The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, . spine, blood vessels , limbs and extremities). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac tagging.]
. Fluid Visualization
2D/3D Imaging
MR Angiography/MR Vascular Imaging
Blood Oxygenation Level Dependent (BOLD) Imaging .

Device Description

This submission consists of a new Magnetic Resonance Imaging system which is based primarily on the cleared VISART™/Hyper system (K965068) with modifications including a short bore magnet and gantry design. The software used with the EXCELART MRI system is V4 (K983110). All other technology used for the EXCELART system is the same as that of the cleared VISART™/Hyper system.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the EXCELART Magnetic Resonance Diagnostic Device Accessory (MRI System). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing independent clinical study results with detailed acceptance criteria and performance metrics for a new, non-inferiority claim.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert adjudications are not explicitly stated or applicable in the context of this 510(k) submission.

Here's an analysis of the provided information relative to your request:

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

The submission does not outline specific, quantitative acceptance criteria for image quality or diagnostic accuracy in the way a clinical study for a new AI device would. Instead, it demonstrates that the EXCELART system's safety and imaging performance parameters are comparable to its predicate device, the VISART™/Hyper system.

Parameter	Acceptance Criteria (Predicate)	Reported Device Performance (EXCELART)
Safety Parameters
Maximum static field strength	1.5T (VISART™/Hyper)	1.5T
Rate of change of magnetic field	19.5 T/sec. (VISART™/Hyper)	19.35 T/sec.
Maximum radio frequency power	<1.0 W/kg (VISART™/Hyper)	<1.0 W/kg
Acoustic noise levels (maximum)	105.1 dB (VISART™/Hyper)	110.8 dB
		Note: User cautioned to have patient wear acoustic noise protection.
Imaging Performance Parameters
Specification volume: Head	16cm dsv (VISART™/Hyper)	16cm dsv
Specification volume: Body	28cm dsv (VISART™/Hyper)	28cm dsv

Study to prove device meets acceptance criteria:

The "study" presented is less a formal clinical trial and more a comparison of technical specifications and design similarities to a previously cleared device. The core argument for meeting acceptance criteria (i.e., being safe and effective) is substantial equivalence to the VISART™/Hyper MRI system (K965068). The modifications (short bore magnet and gantry design) are stated to "not raise new questions of safety or efficacy."

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

Sample Size: Not applicable/not provided. This is a technical comparison for substantial equivalence, not a clinical study on a test set of patient data.
Data Provenance: Not applicable. The data primarily consists of engineering specifications and design details of the device itself, compared to a predicate device.

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

Number of experts & Qualifications: Not applicable. Ground truth as typically defined for clinical performance (e.g., diagnostic accuracy studies) is not established in this document. The "ground truth" for this submission is the established safety and efficacy of the predicate device (VISART™/Hyper) and the technical measurements of the EXCELART system itself.

4. Adjudication method for the test set

Adjudication method: Not applicable. There is no test set in the sense of patient cases requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

MRMC study: No. This document is a 510(k) submission for substantial equivalence based on technical specifications and design, not an MRMC comparative effectiveness study involving human readers or AI assistance.

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

Standalone performance: Not applicable. The EXCELART is an MRI system, not an AI algorithm.

7. The type of ground truth used

Type of ground truth: The "ground truth" for this submission is the established safety and effectiveness of the predicate device (VISART™/Hyper), as determined by previous FDA clearance, and the technical specifications and performance measurements of the EXCELART system demonstrating comparability. The software (V4, K983110) is also previously cleared.

8. The sample size for the training set

Training set sample size: Not applicable. This is not an AI/machine learning device that would have a training set.

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

Ground truth for training set: Not applicable. (As above, not an AI/ML device).

Summary

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MAY 1 4 1999

K990620

510(k) Premarket Notification

SUMMARY OF SAFETY AND EFFECTIVENESS

1.	DEVICE NAME:Model Number:	Magnetic Resonance Diagnostic Device AccessoryMRT-150 /V2 (EXCELART)
	Trade/Proprietary Name:	EXCELART
2.	ESTABLISHMENT REGISTRATION:	2636923
3.	U.S. AGENT NAME AND ADDRESS:	Toshiba America MRI, Inc.280 Utah AvenueSouth San Francisco, CA 94080
	CONTACT PERSON:	Ken Nehmer(650)872-2722 ext. 6083
4.	MANUFACTURING SITE:	Toshiba Corporation1385 ShimoisigamiOtawara-shi, Tochigi-KenJapan 324
5.	DATE OF SUBMISSION:	February 24, 1999
6.	DEVICE DESCRIPTION:	This submission consists of a new Magnetic ResonanceImaging system which is based primarily on the clearedVISART™/Hyper system (K965068) with modificationsincluding a short bore magnet and gantry design. Thesoftware used with the EXCELART MRI system is V4(K983110). All other technology used for the EXCELARTsystem is the same as that of the cleared VISART™/Hypersystem.
7.	SAFETY PARAMETERS:Maximum static field strength:	VISART™/Hyper1.5T	EXCELART1.5T

Rate of change of magnetic field:	19.5 T/sec.	19.35 T/sec.
Maximum radio frequency power	<1.0 W/kg	<1.0 W/kg
Acoustic noise levels (maximum):	105.1 dB	110.8 dB

Acoustic noise data was measured in accordance with NEMA guidelines. The user is cautioned to have the patient wear acoustic noise protection during scanning.

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8. IMAGING PERFORMANCE PARAMETERS:

Specification volume: Head:	VISART™/Hyper16cm dsv	EXCELART16cm dsv
Body:	28cm dsv	28cm dsv

9. INTENDED USE

Anatomical regions: Head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities Nuclei excited: Hydrogen Diagnostic use: Diagnostic imaging of the whole body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities), fluid visualization, 2D and 3D imaging, MR angiography/MR Vascular Imaging and MR fluoroscopy, Blood Oxygenation Level Dependent (BOLD) Imaging. [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac Tagging.}

10. EQUIVALENCY INFORMATION:

Toshiba America MRI, Inc. (TAMI), believes that the EXCELART Magnetic Resonance Imaging (MRI) system is substantially equivalent to the VISART™/Hyper Magnetic Resonance System (K965068) cleared on 7/15/1997. The software used for the EXCELART MRI system is the same as V4 (K983110). The short bore magnet and short gantry do not raise new questions of safety or efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 1999

Ken Nehmer Quality Engineer Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, California 94080 Re:

K990620 EXCELART MRI System Dated: February 24, 1999 Received: February 25, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Nehmer:

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 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). 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 III (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/2/Picture/14 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

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K990620 510(k) Number (if known): EXCELART MRI System __________________________________________________________________________________________________________________________________________________________ Device Name: Indications for Use:

Imaging of:

The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, . spine, blood vessels , limbs and extremities). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac tagging.]
. Fluid Visualization
2D/3D Imaging
MR Angiography/MR Vascular Imaging
Blood Oxygenation Level Dependent (BOLD) 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	K990620

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

CONFIDENTIAL

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.