The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, -The whole body (including reast). [Application terms include MR Fluoroscopy, MR Irography, MRCP (MR Cholangiopancreatography), MR Myelography, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
Fluid Visualization -
2D/3D Imaging -
MR Angiography/MR Vascular Imaging -

Device Description

This submission consists of three upgrades to the MRT-150/H1 and MRT-150/F1 (VISART™) system. The first upgrades the software from V3.1 (which was the software cleared with the VISART™ in K961092) to V3.5. The second is the introduction of the VISART™/Hyper system, which increases the gradient field strength over that of the standard VISART™ with V3.5 software. The third is the introduction of optional phased array coils.

AI/ML Overview

The provided text describes a 510(k) summary for a Magnetic Resonance Device (MRT-150/H1, MRT-150/F1, MRT-150/H2, MRT-150/F2, marketed as VISART and VISART/Hyper). It introduces upgrades to the software (from V3.1 to V3.5) and hardware (VISART/Hyper system with increased gradient field strength and optional phased array coils).

Here's an analysis based on the information provided, specifically addressing the questions you've posed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes safety and imaging performance parameters for the device. While explicit "acceptance criteria" for a study aren't clearly defined as pass/fail thresholds in the typical sense for a clinical study, the specifications listed for the upgraded devices represent the targeted performance that was demonstrated to be met.

Parameter (Acceptance Criteria)	Reported Device Performance (VISART™ V3.5)	Reported Device Performance (VISART™/Hyper V3.5)
Max static field strength	1.5T	1.5T
Rate of change of magnetic field (τ = 1000ms)	13.3T/sec	19.5T/sec
Max. Radio frequency power deposition	<1.0W/kg	<1.0W/kg
Acoustic Noise levels (Maximum)	105.3 dB	105.1 dB
Specification volume: Head	16 cm dsv	16 cm dsv
Specification volume: Body	28 cm dsv	28 cm dsv

2. Sample size used for the test set and the data provenance:

The document mentions "Sample phantom images and clinical images were presented for all new sequences".

Sample Size for Test Set: This is not explicitly stated in terms of the number of clinical images or patients.
Data Provenance: This is not explicitly stated. It's likely from Japan (where the manufacturing site is located) but not confirmed. The document does not specify if it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The submission focuses on technical specifications and device equivalency rather than a clinical study requiring expert ground truth for interpretation.

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

This information is not provided. As no clinical study requiring expert interpretation is described in detail, adjudication methods would not typically be mentioned.

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 MrMC comparative effectiveness study was reported. This submission predates the widespread integration of AI in medical imaging interpretation as described in the 510(k) summary (1996). The improvements mentioned are related to image quality provided by the updated device hardware and software, not AI assistance for human readers.

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

Not applicable/Not reported. This device is an MRI machine with upgraded software and hardware, not a standalone algorithm.

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

For the safety and performance parameters, the "ground truth" seems to be objective measurements against design specifications and consensus standards. For example:

Safety parameters (field strength, RF power, acoustic noise): Measured values against established safety limits and NEMA guidelines.
Imaging performance parameters (SNR, Uniformity, Slice Profiles, Geometric Distortion, Slice Thickness/Interslice Spacing): Demonstrated conformance with "consensus standards requirements" using phantom and clinical images.
No specific ground truth (expert consensus, pathology, outcomes data) for diagnostic accuracy is described since this filing is about device upgrades and equivalency, not a diagnostic accuracy claim for a specific clinical indication based on interpreted images.

8. The sample size for the training set:

Not applicable/Not reported. This document describes an MRI device upgrade, not a machine learning algorithm that requires a training set in the conventional sense.

9. How the ground truth for the training set was established:
Not applicable/Not reported. As above, this is an MRI device, not an AI algorithm requiring a training set.

Summary

{0}------------------------------------------------

1965068

JUL | 5 |997

510(k) Summary

SUMMARY OF SAFETY AND EFFECTIVENESS

1.	Model Name:	MRT-150/H1 and MRT-150/F1 MRT-150/H2 and MRT-150/F2
	Device Name:	Magnetic Resonance Device
	Trade/Proprietary Name:	VISART™ and VISART™/Hyper
2.	Establishment Registration:	#2020563
3.	U.S. Agent Name and Address:	TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92681-2068
	Contact Person:	Steven M. Kay (714) 730-5000
4.	Manufacturing Site:	Toshiba Corporation 1385 Shimoishigami Otawara-shi, Tochigi-Ken Japan 324

ર. DATE OF SUBMISSION: 16 December 1996

DEVICE DESCRIPTION 6.

{1}------------------------------------------------

7. SAFETY PARAMETERS

	VISARTTMV3.1	VISARTTMV3.5	VISARTTM/HyperV3.5
Maximum static field strength:	1.5T	Same	Same
Rate of change of magnetic field (τ = 1000ms):	13.3T/sec,	13.3T/sec.	19.5T/sec.
Max. Radio frequency power deposition:	<1.0W/kg	<1.0W/kg	<1.0W/kg
Acoustic Noise levels:(Maximum)	105.3 dB(Maximum)	105.3 dB(Maximum)	105.1 dB

Acoustic noise data was measured in accordance with NEMA guidelines. In the labeling, the user is cautioned to have the patient wear acoustic noise protection during scanning. The VISART™/Hyper system includes additional noise absorption foam inside.

8. IMAGING PERFORMANCE PARAMETERS

VISART™	VISART™	VISART™/Hyper
V3.1	V3.5	V3.5
Specification volume: Head:	10 cm dsv	16cm dsv	16cm dsv
Body:	20 cm dsv	28cm dsv	28cm dsv

Sample phantom images and clinical images were presented for all new sequences, demonstrating conformance with consensus standards requirements for Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion and Slice Thickness/Interslice Spacing.

9. INTENDED USE

Head, Body, Extremity, Spine, Neck, TMJ, and Heart Anatomical Region: Nuclei excited: Hydrogen Imaging of the whole body (including the head, abdomen, heart, Diagnostic Use: pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy

10. EQUIVALENCY INFORMATION

Toshiba America Medical Systems, Inc. (TAMS) believes that the VISART™ V3.5 software is substantially equivalent to the VISART™ V3.1 software because it consists of upgrades that improve the performance of the VISART™, without introducing new questions of safety or efficacy. The increased rate of change of the magnetic field is less than the Agency's acceptance limit of 20 T and that of other manufacturers systems currently on the market. This software upgrade provides improved image quality, but does not change the intended uses of the device. Good Manufacturing Practices requirements are unchanged from those already in effect for V3.1 and the VISART™

1 - 2

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Steven M. Kay Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92681-2068

Re: K965068 Software Version 3.5 and Hardware Upgrades For VISART Dated: April 15, 1997 Received: April 16, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

JUL 1 5 1997

Dear Mr. Kay:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to beeing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Sincerely yours,

Lillian Yiu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{3}------------------------------------------------

Page 2011 Coof Color

510(k) Number (if known): __________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Imaging of:

The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, -The whole body (including reast). [Application terms include MR Fluoroscopy, MR Irography, MRCP (MR Cholangiopancreatography), MR Myelography, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
ﻧﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ

Fluid Visualization -
2D/3D Imaging -
MR Angiography/MR Vascular Imaging -

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)
	Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K965068

Prescription Use		OR	Over-The-Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

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.