The Whole Body (including head, abdomen, pelvis, limbs and extremities, joints, spine, neck, -TMJ, heart, blood vessels, and breast). [Application terms include MRCP (MR Frida, nours, ever a reasony, MR Myeiography, MR Myeiography, 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 two upgrades to the MRT-50GP/E2 (FLEXART™) and MRT-50GP/H2 (FLEXART™/Hyper) system. The first is the V3.5 software, which is an upgrade over the V3.1 software. The second is the introduction of phased array coils into the coil lineup.

AI/ML Overview

The provided K970573 document describes an upgrade to existing Magnetic Resonance Imaging (MRI) systems (FLEXART™/FLEXART™/Hyper V3.5 software and new phased array coils). This submission focuses on demonstrating substantial equivalence to a previously cleared device (FLEXART™ V3.1) and enhanced performance without introducing new safety or efficacy questions.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which the device's performance is strictly measured in a quantitative manner for clinical efficacy. Instead, it focuses on demonstrating that the updated system maintains or improves upon the performance of the predicate device (V3.1) and adheres to general MRI safety parameters and consensus standards.

However, we can infer performance parameters that were evaluated for the upgrade:

Metric	Acceptance Criteria (Implied)	Reported Device Performance (V3.5)
Safety Parameters	Remain similar or within acceptable limits of predicate device
Max static field strength	Must be 1.5T	1.5T (Same as V3.1)
Rate of change of magnetic field	Must be 11 (13.3)T/sec	11 (13.3)T/sec (Same as V3.1)
Max. Radio frequency power deposition	Must be <0.4W/kg	<0.4W/kg (Increased from <0.34W/kg in V3.1, but still within acceptable safety limits)
Acoustic Noise levels	Must be 100.2 (98.5) dB Maximum	100.2 (98.5) dB Maximum (Same as V3.1)
Imaging Performance	Conformance to consensus standards for MRI image quality
Specification volume (Head)	At least 10 cm dsv	16cm dsv (Improved from 10 cm dsv in V3.1)
Specification volume (Body)	At least 20 cm dsv	28cm dsv (Improved from 20 cm dsv in V3.1)
Image Quality	Conformance to consensus standards for SNR, Uniformity, Slice Profiles, Geometric Distortion, Slice Thickness/Interslice Spacing	Demonstrated conformance via sample phantom and clinical images
Intended Use	Maintain or expand anatomical regions and diagnostic uses	Maintained and slightly expanded (due to new coils)

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

The document states: "Sample phantom images and clinical images were presented for new sequences and optional coils..."

Sample size: The specific number of "sample phantom images" and "clinical images" is not explicitly stated. It only mentions "sample" images.
Data provenance: The country of origin for the data is not explicitly stated. Given that Toshiba Corporation, the manufacturer, is in Japan, and the U.S. Agent is Toshiba America MRI, Inc., it is plausible the data could originate from either region or a combination. The document does not specify if the data was retrospective or prospective.

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

The document does not mention the use of experts to establish ground truth for the test set or their qualifications. The evaluation appears to be based on physical measurements and qualitative assessment ("demonstrating conformance"). This is typical for MRI system upgrades focusing on technical performance and image quality rather than diagnostic accuracy that would require expert reads.

4. Adjudication method for the test set

The document does not mention any adjudication method for the test set.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted based on the provided text. This submission is for an MRI system and software upgrade, not an AI-powered diagnostic tool, so such a study would not be applicable in this context. There is no mention of AI.

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

This is an MRI system and software upgrade, not a standalone AI algorithm. Therefore, no standalone algorithm performance study was conducted in the sense of an algorithm operating independently for diagnostic tasks. The "performance" refers to the system's ability to produce images of a certain quality, which humans then interpret.

7. The type of ground truth used

The ground truth used for evaluating the imaging performance parameters (SNR, Uniformity, Slice Profiles, Geometric Distortion, Slice Thickness/Interslice Spacing) were measurements and assessments against consensus standards requirements using phantom images and clinical images. For the general safety parameters, the ground truth was based on physical measurements (e.g., maximum static field strength, rate of change of magnetic field, RF power deposition, acoustic noise levels) compared against established safety limits.

8. The sample size for the training set

The concept of a "training set" is not applicable here as this is not a machine learning or AI-driven device requiring training data. The software upgrade improves image acquisition and processing techniques themselves, rather than learning from data.

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

As there is no training set for an AI algorithm, the question of establishing ground truth for a training set is not applicable.

Summary

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K970573

Image /page/0/Picture/1 description: The image shows the word "TOSHIBA" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word is horizontally oriented and appears to be a logo or brand name.

MERICA MEDICAL SYSTEMS, INC. RIVE, P.O. BOX 2068

510(k) Summary JUL 21 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

1.	Model Name:Device Name:Trade/Proprietary Name:	MRT-50GP/E2 and MRT-50GP/H2Magnetic Resonance DeviceFLEXART™/FLEXART™/Hyper V3.5
2.	Establishment Registration:	2936923
3.	U.S. Agent Name and Address:	TOSHIBA AMERICA MRI, INC.280 Utah Ave.South San Francisco, CA 94080
	Contact Person:	Steven M. Kay(714) 730-5000
4.	Manufacturing Site:	Toshiba Corporation1385 ShimoishigamiOtawara-shi, Tochigi-KenJapan 324

February 12, 1997 న. DATE OF SUBMISSION:

DEVICE DESCRIPTION 6.

7. SAFETY PARAMETERS [ ( ):FLEXART™/Hyper]

	V3.1	V3.5
Maximum static field strength:	1.5T	Same
Rate of change of magnetic field (τ = 1000ms):	11 (13.3)T/sec,	11 (13.3)T/sec.
Max. Radio frequency power deposition:	<0.34W/kg	<0.4W/kg
Acoustic Noise levels:	100.2 (98.5) dB	100.2 (98.5) dB
	Maximum	Maximum

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

		V3.1	V3.5
Specification volume:	Head:	10 cm dsv	16cm dsv
	Body:	20 cm dsv	28cm dsv

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

ರು. INTENDED USE

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

10. Equivalency Information

Toshiba America MRI, Inc. (TAMI) believes the FLEXART™ V3.5 software is substantially equivalent to the FLEXART™ V3.1 software because it consists of software upgrades that improve the image quality and performance of the FLEXART™, without introducing new questions of safety or efficacy. The FLEXART™ V3.1 was cleared by K962138. Although the new coils expand the indications for use, they do not change the intended use of the FLEXART™ system. Good Manufacturing Practices requirements are unchanged from those already in effect for V3.1 and the FLEXART™.

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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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized symbol that resembles an abstract human form or a bird in flight. The logo is black and white.

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: K970573 FLEXART™/FLEXART™/Hyper V3.5 Software .. .. .. .. Dated: February 12, 1997 Received: February 14, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

. . .

NI 21 007

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 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 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 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/odrh/dsmamain.blm!".

Sincerely yours,

W. Hiau Yhi

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

Enclosure

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510(k) Number (if known): _ _ K 970573

Device Name: __ Elexart™ (MRT-50GP) Version 3.5 Software_____

Indications for Use:

Imaging of:

The Whole Body (including head, abdomen, pelvis, limbs and extremities, joints, spine, neck, -TMJ, heart, blood vessels, and breast). [Application terms include MRCP (MR Frida, nours, ever a reasony, MR Myeiography, MR Myeiography, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
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	K970573
Prescription Use(Per 21 CFR 801.109)	✓
OR	Over-The-Counter Use

CONFIDENTIAL - 10

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.