreted by a trained physician."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not explicitly state the type of ground truth used for specific performance evaluations. Given the nature of MRI systems, it would typically involve clinical assessments, expert review of images, and potentially correlation with other diagnostic modalities or pathology where applicable, but this is not detailed here.

8. The sample size for the training set

The document does not specify a training set size. The software changes involve new pulse sequences and automatic positioning assistance, which would be developed and validated through a combination of engineering testing, phantom studies, and "volunteer clinical imaging," but a distinct "training set" per machine learning terminology is not mentioned.

9. How the ground truth for the training set was established

Since a training set with explicitly established ground truth (in the machine learning sense) is not described, this information is not provided.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

August 23, 2016

Toshiba Medical Systems Corporation % Janine Reves Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K160632

Trade/Device Name: Vantage Titan 1.5T, MRT-1510, V3.6 Software Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 27, 2016 Received: July 29, 2016

Dear Ms. Reyes:

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,

Jeff Bollyea

For Robert Ochs, Ph.D. 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

K160632

510(k) Number (if known)

Device Name

Vantage Titan 1.5T, MRT-1510, V3.6 Software

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 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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------------------------------------------	---------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

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 1.5T
Model Number:	MRT-1510

2. SUBMITTER'S NAME:

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

3. OFFICIAL CORRESPONDENT:

Akinori Hatanaka Senior Manager, Regulatory Affairs and Vigilance

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

Contact Person:
Janine Faith Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive, Tustin, CA 92780 (714) 669-7853

5. MANUFACTURING SITE:

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

1. ESTABLISHMENT REGISTRATION: 9614698
1. Date Prepared:

July 27, 2016

U.S. Agent:

Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive, Tustin, CA 92780 (714) 669-7808

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HIBA AMERICA MEDICAL

8. DEVICE NAME:

Vantage Titan 1.5T, MRT-1510, V3.6 Software

9. TRADE NAME(S):

Vantage Titan 1.5T

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:

Primary Predicate Device (system): Vantage Titan 1.5T, MRT-1510, V3.1 Reference Predicate Device (added software functionalities): Vantage Titan 3T, MRT-3010, V3.5

	Subject	Primary Predicate	Reference Predicate
System	Vantage Titan 1.5T,MRT-1510, V3.6	Vantage Titan 1.5T,MRT-1510, V3.1	Vantage Titan 3T,MRT-3010, V3.5
Marketed By	Toshiba AmericaMedical Systems	Toshiba AmericaMedical Systems	Toshiba AmericaMedical Systems
510(k) Number	This Submission	K150427	K152371
Clearance Date		April 17, 2015	October 23, 2015

15. REASON FOR SUBMISSION

Modification of a cleared device.

16. DEVICE DESCRIPTION

17. SUMMARY OF HARDWARE CHANGES

No change from the previous predicate submission, K150427.

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TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

18. SUMMARY OF SOFWARE CHANGES

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

UTE (Ultra Short TE) pulse sequence ●
MP-RAGE pulse sequence
T2:mEcho and T2*mEcho pulse sequence ●
. Improvements in MRS
Multi b-value DWI
NeuroLine+ (automatic positioning assistance for neuro)
CardioLine+ (automatic positioning assistance for cardiac)
SureVOI (automatic cardiac planning assistance)
eFSBB (phase-enhanced FSBB filter) ●
Temporal Filter

19. SAFETY PARAMETERS

Item	Subject Device: Vantage Titan1.5T, V3.6	Predicate Device: VantageTitan 1.5T, V3.1 (K150427)	Notes
Static field strength	1.5T	1.5T	Same
Operational Modes	Normal and 1st Operating Mode	Normal and 1st Operating Mode	Same
i. Safety parameterdisplay	SAR dB/dt	SAR dB/dt	Same
ii. Operating modeaccess requirements	Allows screen access to 1st leveloperating mode	Allows screen access to 1st leveloperating mode	Same
Maximum SAR	4W/kg for whole body (1stoperating mode specified inIEC 60601-2-33(2010))	4W/kg for whole body (1stoperating mode specified inIEC 60601-2-33(2010))	Same
Maximum dB/dt	<1st operating mode specifiedin IEC 60601-2-33 (2010)	<1st operating mode specifiedin IEC 60601-2-33 (2010)	Same
Potential emergencycondition and meansprovided for shutdown	Shut down by Emergency RampDown Unit for collision hazardfor ferromagnetic objects	Shut down by Emergency RampDown Unit for collision hazardfor ferromagnetic objects	Same

20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K150427.

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A AMERICA MEDICAL SYSTEMS. INC.

21. INDICATIONS FOR USE

The Vantage Titan system indicated for use as a diagnostic imaging modality that produces crosssectional 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.

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, K150427.

22. SUMMARY OF DESIGN CONTROL ACTIVITIES

PS Risk List for new software functionalities and pulse sequences are included in this submission. The test methods used are the same as those submitted in the previously cleared submissions of the primary predicate device, Vantage Titan 1.5T, MRT-1510, V3.1 (K150427), and the reference predicate device, Vantage Titan 3T, MRT-3010, V3.5 (K152371). A declaration of conformity with design controls is included in this submission.

23. SAFTEY

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. The changes to this device are limited to the application software that is being presented for review. As the hardware and related safety considerations remain unchanged from the previous submission no information related to these aspects are presented for the determination of safety. Performance and/or clinical testing are being provided to demonstrate the safety and effectiveness of the application software.

This device is in conformance with the applicable parts of the following consensus standards published by the International Electrotechnical Commission (IEC) for medical devices and the National Electrical Manufacturers Association (NEMA).

LIST OF APPLICABLE STANDARDS

. IEC62304:2006
IEC62366:2007 ●

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AMERICA MEDICAL SYSTEMS, INC.

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, is also included as part of this submission.

25. SUBSTANTIAL EQUIVALENCE

Toshiba Medical Systems Corporation believes that the Vantage Titan 1.5T, MRT-1510, V3.6 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate devices referenced in this submission. Toshiba Medical Systems Corporation believes that the changes incorporated into the Vantage Titan 1.5T, MRT-1510, V3.6 software are substantially equivalent to the previously cleared predicate devices.

26. CONCLUSION

The modifications incorporated into the Vantage Titan 1.5T, MRT-1510, V3.6 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

§ 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.