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 II MRI Magnetic Resonance Diagnostic Device is being enhanced by one additional RF Coil (Shoulder Coil) to increase the clinical utility of the AIRIS II in the stationary configuration. The Shoulder Coil can operate either in the quadrature mode or in the phased array mode with the AIRIS II.

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

AI/ML Overview

This appears to be a 510(k) summary for a new RF coil (Shoulder Coil) for an existing MRI system (Hitachi AIRIS II), not a study evaluating the performance of a new medical device in the typical sense of AI/image analysis. The document details the technical characteristics and intended use of the coil, emphasizing its substantial equivalence to a predicate device.

Therefore, many of the requested items (acceptance criteria, device performance metrics, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable in the context of this specific regulatory submission.

Here's why and what information can be extracted:

Reasoning for Non-Applicability:

Device Type: The device is an accessory RF coil for an MRI system, not a software algorithm, diagnostic AI tool, or a novel imaging modality requiring extensive clinical endpoint studies.
Regulatory Pathway: A 510(k) submission for an accessory like this primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device. This typically involves technical comparisons (e.g., design, materials, performance specifications) rather than new clinical trials with detailed performance metrics against ground truth.
Nature of the Document: This is a summary of safety and effectiveness, outlining the device's characteristics and intended use, not a detailed scientific report of a performance study.

Information that can be extracted or inferred:

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

Acceptance Criteria: For an RF coil, the acceptance criteria are generally focused on technical performance and safety, demonstrating that it functions as intended and does not introduce new risks compared to the predicate device. These are implicitly assumed to be met for 510(k) clearance based on the substantial equivalence argument.
- Implicit Acceptance Criteria (based on 510(k) of an MR accessory):
  - RF Coil Uniformity (mentioned as an imaging capability)
  - Compatibility with AIRIS II MRI system software and hardware.
  - Ability to produce diagnostic quality images of the shoulder and other large joints.
  - Safety standards for MR coils (e.g., SAR limits, heating, noise).
  - Performance comparable to legally marketed predicate devices.
Reported Device Performance: The document does not report specific performance metrics from a study in the way an AI algorithm might report sensitivity/specificity. Instead, it states that:
- "The QD Shoulder Coil provides imaging of the shoulder articular anatomy and other large joints."
- It operates "either in the quadrature mode or in the phased array mode."
- "AIRIS II software did not need to be revised in order to support full functionality of these coils."
- It is "Identical to the Predicate Device" in technological characteristics.

Table (Best Effort based on available info):

Acceptance Criteria (Inferred for MR RF Coil)	Reported Device Performance
RF Coil Uniformity (Diagnostic Quality)	Mentioned as an "Imaging Capability," implying it meets standards.
Compatibility with AIRIS II MRI system	"AIRIS II software did not need to be revised." Fully supported.
Ability to image specified anatomical regions	"Provides imaging of the shoulder articular anatomy and other large joints."
Safety (e.g., SAR, heating)	Implicitly met through substantial equivalence to predicate.
Substantial Equivalence to Predicate Device (AIRIS II with Shaped Shoulder Coil)	"Identical to the Predicate Device" in technological characteristics.

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

Not Applicable. This document does not describe a clinical performance study with a test set of patient data to evaluate a diagnostic algorithm. The clearance is based on technical specifications and substantial equivalence.

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

Not Applicable. See point 2. Ground truth establishment for diagnostic performance is not relevant for this type of regulatory submission.

4. Adjudication method for the test set

Not Applicable. See point 2.

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 an RF coil, not an AI or diagnostic algorithm. No MRMC study was performed or is relevant for this type of device.

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

Not Applicable. This is an RF coil, not a standalone algorithm.

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

Not Applicable. Ground truth for diagnostic performance is not relevant for this type of device and submission. The "ground truth" for an RF coil is its physical and technical performance specifications and its ability to consistently produce images as expected.

8. The sample size for the training set

Not Applicable. This is an RF coil, not a machine learning model. No training set is involved.

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

Not Applicable. See point 8.

Summary

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K984278

DEC | | 1998

Attachment 1 510(k) Summary of Safety and Effectiveness

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SUBMITTER INFORMATION: 1.0

Hitachi Medical Systems America Submitter: 1.1 1959 Summit Commerce Park Twinsburg, OH 44087 PH: 330 425-1313 FX: 330 425-1410
James Jochen Rogers 1.2 Contact:
November 19, 1998 Date: 1.3

DEVICE NAME: 2.0

Radiology 2.1 Classification Panel:
892.1000 Magnetic Resonance Diagnostic Device 2.2 Classification Number:
System, Nuclear Magnetic Resonance Imaging 2.3 Product Nomenclature:

90LNH 2.4 Product Code(s):

90MOS (Magnetic Resonance Specialty Coil)
AIRIS II Trade/Proprietary Name: 2.5
2.6 PREDICATE DEVICE(s):

Hitachi AIRIS II with Shaped Shoulder Coil

3.0 DEVICE DESCRIPTION:

FUNCTION 3.1
Identical to the AIRIS II 510(k) K974212.

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

3.2 SCIENTIFIC CONCEPTS

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 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.

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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.

DEVICE INTENDED USE: 4.0

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.

Anatomical Region: Head, Body, Spine, Extremities ●
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)

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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 shows the logo for the Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 11 1998

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

K984278 Re:

QD Multiple Array Shoulder Coil Part #MR-MSC-51Q/M Dated: November 3, 1998 Received: November 30, 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 (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 Ouality 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 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 vitto 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.ida.gov/cdrh/dsmaldsmam.html".

Sincerely yours,

Lillian Yiz, Ph.D.

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):

K984278

Device Name: Additional RF Coils for AIRIS II (Shoulder Coil)

Indications for Use:

The QD Shoulder Coil provides imaging of the shoulder articular anatomy and other large ioints.

The MR system is an imaging device, and is intended to provide the physician with r ho "ift" of count" information, obtained non-invasively and without the use of ionizing prodiation. 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-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.

Anatomical Region: Head, Body, Spine, Extremities
Proton Nucleus excited:
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

he Counter Use

Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K984278

1970 THORTOON THORTIN MAGS: 20 EC BC 77 950

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.