The MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

Device Description

The AIRIS MRI Magnetic Resonance Diagnostic Device is being enhanced by two additional RF Coils (QD HP [High Performance] Wrist Coil, and Shaped Shoulder Coil) to increase the clinical utility of the AIRIS in the stationary configuration.

The QD HP [High Performance] Wrist Coil P/N MR-QWC-51 is a new addition to the complement of coils intended for use with AIRIS. The coil utilizes a proprietary multiple receiver quadrature coil design for improved S/N Ratio.

The Shaped Shoulder coil P/N MR-SC-51 is identical to the Latchable Large Extremity coil, which was documented in a Memo-to-File document as identical to the original Large Extremity Coil for AIRIS, with the exception that the coil geometry has been curved for easier coil positioning over the anatomy of interest. Safety and effectiveness of the coil are unchanged from the original, and this coil will replace the original coil.

AIRIS software did not need to be revised in order to support full functionality of these coils.

AI/ML Overview

This document describes the submission K980691 for Additional RF Coils for AIRIS (QD HP Wrist, Shaped Shoulder) by Hitachi Medical Systems America. However, this submission focuses on establishing substantial equivalence for the coils as medical devices, not on a new AI/algorithm device that would typically have the detailed performance metrics requested in your prompt.

Therefore, many of the fields for acceptance criteria and study design are not applicable or cannot be determined from the provided text, as the submission is not for an AI diagnostic device. The provided text is a 510(k) summary for a Magnetic Resonance Diagnostic Device (AIRIS MRI) and associated RF coils, not an AI/ML product.

Here’s what can be extracted and what cannot:

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

Acceptance Criteria: Not explicitly stated as performance metrics in the way an AI/ML product would have (e.g., sensitivity, specificity). The acceptance criterion is "substantial equivalence" to the predicate device (Hitachi AIRIS).
Reported Device Performance:
- QD HP Wrist Coil: "New addition to the complement of coils intended for use with AIRIS. The coil utilizes a proprietary multiple receiver quadrature coil design for improved S/N Ratio." (No quantitative S/N ratio improvement stated, but "improved" implies enhanced performance).
- Shaped Shoulder Coil: "identical to the Latchable Large Extremity coil... Safety and effectiveness of the coil are unchanged from the original, and this coil will replace the original coil." (This implies performance is at least equivalent to the original coil).

Acceptance Criteria (Implicit for Substantial Equivalence of Coils)	Reported Device Performance
Maintain or improve Signal-to-Noise Ratio (S/N Ratio)	QD HP Wrist Coil: "improved S/N Ratio"
Maintain safety and effectiveness compared to existing coils	Shaped Shoulder Coil: "Safety and effectiveness of the coil are unchanged from the original"
Compatibility with AIRIS system without software revision	"AIRIS software did not need to be revised in order to support full functionality of these coils."
Continued ability of MR system for diagnostic use	The overall MR system's diagnostic uses (e.g., anatomical regions, nuclei excited, diagnostic uses, imaging capabilities) remain as defined in the "Indications for Use" section.

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

Not Applicable / Not Provided: This submission is for hardware components (RF coils) of an MRI system, not an AI diagnostic algorithm. There is no "test set" in the context of diagnostic performance metrics like those for AI. The evaluation would typically involve engineering tests, phantom studies, and possibly limited clinical imaging to confirm image quality and safety, but these details are not provided in this 510(k) summary.

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

Not Applicable / Not Provided: As this is not an AI diagnostic algorithm, there is no "ground truth" establishment by experts in the context of assessing diagnostic accuracy. The "trained physician" mentioned in the "Indications for Use" section refers to the end-user of the MRI system, not an expert panel for performance evaluation of the coils themselves for a 510(k) submission.

4. Adjudication method for the test set

Not Applicable / Not Provided: There is no "test set" or adjudication method described for performance evaluation in the context of diagnostic accuracy.

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 submission is not for an AI-assisted device. Therefore, no MRMC study or effect size related to AI assistance would be conducted or reported.

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

Not Applicable: This submission is for MRI hardware (coils), not an algorithm.

7. The type of ground truth used

Not Applicable / Not Provided: No "ground truth" as typically defined for diagnostic accuracy studies. The safety and effectiveness would be demonstrated through engineering specifications, comparison to the predicate, and possibly phantom studies or limited human subject imaging to confirm image quality.

8. The sample size for the training set

Not Applicable / Not Provided: This is not an AI/ML device, so there is no training set.

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

Not Applicable / Not Provided: No training set or associated ground truth.

Summary

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K180691

MAY | | 1998

Attachment 1 510(k) Summary of Safety and Effectiveness

: 上一篇:

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SUBMITTER INFORMATION: 1.0

Hitachi Medical Systems America 1.1 Submitter: 1959 Summit Commerce Park Twinsburg, OH 44087 PH: 330 425-1313 FX: 330 425-1410
- James Jochen Rogers 1.2 Contact:
- February 17, 1998 1.3 Date:

2.0 DEVICE NAME:

Radiology Classification Panel: 2.1
892.1000 Magnetic Resonance Diagnostic Device 2.2 Classification Number:
System, Nuclear Magnetic Resonance Imaging 2.3 Product Nomenclature:
90LNH Product Code(s): 2.4
- 90MOS (Magnetic Resonance Specialty Coil)
2.5 Trade/Proprietary Name: AIRIS
PREDICATE DEVICE(s): 2.6

Hitachi AIRIS

3.0 DEVICE DESCRIPTION:

FUNCTION 3.1

AIRIS software did not need to be revised in order to support full functionality of these coils.

SCIENTIFIC CONCEPTS 3.2

Magnetic Resonance (MR) is based on the fact that certain atomic nuclei have electromagnetic properties which cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen. which makes it the primary nucleus used in current imaging experiments in magnetic resonance. When placed in a magnetic field, there is a slight net orientation or alignment of these atomic nuclei with the magnetic field. The introduction of a short burst of radiofrequency (RF) excitation of wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a reorientation of the proton's magnetization vector. When the RF excitation is

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removed, the proton relaxes and returns to its original orientation. The rate of relaxation is exponential, and varies with the character of the proton and its adjacent molecular environment. This reorientation process is characterized by two exponential relaxation times called T1 and T2 which can be measured.

These relaxation events are accompanied by an RF emission or echo which can be measured and used to develop a representation of these emissions on a three dimensional matrix. Spatial localization is encoded into the echo by varying the RF excitation and by appropriately applying magnetic field gradients in x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of NMR characteristics of the nuclei under consideration can be constructed by using image processing techniques similar to those used in CT.

For magnetic fields up to 1.5T, the RF frequencies commonly used range up to 65MHz. The RF fields have pulse powers from several watts to greater than 10 kilowatts, and repeat at rates from once every few seconds to greater than fifty per second. The timevarying magnetic gradient fields have a typical duration of sub-millisecond to several milliseconds.

PHYSICAL AND PERFORMANCE CHARACTERISTICS 3.3

MR is currently of great interest because it is capable of producing high quality anatomical images without the associated risks of ionizing radiation. In addition, the biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In x-ray imaging, differences in x-ray attenuation, largely based on differences in electro density are responsible for the contrast observed in x-ray images. In MR imaging, differences in proton density, blood flow, and relaxation times T1 and T2 all may contribute to image contrast. In addition, by varying the duration and spacing of the RF pulses, images may be produced in which the contrast is primarily dependent on T1 relaxation, T2 relaxation, proton density, or a combination of all three.

4.0 DEVICE INTENDED USE:

● Anatomical Region:	Head, Body, Spine, Extremities
● Nucleus excited:	Proton
● Diagnostic uses:	2D T1-/T2-weighted imagingT1, T2, proton density measurementsMR Angiographyimage processing
● Imaging capabilities:	2D Spin Echo (SE); also with rephase

Spin Echo (SE); also with rephase

2D Gradient Field Echo (GE): also with rephase (2D GR)

2D Steady state acquisition with rewinded GE (SARGE); also with RF spoiling, rephasing

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2D Inversion Recovery (IR)

2D Fast Spin Echo (FSE); also with rephase

2D Fast Inversion Recovery (FIR)

2D Dual Slice acquisition (SEDS)

3D Spin Echo (SE)

3D Gradient Field Echo (GE)

3D Steady state acquisition with rewinded GE (SARGE); also with RF spoiling, rephasing

MR Angiography (2D TOF, 3D TOF, half echo, high resolution/high definition, sloped slab profile, magnetization transfer contrast)

MR Fluoroscopy

RF Coil Uniformity

Adaptive Image post-processing ACR/NEMA/DICOM 3 compliant

DEVICE TECHNOLOGICAL CHARACTERISTICS: 5.0

Identical to the Predicate Device.

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Image /page/4/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1998

James Jochen Rogers Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, Ohio 44087

Re:

K980691

QD HP Wrist and Shaped Shoulder Coils for Airis Magnetic Resonance Imaging System Dated: February 17, 1998 Received: February 23, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Rogers:

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 equivalient determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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/dsmaldsmamain.html".

Sincerely yours,

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

Enclosure

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Device Name: Additional RF Coils for AIRIS (QD HP Wrist, Shaped Shoulder)

Indications for Use:

The MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattion time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

Head, Body, Spine, Extremities Anatomical Region:
Nucleus excited: Proton
Diagnostic uses:
2D T1- / T2-weighted imaging T1, T2, proton density measurements MR Angiography image processing
Imaging capabilities:
2D Spin Echo (SE): also with rephase
2D Gradient Field Echo (GE); also with rephase (2D GR)
2D Steady state acquisition with rewinded GE (SARGE); also with RF spoiling, rephasing
2D Inversion Recovery (IR)
2D Fast Spin Echo (FSE); also with rephase
2D Fast Inversion Recovery (FIR)
2D Dual Slice acquisition (SEDS)
3D Spin Echo (SE)
3D Gradient Field Echo (GE)
3D Steady state acquisition with rewinded GE (SARGE); also with RF spoiling, rephasing
MR Angiography (2D TOF, 3D TOF, half echo, high resolution/high definition, sloped slab profile, magnetization transfer contrast)
MR Fluoroscopy
RF Coil Uniformity
Adaptive Image post-processing

ACR/NEMA/DICOM 3 compliant

(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 _ (Division Sign-Off)

Division of Reproductive Abdominal, ENT, and Radiological Devi 510(k) Number

(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.