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

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 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan 3T uses 1.6m short and 6.4 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Titan 3T provides the maximum field of view of 50 x 50 x 45 cm.

The Vantage Titan 3T MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K080038), cleared January 22, 2008 with the following modifications.

. Field strength of magnet has been changed to 3T.
. RF amplifier, transmitter and receiver (RF cabinet) are modified to adopt the change in resonance frequency (63MHz -> 123MHz).
. Number of RF amplifier channels is increased from 1 to 2.
Number of receiver channels is 16ch for standard (same as Titan 1.5T), 32ch for optional. .
Software platform has been changed. .

AI/ML Overview

Below is an analysis of the provided text regarding the Toshiba America Medical Systems, Inc. AUG – 2 2011 Pre-Market Notification 510(k) MRT-3010/A5 Vantage Titan 3T.

Device Name: Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a comparison study for regulatory clearance (510(k) submission) to demonstrate substantial equivalence to a predicate device, rather than a clinical performance study with specific acceptance criteria in terms of diagnostic accuracy metrics. The "acceptance criteria" here are based on safety parameters outlined by recognized consensus standards and a qualitative assessment of imaging performance.

Acceptance Criteria (Predicate Device K080038)	Reported Device Performance (Vantage Titan 3T)
Safety Parameters:
Static field strength: 1.5 T	3T (Change accepted)
Peak and A-weighted acoustic noise:	111.8 dB (A-weighted)121.3 dB (peak)
105.7dB (A-weighted) 115.7dB (peak)	(Higher, but implied within acceptable safety limits for 3T, compliance to IEC 60601-2-33)
Operational modes: 1st operating mode (SAR, dB/dt display, access req.)	Same
Maximum SAR: 4 W/kg for whole body (1st operating mode, IEC 60601-2-33)	Same
Maximum dB/dt: <1st operating mode (IEC 60601-2-33)	Same
Gradient coil dimensions: 760 x 893 x 1405 mm	749 x 893 x 1405 mm (Slight change in inner diameter, accepted)
Potential emergency conditions & shutdown: Emergency Ramp Down Unit	Same
Biocompatibility of materials: Not applicable (for predicate)	Confirmed for electrodes and accessories for wireless gating (New feature, confirmed)
Imaging Performance Parameters:
(Implicitly, comparable diagnostic image quality to 1.5T predicate)	No changes from the previous submission, K080038. (Claim of equivalence)
Regulatory Compliance: Adherence to standards (IEC, NEMA, DICOM)	Testing done in accordance with applicable recognized consensus standards (IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-33(2002) + Amd.1 (2005) + Amd.2 (2007), NEMA MS1, MS2, MS3, MS4, MS5, ACR/NEMA DICOM 3.0)

The study primarily focuses on demonstrating that the new 3T system, despite changes in field strength and associated hardware/software, maintains the safety profile and "imaging performance" (qualitatively, meaning it produces diagnostically usable images) comparable to its predicate 1.5T device, while adhering to relevant international standards for medical electrical equipment.

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

The document states: "Additionally, volunteer studies were conducted to verify imaging performance."

Sample Size: Not specified. It only mentions "volunteer studies" (plural), suggesting more than one, but no specific number of volunteers is provided.
Data Provenance: Not explicitly stated, but given Toshiba Corporation is in Japan and the submission is to the US FDA, the volunteer studies could have been conducted in Japan, the US, or elsewhere. It is a prospective collection for the purpose of verifying imaging performance with the new device.

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

The document does not specify the number of experts used for reviewing the images from the volunteer studies.
It does mention the intended output: "When interpreted by a trained physician, these images yield information that can be useful in diagnosis." This implies that expert interpretation is expected for clinical use, but not for the "verification" process itself.
No qualifications for "experts" (if any were involved in verifying performance) are provided.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set (volunteer studies). The purpose of these studies was "to verify imaging performance," which likely refers to image quality and diagnostic utility, rather than specific diagnostic accuracy for a particular condition.

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

No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance.
This device is an MRI system itself, not an AI-powered diagnostic tool, so such a study would not be relevant to its regulatory clearance in this context. The comparison is between the new 3T MRI device and a previous 1.5T MRI device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (algorithm only) performance study was not done.
Similar to point 5, this device is a medical imaging system, not an AI algorithm. Its performance is evaluated on its ability to produce high-quality diagnostic images.

7. Type of Ground Truth Used for the Test Set

For the "volunteer studies," the "ground truth" was likely based on:

Qualitative assessment of image quality: Experts would likely assess image clarity, resolution, contrast, artifact levels, and overall diagnostic interpretability against established standards for MRI.
Physiological normalcy/absence of pathology in healthy volunteers: If healthy volunteers were used, the "ground truth" would be the expected normal anatomy and physiology, against which the MRI images would be evaluated for accuracy of representation.
It is not pathology, outcomes data, or expert consensus on specific disease diagnosis from the text provided, as it was for "verifying imaging performance" in volunteers.

8. Sample Size for the Training Set

Not Applicable. The Vantage Titan 3T is a hardware imaging system, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI models.
The software changes mentioned (new RF amplifier control, gradient power supply control, magnet supervisory control, modified SAR/distortion databases, new software platform) refer to engineering and control software, not AI training data.

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

Not Applicable. As explained in point 8, there is no "training set" for an AI algorithm in this context. The "ground truth" for the device's operational software would be derived from engineering specifications, physics principles, and established safety standards.

Summary

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Toshiba America Medical Systems, Inc. AUG – 2 2011 Pre-Market Notification 510(k) MRT-3010/A5 Vantage Titan 3T

Attachment 1

510(k) SUMMARY

Magnetic Resonance Diagnostic Device Accessory 1. DEVICE NAME: MRT-3010/A5 Model Name: Trade/Proprietary Name: Vantage Titan 3T

2. ESTABLISHMENT REGISTRATION:

U.S. Agent Name and Address: Toshiba America Medical Systems, Inc. 3. 2441 Michelle Drive Tustin, Ca 92780

Contact Person:	Paul Biggins(714) 730 - 5000
Manufacturing Site:	TOSHIBA CORPORATION

1. TOSHIBA CORPORATION lanufacturing Site: MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
ડ. August 30, 2010 DATE OF SUBMISSION: .

6. DEVICE DESCRIPTION

The Vantage Titan 3T MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K080038), cleared January 22, 2008 with the following modifications.

. Field strength of magnet has been changed to 3T.
. RF amplifier, transmitter and receiver (RF cabinet) are modified to adopt the change in resonance frequency (63MHz -> 123MHz).
. Number of RF amplifier channels is increased from 1 to 2.
Number of receiver channels is 16ch for standard (same as Titan 1.5T), 32ch for optional. .
Software platform has been changed. .

NOTE: The Filed Strength Vantage Titan 3T MRJ System is equivalent to that of the SIEMENS Verio, which is cleared on October 10, 2007 (K072237).

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Attachment 1

6.1. SUMMARY OF MAJOR HARDWARE CHANGES

Field strength of magnet has been changed to 3T. a.
RF amplifier, transmitter and receiver (RF cabinet) are modified to adopt the change in b. resonance frequency (63MHz -> 123MHz).
Number of RF amplifier channels is increased from 1 to 2. C.
Number of receiver channels is 16ch for standard (same as Titan 1.5T), 32ch for d. optional.
Cooling fan box is separated from filter cabinet. e.
Transformer cabinet has been modified to cover the system power requirement. f.
Wireless gating is added (optional). g.

SUMMARY OF MAJOR SOFTWARE CHANGES 6.2.

New RF amplifier cabinet control. a.
b. New gradient power supply control.
New Magnet supervisory control. c.
d. Modified the data base for SAR control for new WB coil.
Modified the data base for distortion correction and dB/dt calculation for new gradient e. coil.
f. New software platform.

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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) MRT-3010/A5 Vantage Titan 3T

K102484
p3/4

7. SAFETY PARAMETERS

Attachment l

	EXCELART Vantage Titan(K080038)	New Vantage Titan 3T
a. Static field strength:	1.5 T	3T
b. Peak and A-weightedacoustic noise:	105.7dB (A-weighted)115.7dB (peak)	111.8 dB (A-weighted)121.3 dB (peak)
c. Operational modes:i. Safety parameterdisplay:	1st operating modeSAR, dB/dt	Same
ii. Operating mode accessrequirements:	Allows access to 1st leveloperating mode	Same
d. Maximum SAR	4 W/kg for whole body (1stoperating mode specified in IEC60601-2-33 (2002))	Same
e. Maximum dB/dt	<1st operating mode specified inIEC 60601-2-33 (2002)	Same
and Gradient coildimensions:	760 x 893 x 1405(inner diameter x outer diameter xlength, unit: mm)	749 x 893 x 1405(inner diameter x outer diameterx length, unit: mm)
f. Potential emergencyconditions and meansprovided for shutdown:	Shut down by Emergency RampDown Unit for collision hazard byferromagnetic objects	Same
g. Biocompatibility ofmaterials:	Not applicable	Confirmed for electrodes andaccessories for wireless gating

8. IMAGING PERFORMANCE PARAMETERS

No changes from the previous submission, K080038.

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Attachment 1

9. INTENDED USE

· 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.

10. EQUIVALENCY INFORMATION

Toshiba Medical Systems Corporation believes that the Vantage Titan 3T (model MRT-3010/A5) Magnetic Resonance Imaging (MRI) System is substantially equivalent to the current Vantage Titan (model MRT-1504/S3) cleared on January 22, 2008 (K080038) except for magnetic field strength (3T instead of 1.5T). Field strength of this system is equivalent to that of SIEMENS Verio, which is cleared on October 10, 2007 (K072237).

Testing was done in accordance with applicable recognized consensus standards as listed below. Additionally, volunteer studies were conducted to verify imaging performance.

IEC 60601-1-1 IEC 60601-1-2 IEC 60601-2-33(2002) + Amd.1 (2005) + Amd.2 (2007) NEMA MS1, MS2, MS3, MS4, MS5 ACR/NEMA DICOM 3.0

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Toshiba Medical Systems Corporation, Japan % Mr. Paul Biggins Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

AUG - 2 2011

Re: K102489

Trade/Device Name: Vantage Titan 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH and MOS Dated: April 8, 2011 Received: April 18, 2011

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K102489

Indications for Use

510(k) Number (if known):

Device Name: Vantage Titan 3T

Indications for 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.

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.

Prescription Use (Part 21 CFR 801Subpart D) 801Subpart C)

Over-The-Counter Use (Part 21 CFR

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S Patel

(Division Sign Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K102-189

Company Confidential AUG 2010

510(k): Vantage Titan 3T Page 37 of 3857

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.