The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, . TMJ, heart, blood vessels). {Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
Fluid Visualization .
2D / 3D Imaging ●
MR Angiography / MR Vascular Imaging .
. Water / Fat Imaging
Perfusion / Diffusion Imaging .

Device Description

The OPART™ /Ultra system is added into existing OAPRT™ series by incorporating the high performance gradient system. The OPART™ /Ultra system and the OPART™ system with Ultra gradient upgrade kit offers the modified sequences for the faster acquisition than existing OPART™ systems.

AI/ML Overview

The provided text describes a 510(k) submission for a Magnetic Resonance Diagnostic Device Accessory, the OPART™/Ultra, and its upgrade kit. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as would be found for a novel device. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment, is not present in the provided text.

However, I can extract and present the information that is available.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present "acceptance criteria" in a quantitative format for imaging performance. Instead, it compares safety parameters of the new device (OPART™/Ultra) against its predicate (OPART™) and other substantially equivalent devices. The "performance" here refers to physical and operational characteristics rather than diagnostic accuracy.

Parameter	OPART™ (Predicate, K993574)	OPART™/Ultra (Reported Performance)
Static field strength	0.35 T	0.35 T (Same)
Peak acoustic noise	108 dB	115.4 dB
A-weighted acoustic noise	98.4 dB(A)	102.5 dB(A)
Operational modes	Normal operating mode	Normal operating mode (Same)
Safety parameter display	SAR	SAR (Same)
Operating mode access requirements	Not applicable (only normal operating mode)	Not applicable (Same)
Maximum SAR	< 1.5 W/kg	< 1.5 W/kg (Same)
Maximum dB/dt	19 T/sec	51 T/sec
Gradient coil dimensions	1050 x 1175 x 51 mm	1050 x 1175 x 50 mm
Potential emergency conditions	Shut down by Emergency Ramp Down Unit for collision hazard by ferromagnetic objects	Same
Biocompatibility of materials	Not applicable	Not applicable (Same)

A note on "acceptance criteria": For a 510(k) submission like this, the "acceptance criteria" for safety parameters are often implicitly that the new device's performance remains within acceptable safety limits, or that any changes do not adversely affect safety and are appropriately documented. The increases in acoustic noise (115.4 dB Peak, 102.5 dB A-weighted) and maximum dB/dt (51 T/sec) for the OPART™/Ultra are noted, and the document states that TOSHIBA performed "dB/dt and acoustic noise verifications," implying these increases were evaluated for safety and deemed acceptable for the intended use. The core "acceptance criterion" for the overall device is substantial equivalence to legally marketed predicate devices.

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

The document does not describe a "test set" in the context of diagnostic performance evaluation with patient data. The evaluations mentioned are primarily engineering-based verifications of physical parameters and comparisons to predicate device specifications. There is no mention of patient data being used for device performance testing in this document.

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

Not applicable. As no diagnostic performance study utilizing patient data and ground truth is described, there's no mention of experts or their qualifications.

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

Not applicable, as no diagnostic performance study 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

Not applicable. This is a submission for an MRI system and its upgrade, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned.

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

Not applicable. This document is about a hardware and software upgrade for an MRI system, not a standalone algorithm.

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

Not applicable, as no diagnostic performance study requiring ground truth is described. The "ground truth" for the engineering parameters would be the actual measured values of the physical characteristics (e.g., static field strength, acoustic noise, SAR, dB/dt).

8. The sample size for the training set

Not applicable. This document does not describe a machine learning algorithm that requires a training set. The software changes are related to system control, improved user interface, and new or modified acquisition sequences.

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

Not applicable, as no training set for a machine learning algorithm is discussed.

Summary

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Ko 23207

OCT 0 9 2002

Appendix 1

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. DEVICE NAME:
-----------------	--

Model Name:

Trade/Proprietary Name:

Magnetic Resonance Diagnostic Device Accessory

MRT-600EX

OPARTTM

including OPART™ /Ultra and Ultra gradient system upgrade kit

ESTABLISHMENT REGISTRATION: 2020563 2.

1. U.S. Agent Name and Address:
  TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DRIVE TUSTIN, CA 92780

Contact Person:

Manufacturing Site: Michaela Mahl (714) 730 - 5000

TOSHIBA CORPORATION MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

August 01, 2002 ട. DATE OF SUBMISSION:

DEVICE DESCRIPTION 6.

Model Number with suffix	Trade/Proprietary Name
MRT-600EX /PR	OPART TM
MRT-600EX /UH	OPART TM /Ultra (Manual bed model)
MRT-600EX /U1	OPART TM /Ultra (Motorized bed model)
MZKT-GP0302 /U1	OPART TM Ultra gradient system upgrade kit

The following five versions have the same base software features with certain additional features available in each subsequent version (see Comparison Table, Appendix 7, for detailed description). A brief description follows:

V4.0: V4.00 onto v3.0 (K993574)

V4.1: V4.00 onto v3.1 (K993574)

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V4.00 onto v3.2 (K993574) V4.2:

V4.3: V4.00 onto v3.3 (K993574)
Based on v3.3 (K993574) with addition of fast acquisitions. This software is only V4.4: available for OPART™ /Ultra system.

A brief summary of the changes are described below:

SUMMARY OF MAJOR HARDWARE CHANGES 6.1.

A. For the OPART™ /Ultra system, the existing gradient amplifier in the control cabinet is eliminated and the high performance gradient power supply is added as a stand alone cabinet.

B. For the OPART™ /Ultra system, the cooling pipes are integrated into the gradient coils.

C: All the OPART™ standard configuration has only Open TX coil and QD Head coil, and other RF coils are moved to the options.

D. QD/Array Neck coil (K000549) is added in the optional items.

E. OD/Array Shoulder coil (K013854) is added in the optional items.

F. QD C/T/L Array Spine coil (K(X00002) is added in the optional items.

6.2. SUMMARY OF MAJOR SOFTWARE CHANGES

A. Improved user interface. (for V4.0, V4.1, V4.2, V4.3, V4.4)

B. High performance gradient power supply control (only for V4.4)

C. Single Shot EPI (SS-EPI) (only for V4.4)

D. Advanced Steady State Free Precession (SSFP) (only for V4.4)

E. Super FASE, shorter . TE version of FASE. (only for V4.4)

SAFETY PARAMETERS 7.

	OPART™ (No changes from theprevious submission, K993574)	OPART™ /Ultra
a. Static field strength:	0.35 T	Same
b. Peak and A-weighted acousticnoise:	108 dB (Peak)98.4 dB(A-weighted)	115.4 dB (Peak)102.5 dB(A-weighted)
c. Operational modes:i. Safety parameter display:ii. Operating mode accessrequirements:	Normal operating modeSARNot applicable because usedonly in normal operating mode	SameSameSame
d. Maximum SAR	< 1.5 W/kg	Same
e. Maximum dB/dtand Gradient coil dimensions:	19 T/sec1050 x 1175 x 51(unit: mm)	51 T/sec1050 x 1175 x 50(unit: mm)
f. Potential emergency conditionsand means provided for shutdown:	Shut down by Emergency RampDown Unit for collision hazardby ferromagnetic objects	Same
g. Biocompatibility of materials:	Not applicable	Same

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IMAGING PERFORMANCE PARAMETERS 8.

No changes from the previous submission, K993574.

INTENDED USE

1 No changes from the previous submission, K993574.

10. EQUIVAALENCY INFORMATION

TOSHIBA Corporation Medical Systems Company believes that the OPART™ /Ultra (model MRT-600EX/UH, MRT-600EX/U1) Magnetic Resonance Imaging (MRI) system or the OPART™ system with Ultra upgrade kit (MZKT-GP0302/U1) is substantially equivalent to the OPART™ (model MRT-600) (K993574) cleared on January 18, 2000 except for Gradient System. As for the Gradient System on OPART™ /Ultra system, it is substantially equivalent to the Gradient System on EXCELART™ with Pianissimo. The hardware configuration is substantially equivalent to model MRT-1501 /P2 system (K993803) cleared on February 4, 2000 and the gradient performance such as the maximum slew rate and gradient strength is substantially equivalent to model MRT-1501 /P3 system (K002531) cleared on October 26, 2000. The difference of the gradient performance by using the substantially equivalent hardware with MRT-1501 /P2 is due to the difference of the gradient coil design. The OPART™ /Ultra has the similar gradient performance to MRT-1501 /P3 with the hardware configuration substantially equivalent to MRT-1501 /P2 except for the gradient coil.

TOSHIBA Corporation Medical Systems Company also performed the dB/dt and acoustic noise verifications on OPART™ /Ultra system.

The new Gradient System offers advantages of faster acquisitions, but does not change the system's intended use. Good Manufacturing Practices requirements and software development procedures are unchanged from those already in effect for the EXCELART™ with Pianissimo.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 9 2002

Toshiba America Medical Systems, Inc. % Mr. Mark Job 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891 Re: K023207

Trade/Device Name: Opart™ (including Opart Ultra and Ultra Gradient Upgrade Kit) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH

Dated: September 24, 2002 Received: September 25, 2002

Dear Mr. Job:

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 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); 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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Page 2

This letter will allow you to begin marketing 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Henry C. Higdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 1

Page - 1

510(k) Number (if known):

Device Name: OPART™ (including OPART™/Ultra and Ultra gradient system upgrade kit)

Indications for Use:

Imaging of:

The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, . TMJ, heart, blood vessels). {Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
Fluid Visualization .
2D / 3D Imaging ●
MR Angiography / MR Vascular Imaging .
. Water / Fat Imaging
Perfusion / Diffusion Imaging .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Thos. F. Hagerman

Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number

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.