Imaging of: The Whole Body (including head, abdomen, breast, 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

Device Description

The Large and Medium Flexible QD Body coils are essentially a QD (quadrature) extension and a flexible version of the standard Body Coil. The extension consists of adding a saddle trace to the existing solenoid trace. The two independent RF traces have RF magnetic fields which are orthogonal (oriented at 90 degrees with respect to each other) to create a quadrature coil. The NMR signals from the two independent loops are sent to an RF front end where they are then amplified and combined (summed) to provide a resultant signal with improved signal-to-noise ratio. With the coil's flexibility. RF connectors are added which enable the coil to open for patient loading. This enables the coil to be placed directly on the patient pallet. The standard body coil requires the patient to lay on the patient pallet then the patient with pallet is slid through the body coil. An advantage of placing the patient directly on the coil is that the pallet does not go through the coil. Hence the pallet is not filling the coil. This enables the coil to be physically smaller, for improved signal to noise, without losing space for patient loading.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a Magnetic Resonance Diagnostic Device Accessory (OPART™ MRT-600 Large and Medium Flexible QD Body coils).

This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device, not necessarily on proving that the device meets specific performance acceptance criteria through a rigorous independent study with defined metrics.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or how ground truths were established, as these are typically part of a comprehensive clinical study report, which is not included here.

Instead, the submission demonstrates "safety and effectiveness" by comparing the new device to a predicate device (Matrix 3000 Flexible Spine Coil, K964753) and stating that the modifications "do not raise new questions of safety or efficacy."

However, I can extract the safety and imaging performance parameters listed for the device, which might be considered "acceptance criteria" in a general sense for the device's operational characteristics, rather than diagnostic accuracy.

Here's a summary of what information is available in the provided text, structured to address your request as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, these are not diagnostic performance metrics, but rather operational specifications. The document implicitly states that the device meets these specifications as part of its design and intended function, making it substantially equivalent to the predicate.

Parameter	Acceptance Criteria (Stated Specification)	Reported Device Performance (Implied by design/equivalence)
Safety Parameters
Maximum static field strength	0.35 Tesla	0.35 Tesla
Rate of change of magnetic field	19 T/second	19 T/second
Maximum radio frequency power deposition (SAR)	<0.4 Watt/kg	<0.4 Watt/kg
Acoustic noise levels (maximum)	98.4 dB (A)	98.4 dB (A)
Imaging Performance Parameters
Specification volume (Head)	10cm dsv	10cm dsv
Specification volume (Body)	20cm dsv	20cm dsv

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

Sample Size for Test Set: Not applicable/not provided. The document mentions "Sample phantom images and clinical images are presented from both the Large Flexible QD Body coil (Appendix D & E) and the Medium Flexible QD Body coil (Add to file appendix 2 and 3)." This suggests internal testing for functionality and image quality, but not a formal clinical test set with statistical power calculations typically associated with diagnostic performance studies. The number of images or cases is not specified.
Data Provenance: Not specified. Given the context of a 510(k) for a device accessory, it's likely internal testing data.

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

Not applicable/not provided. This information is relevant for studies evaluating diagnostic accuracy, which is not the primary focus of this 510(k) submission for a coil accessory.

4. Adjudication method for the test set

Not applicable/not provided.

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 device accessory (MRI coil), not an AI diagnostic algorithm.

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

Not applicable. This is a device accessory (MRI coil), not an AI diagnostic algorithm.

7. The type of ground truth used

For the operational parameters (safety and imaging performance), the "ground truth" would be established through physical measurements, engineering tests, and adherence to established MRI system standards for signal detection within specified volumes. For image quality, it would likely be qualitative assessment against expected standards, as implied by the submission of "sample phantom images and clinical images." There is no mention of pathology, outcomes data, or expert consensus in a diagnostic sense.

8. The sample size for the training set

Not applicable/not provided. This is a hardware accessory, not a machine learning model requiring a training set.

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

Not applicable/not provided.

Summary

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

000000 241 1000 1

Kcj9007

510(k) Premarket Notification

SUMMARY OF SAFETY AND EFFECTIVENESS

1.	DEVICE NAME:	Magnetic Resonance Diagnostic Device Accessory
	Model Number:	MRT-600
	Trade/Proprietary Name:	OPART™
2.	ESTABLISHMENT REGISTRATION:	2636923
3.	U.S. AGENT NAME AND ADDRESS:	Toshiba America MRI, Inc.280 Utah Avenue
		South San Francisco, CA 94080
	CONTACT PERSON:	Ken Nehmer
		(650)872-2722 ext. 6083

MANUFACTURING SITE: USA Instruments, Inc. 4. 675-B Alpha Drive Highland Heights, Ohio 44143, USA
Establishment Registration: 1529041
DATE OF SUBMISSION: December 31, 1998 5.
DEVICE DESCRIPTION: The Large and Medium Flexible QD Body coils are essentially a QD 6. (quadrature) extension and a flexible version of the standard Body Coil. The extension consists of adding a saddle trace to the existing solenoid trace. The two independent RF traces have RF magnetic fields which are orthogonal (oriented at 90 degrees with respect to each other) to create a quadrature coil. The NMR signals from the two independent loops are sent to an RF front end where they are then amplified and combined (summed) to provide a resultant signal with improved signal-to-noise ratio.

With the coil's flexibility. RF connectors are added which enable the coil to open for patient loading. This enables the coil to be placed directly on the patient pallet. The standard body coil requires the patient to lay on the patient pallet then the patient with pallet is slid through the body coil. An advantage of placing the patient directly on the coil is that the pallet does not go through the coil. Hence the pallet is not filling the coil. This enables the coil to be physically smaller, for improved signal to noise, without losing space for patient loading.

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

SAFETY PARAMETERS:

Maximum static field strength:	0.35 Tesla
Rate of change of magnetic field:	19T/second
Maximum radio frequency power deposition (SAR):	<0.4 Watt/kg
Acoustic noise levels (maximum):	98.4 dB (A)

IMAGING PERFORMANCE PARAMETERS: 8.

Specification volume:	Head:	10cm dsv
	Body:	20cm dsv

Sample phantom images and clinical images are presented from both the Large Flexible QD Body coil (Appendix D & E) and the Medium Flexible QD Body coil (Add to file appendix 2 and 3).

INTENDED USE 9.

Anatomical regions:	Head, body, extremity, spine, neck, TMJ, breast, and heart
Nuclei excited:	Hydrogen
Diagnostic use:	Diagnostic imaging of the human body (including head, abdomen,breast, heart, pelvis, spine, blood vessels, limbs, and extremities),fluid visualization, 2D and 3D imaging, MR angiography and MRfluoroscopy.

10. EQUIVALENCY INFORMATION:

Toshiba America MRI, Inc., believes that both the Large and Medium Flexible QD Body Coil options for OPART™ system are substantially equivalent to the Matrix 3000 Flexible Spine Coil (K964753). The Large and Medium Flexible QD Body Coils are manufactured by USA Instruments, Inc. and is a modified version of USA Instruments Matrix 3000 Flexible Spine Coil.

The Large and Medium Flexible QD Body Coils are identical to the Matrix 3000 Flexible Spine Coil with some minor modifications added to allow for use with the OPART™ system. The modifications include changing capacitor values in order to shift the frequency to that used for the OPART™ imaging system (15Mhz). Additional tuning varactors were added for both tuning and matching. The original (Matrix 3000) design is variable tune with a fixed match scheme. For OPART™, the Large and Medium Flexible QD Body coils have variable tune and variable match. The interfacing cable was modified to accommodate more control lines for the varactors and coil ID. The signal lines of the coax portion of the cable is 50 ohms for both the Matrix 3000 and Large Flexible and Medium QD Body coils. Mechanically, both coils are identical. The modifications added to the coil do not raise new questions of safety or efficacy.

This optional coil does not introduce any new indications for use from those cleared in the Premarket Notification for OPART™ diagnostic resonance system 510(k) number K962933.

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

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized symbol resembling three overlapping human profiles or abstract shapes, positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1999 APR

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

K990007 Large and Medium Flexible OD Body Coil for Opart MRI System Dated: December 31, 1998 Received: January 4, 1999 21 CFR 892.1000/Procode: 90 MOS

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 marked predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Madical 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 (Special Controls) or 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 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 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

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

Page __ 1__ of __ 1__

了 ...

510(k) Number (if known):	K990007
Device Name:	OPART™ (MRT-600) Large and Medium Flexible QD Body Coils
Indications for Use:
Imaging of:

The Whole Body (including head, abdomen, breast, 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

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)

Prescription Use	✓
(Per 21 CFR§801.109)

Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number	K990007
---------------	---------

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.