The MRI 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. In addition, this system supports non-contrast 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 with Helios gradient (Model MRT-1504/U5) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan with Helios gradient uses the same magnet as the Vantage Titan (K120638). The gradient performance was modified using. the same gradient amplifier and gradient coil as Vantage Titan HSR (K112003).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modified MRI device (Vantage Titan with Helios gradient, model MRT-1504/U5). However, it does not contain the detailed information required to answer all parts of your request, specifically regarding acceptance criteria for device performance studies and the specifics of those studies (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

The submission focuses on establishing substantial equivalence to previously cleared predicate devices (K120638: Vantage Titan, K112003: Vantage Titan HSR) by highlighting hardware and software modifications and confirming safety parameters and imaging performance are maintained.

Here's a breakdown of what can be answered based on the provided text:

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

The document does not explicitly state "acceptance criteria" for imaging performance in a quantifiable way beyond affirming "Imaging Quality metrics utilizing phantoms are provided in this submission." Instead, it compares safety parameters to the predicate devices and states "No change from the previous predicate submission (K120638)." regarding imaging performance parameters.

Acceptance Criteria (Implied from Predicate Equivalence)	Reported Device Performance (Subject Device: Vantage Titan with Helios gradient, MRT-1504/U5)
Safety Parameters (Compared to Predicates)
Static field strength: 1.5T	1.5T
Peak and A-weighted acoustic noise: Comparable to predicates (Predicate K120638: 106.2 dB (A-weighted), 115.4 dB (peak); Predicate K112003: 113.0 dB (A-weighted), 121.6 dB (peak))	112.0 dB (A-weighted), 122.9 dB (peak)
Operational modes: 1st operating mode	1st operating mode
Safety parameter display: SAR, dB/dt	SAR, dB/dt
Operating mode access requirements: Allows screen access to 1st level operating mode	Allows screen access to 1st level operating mode
Maximum SAR: 4W/kg for whole body (1st operating mode, IEC 60601-2-33 (2002))	4W/kg for whole body (1st operating mode, IEC 60601-2-33 (2002))
Maximum dB/dt: <1st operating mode (IEC 60601-2-33 (2002))	<1st operating mode (IEC 60601-2-33 (2002))
Potential emergency conditions and means provided for shutdown: Shut down by Emergency Ramp Down Unit for collision hazard by ferromagnetic objects	Shut down by Emergency Ramp Down Unit for collision hazard by ferromagnetic objects
Biocompatibility of materials: Confirmed for electrodes and accessories for wireless gating	Confirmed for electrodes and accessories for wireless gating
Imaging Performance Parameters
No change from previous predicate submission (K120638).	No change from previous predicate submission (K120638).

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 states "Image Quality metrics utilizing phantoms are provided in this submission" and mentions "testing of the modified system was conducted in accordance with the applicable standards." However, it does not provide details on:

The specific sample size of phantoms used.
Whether any human subject data (test set) was used, and if so, its size or provenance (country of origin, retrospective/prospective). The studies appear to be primarily engineering validation based on standards and phantom imaging.

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. The focus is on technical performance specifications and substantial equivalence, not diagnostic accuracy studies involving expert interpretation of images for ground truth.

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

This information is not provided in the document, as no human-read test set requiring adjudication is described.

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

An MRMC study is not mentioned in the document. The device is an MRI system, not an AI-powered diagnostic tool, so such a study would not be expected or relevant to this submission.

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

This refers to AI algorithm performance. The device is an MRI system, not an AI diagnostic algorithm, so this is not applicable and not mentioned.

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

For the "Image Quality metrics utilizing phantoms," the ground truth would likely be established metrologically or by predefined physical properties of the phantoms.
For safety parameters, the ground truth would be the measurement against established safety standards (e.g., IEC 60601-2-33). No clinical ground truth (expert consensus, pathology, outcomes) is described.

8. The sample size for the training set

This is not applicable as the device is an MRI hardware system, not an AI model that requires a training set.

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

This is not applicable as the device is an MRI hardware system, not an AI model that requires a training set.

Summary

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ATTACHMENT G

Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Vantage Titan, v2.1, MRT-1504/U5

510(k) SUMMARY AND EFFECTIVENESS

DEC 1 3:2012

Page 1 of 5

1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.

1. ESTABLISHMENT REGISTRATION: 2020563

CONTACT PERSON AND U.S AGENT INFORMATION:

Charlemagne Chua Contact Person: (714) 730-5000

U.S. Agent Name:

Paul Biggins (714) 730-5000

2441 Michelle Drive Tustin, Ca. 92780

Establishment Name and Address:

MANUFACTURING SITE

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

Toshiba America Medical Systems, Inc.

Japan

5. DATE OF SUBMISSION:

1. DEVICE NAME:
  Generic Name: Model Name: Trade/ Proprietary Name: Magnetic Resonance Diagnostic Device MRT-1504/U5 Vantage Titan with Helios gradient

August 24, 2012 (Revised 11-5-2012)

7. CLASSIFICATION AND CLASS OF DEVICE

90-LNH, Class II per 21 CFR 892.1000

K122613-S1: Response to Al (10-9-12) Page 33 of 65

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PREDICATE DEVICE(S):

K120638: Vantage Titan, MRT-1504/U4
K112003: Vantage Titan HSR, MRT-1504/A5

REASON FOR SUMBISSION 9.

Modification of a cleared device

10. Submission Type Traditional 510(k)

11. DEVICE DESCRIPTION

12. INTEDED USE

The MRI system is 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 : In addition, this system supports non-contrast 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.

No changes from the previous submission, K120638

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Page 3 of 5

13. SUMMARY OF MAJOR HARDWARE CHANGES

Gradient Amplifier
Gradient Coil : b.

14. SUMMARY OF MAJOR SOFTWARE CHANGES

a. There are no software changes.

15. SUMMARY OF IMPROVEMENTS

MRS Scan a.
b. Altibase (Database SW), version upgrade

... ...

c. . Scan parameter window -----
ರ. Reconstruction speed
e. Locator window operation
Clinical application operability f.
Autoview GUI g.
Automatic map-scan h.
Implementation of 3D Advanced Fourier Imaging (AFI) i.
New coils (cardiac, Head, Spine and Flexible SPEEDER) i:

: : :

K122613-S1: Response to AI (10-9-12) Page 35 of 65

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Toshiba America Medical Systems, Inc.
Pre-Market Notification 510(k) Vantage Titan, v2.1, MRT-1504/U5

16. SAFETY PARAMETERS

	Vantage Titan withHelios gradient(Subject device)	Vantage Titan(K120638)	Vantage Titan HSR(K112003)
a. Static fieldstrength:	1.5T	1.5T	1.5T
b. Peak and A-weighted acousticnoise:	112.0 dB (A-weighed)122.9 dB(peak)	106.2 dB (A-weighted)115.4 dB (peak)	113.0 dB (A-weighted)121.6 dB (peak)
c. Operationalmodes:	1st operating mode	1st operating mode	1st operating mode
i. Safetyparameterdisplay:	SAR, dB/dt	SAR, dB/dt	SAR, dB/dt
ii. Operatingmode accessrequirements:	Allows screen access to1st level operating mode	Allows screen access to1st level operating mode	Allows screen access to1st level operating mode
d. Maximum SAR	4W/kg for whole body (1stoperating mode specifiedin IEC 60601-2-33 (2002))	4W/kg for whole body (1stoperating mode specifiedin IEC 60601-2-33 (2002))	4W/kg for whole body (1stoperating mode specifiedin IEC 60601-2-33 (2002))
e. Maximum dB/dt	<1st operating modespecified in IEC 60601-2-33 (2002)	<1st operating modespecified in IEC 60601-2-33 (2002)	<1st operating modespecified in IEC 60601-2-33 (2002)
f. Potentialemergencyconditions andmeans provided forshutdown:	Shut down by EmergencyRamp Down Unit forcollision hazard byferromagnetic objects	Shut down by EmergencyRamp Down Unit forcollision hazard byferromagnetic objects	Shut down by EmergencyRamp Down Unit forcollision hazard byferromagnetic objects
g. Biocompatibilityof materials	Confirmed for electrodesand accessories forwireless gating	Confirmed for electrodesand accessories forwireless gating	Confirmed for electrodesand accessories forwireless gating

16. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K120638).

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17. DESIGN CHANGE

The Vantage Titan with Helios gradient MRI System is comparable to the existing 1.5T Vantage Titan MRI System (K120638), with the following modifications.

Maximum gradient slew rate have been changed. a.
Maximum gradient strength has been changed. b.

18. SUMMARY OF DESIGN CONTROL ACTIVITIES

PS Risk List for software and hardware changes have been is included in this submission. The test methods used are the same as those submitted in the previously cleared submissions (K120638). A declaration of conformity with design controls is included in this submission.

19. TRUTHFUL AND ACCURACY CERTIFICATION

A certification of the truthfulness and accuracy of the Vantage Titan with Helios gradient described in this submission is provided in this submission.

20. SUBSTANTIAL EQUIVALENCE

Toshiba Medical Systems Corporation believes that the Vantage Titan with Helios gradient (model MRT-1504/U5). 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

IEC60601-1:1988, Amd.1:1991, Amd.2:1995
IEC60601-1-1:2000
IEC60601-1-2:2001, Amd.1:2004 ........
IEC60601-1-4:1996, Amd.1:1999
IEC60601-1-6:2006
IEC60601-1-8:2003,Amd.1:2006
IEC60601-2-33:2002, Amd.1:2005, Amd.2:2007
IEC60825-1: 2007
IEC62304:2006
IEC62366:2007
NEMA MS-1:2008
NEMA MS-2:2003
NEMA MS-3:2008
NEMA MS-4:2006
NEMA MS-5:2003
NEMA PS 3.1-18 (2008)

21. TESTING

Image Quality metrics utilizing phantoms are provided in this submission. Additionally, testing of the modified system was conducted in accordance with the applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices.

22. CONCLUSION :

The modifications incorporated into Vantage Titan with Helios Gradient (MRT-1504/U5), SW V2.20, do not affect the indications for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to the modifications,

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 13, 2012

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

Re: K122613

Trade/Device Name: Vantage Titan, MRT-1504/U5 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 5, 2012 Received: November 6, 2012

Dear Mr. Biggins:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rollowed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreate) to togen. Jo togen. Januaries date of the Medical Device Amendments, or to conninered prior to May 20, sire) 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). and Cosmetic rice (110) that the novice, subject to the general controls provisions of the Act. The I ou may, dierelore, manol of the Act include requirements for annual registration, listing of general obliations provision 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 I lease be advised that I Dr o levice complies with other requirements of the Act that I Drimas intatutes and regulations administered by other Federal agencies. You must or any I outlar statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K Fart 607); mooning (DI CFR 803); good manufacturing practice requirements as set de rice-relation daverse overles) (1 CFR Part 820); and if applicable, the electronic forth in the quality of evelsions (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris -S

Janine M. Morris 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):

Device Name:

Vantage Titan, MRT-1504/U5

Indications for Use:

Proton density (PD) (also called hydrogen density),

K122613

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.

Over-The-Counter Use AND/OR Prescription Use × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Janine M. Morris -S 2012.12.13 13:47:51 -05'00'

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

K122613 510(k) Number

Page 1 of _1

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.