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 vield 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(K113093). Four software packages (Positioning Assist for Cardiac, Diffusion Tensor Tractography (DTT) , Cardiac Function Analysis, and Image filter EM AIDR are added to Vantage Titan 3T.

AI/ML Overview

The provided text is a 510(k) summary for the Toshiba Vantage Titan 3T, v2.0 (MRT-3010/A5) MRI system. It describes the device and its intended use, focusing on software package additions to an already cleared predicate device (K113093). The document primarily addresses safety parameters and outlines the process of demonstrating substantial equivalence to the predicate device, especially regarding design control activities and adherence to recognized standards.

However, the document does not contain the specific information required to complete the table for acceptance criteria and device performance, nor does it provide details about a study designed to prove the device meets specific acceptance criteria in the way described in the prompt.

Here's why and what information can be extracted or inferred:

Acceptance Criteria and Reported Device Performance: This section is not explicitly present. The document focuses on showing the new device is "substantially equivalent" to a predicate device by comparing safety parameters (which are identical) and outlining that the new software additions are consistent with the predicate's intended use. It doesn't define new performance-based acceptance criteria for the added software packages (Positioning Assist for Cardiac, DTT, Cardiac Function Analysis, Image filter EM AIDR) nor report specific performance metrics against such criteria.
Study Design Information: The document states, "The test methods used are the same as those submitted in the previously cleared submissions (K113093). A declaration of conformity with design controls is included in this submission." This indicates that the validation relied on existing testing methodologies and design controls from the predicate device, rather than a new standalone study with a defined sample size, ground truth, experts, or adjudication methods for the specific software additions.

Therefore, the table and most of the detailed study questions cannot be answered from the provided text.

Inference/Extracted Information based on the provided text:

While a direct study with acceptance criteria is not detailed, the text implies that the "acceptance criteria" for the new software features were essentially demonstrating that they maintained the overall safety and imaging performance of the predicate device and performed their described functions as intended, within the framework of existing design controls. The study that "proves" this is the demonstration of substantial equivalence to the predicate device K113093, adhering to international standards for MR devices and software development.

Summary of what can be answered based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria (Not explicitly stated for new features; inferred from substantial equivalence to predicate)	Reported Device Performance (Inferred from substantial equivalence to predicate)
Safety Parameters	Identical to predicate K113093: Static field strength (3T), Operational Modes (1st Operating Mode), SAR dB/dt display, 1st level operating mode access, Max SAR (4W/kg whole body), Max dB/dt (<1st operating mode), Emergency shutdown means.	Met: All safety parameters are "Same" as predicate K113093.
Imaging Performance	"No change from the previous predicate submission (K113093)."	Met: Confirmed "No change" from predicate.
Functional Additions	(Implied) Proper operation of: Positioning Assist for Cardiac, Diffusion Tensor Tractography (DTT), Cardiac Function Analysis, Image filter EM AIDR (EMTONE) as described in the device description.	(Implied) Functions operate as described and are consistent with the intended use of the MRI system.
Standards Compliance	Adherence to a comprehensive list of IEC, NEMA, and other relevant standards.	Met: "Testing was done in accordance with applicable recognized consensus standards."

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

Not explicitly stated for the new software features. The document states: "The test methods used are the same as those submitted in the previously cleared submissions (K113093)." This implies reliance on the testing performed for the predicate device, but no specifics are given for the validation of the new software additions.

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):

Not stated. The document does not detail specific expert-based evaluations for validating the new software features.

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

Not stated.

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:

No, an MRMC comparative effectiveness study is not mentioned. The document describes software additions (Positioning Assist, DTT, Cardiac Function Analysis, an image filter AIDR), which are enhancements to an existing MRI system, not AI-assisted diagnostic tools requiring a reader study of this nature. "Image filter EM AIDR" is mentioned, which is an "image filter which can reduce the ringing artifact especially in low resolution images," this is a technical image processing feature, not necessarily an AI for diagnostic interpretation.

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

Not explicitly stated for the new software features in the context of performance metrics. The software changes are described as functional additions. The image filter would operate in a standalone manner on image data, but performance metrics for it are not provided here.

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

Not explicitly stated for the new software features. Given the nature of the software (positioning assist, DTI visualization, cardiac function analysis, image filter), ground truth would likely be based on physical phantom measurements, simulated data, and comparison to established clinical norms or pre-existing validated methods for the DTT and Cardiac Function Analysis.

8. The sample size for the training set:

Not applicable/Not stated. The software additions are described as functional packages and an image filter, not explicitly as machine learning algorithms that would require a "training set" in the common sense for AI/ML models.

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

Not applicable/Not stated. (See point 8).

Summary

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Toshiba Vantage Titan 3T, v2.0, MRT-3010/A

510(k) SUMMARY AND EFFECTIVENESS

1. DEVICE NAME:
  Generic Name: Model Name: Trade/ Proprietary Name:

Magnetic Resonance Diagnostic Device MRT-3010/A5 . Vantage Titan 3T

2. ESTABLISHMENT REGISTRATION: 2020563

3. U.S AGENT INFORMATION:

U.S. Agent Name:	Paul Biggins(714) 730-5000
Establishment Name and Address:	Toshiba America Medical Systems, Inc.2441 Michelle DriveTustin, Ca. 92780
4. MANUFACTURING SITE:	Toshiba Medical Systems Corporation1385 ShimoishigamiOtawara-shi, Tochigi 324-8550Japan
5. DATE OF SUBMISSION:	February 16, 2012

6. DEVICE DESCRIPTION:

6. SUMMARY OF MAJOR HARDWARE CHANGES Not applicable.

7. SUMMARY OF MAJOR SOFTWARE CHANGES

Existing software (V1.35) packages are grouped by functions of software and pulse sequences. New software (V2.0) packages are added four application software as follows:

a) Positioning Assist for Cardiac This function of software assists the operator to position for scanning for Cardiac imaging for easy operation. The operator shall confirm the patient position before
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starting the cardiac scanning and the operator can re-adjust the scanning position if needed.

b) Diffusion Tensor Tractography (DTT)
- i. DTT represents direction of the central nerves by using anisotropy of diffusion coefficients calculated from the DTI map.
- ii. The central nerves are represented as bundle fibers in 3D volume.
- iii. DTT can visualize the fusion of SVR with cut-off plan. DTI maps and bundle of fibers in 3D view.
  - a. SVR- is reconstructed Surface Volume Rendering image from anatomical images.
- iv. DTT can also visualize the fusion of cross sections, DTI maps and bundle of fibers
c) Cardiac Function Analysis

This function of software makes cardiac cine image and visual evaluation of wall motion abnormality. This function shows the graphs and tables of the result of cardiac function analysis like Bull's eye map of wall thickening.

d) Image filter EM AIDR
This is an image filter which can reduce the ringing artifact especially in low resolution images.

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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Vantage Titan 3T, v2.0, MRT-3010/A5

8. SAFETY PARAMETERS

Item	Vantage Titan 3T(subject device)	Vantage Titan 3TK113093(Predicate Device)	Notes
Static field strength	3T	3T	Same
Operational Modes	1st Operating Mode	1st Operating Mode	Same
i. Safety parameter display	SAR dB/dt	SAR dB/dt	Same
ii. Operating mode accessrequirements	Allows screen access to1st level operating mode	Allows screen access to1st level operating mode	Same
Maximum SAR	4W/kg for whole body (1stoperating mode specifiedinIEC 60601-2-33(2002))	4W/kg for whole body (1stoperating mode specifiedinIEC 60601-2-33(2002))	Same
Maximum dB/dt	<1st operating modespecified inIEC 60601-2-33 (2002)	<1st operating modespecified inIEC 60601-2-33 (2002)	Same
Potential emergencycondition andmeans provided forshutdown	Shut down by EmergencyRamp Down Unit forcollision hazard forferromagnetic objects	Shut down by EmergencyRamp Down Unit forcollision hazard forferromagnetic objects	Same

10. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K113093).

11. INTEDED USE

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

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Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images vield information that can be useful in diagnosis.
No changes to the previously cleared indication (K113093).

12. DESIGN CHANGE

Following software package addition to Vantage Titan 3T (K113093).

a) Positioning Assist for Cardiac
b) Diffusion Tensor Tractography (DTT)
c) Cardiac Function Analysis
d) Image filter EM AIDR (Development name is "EMTONE")

13. SUMMARY OF DESIGN CONTROL ACTIVITIES

PS Risk List for software of changing packages is included in this submission. The test methods used are the same as those submitted in the previously cleared submissions (K113093). A declaration of conformity with design controls is included in this submission.

14. 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.

15. 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

· IEC60601-1:1988, 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)

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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 features a stylized depiction of an eagle or bird in flight, rendered in black. The bird is composed of three curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird, with the words following the curve of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

MAY 2 3 2012

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

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

Re: K120487

Trade/Device Name: MRT-3010/A5, Vantage Titan 3T, v2.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH . Dated: April 12, 2012 Received: April 13, 2012

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 (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,

Janine M. Morris

Acting 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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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Vantage Titan 3T, v2.0, MRT-3010/A5

Indications for Use

510(k) Number (if known):

Device Name:

MRT-3010/A5, Vantage Titan 3T, v2.0

Indications for 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 vield information that can be useful in diagnosis

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

Aushurf O'thun

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

510(k) Number Kla0487

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Indication for Use Page 1 of 1

510(k): Vantage Titan 3T, v2.00 Page 15 of 2220

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.