The Altaire 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 ALTAIRE is a Magnetic Resonance Imaging System that utilizes a 0.7 Tesla superconducting magnet in an open gantry design. The design was based on the AIRIS II Open MRI system. The ALTAIRE has been designed to enhance clinical utility as compared to the AIRIS II by taking advantage of the imaging properties of the 0.7T magnet.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the ALTAIRE Magnetic Resonance Imaging System, presented in the requested format.

Important Note: The provided document is a 510(k) summary for a medical device cleared in 2002. At that time, the regulatory requirements for performance studies, particularly concerning detailed acceptance criteria and standalone AI performance, were significantly different and generally less stringent than for modern AI/ML medical devices. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than comprehensive performance studies as might be expected for novel AI tools today. Therefore, much of the requested information (like specific acceptance criteria, detailed study design for proving performance, expert adjudication, MRMC studies, or standalone algorithm performance) is not present in this type of submission.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Intended Use: Provide physiological and clinical information, obtained non-invasively and without ionizing radiation, for diagnosis determination by a trained physician. Produce transverse, coronal, sagittal, oblique, and curved cross-sectional images displaying internal structure of head, body, or extremities. Images reflect spatial distribution of protons exhibiting magnetic resonance (proton density, T1, T2, flow).	The ALTAIRE MR system functions as an imaging device, utilizing a 0.7 Tesla superconducting magnet. It produces images based on proton density, T1, T2, and flow, consistent with the scientific principles of MRI. The device's 'physical and performance characteristics' are generally described as being 'capable of producing high quality anatomical images'.
Substantial Equivalence: To Hitachi AIRIS II MRI System (K001334) and GE Signa OpenSpeed MRI System (K992746).	The submission concludes that the ALTAIRE MRI system is "substantially equivalent to the listed predicate device." The intended use is stated as "identical to the listed predicate device." The design was based on the AIRIS II, and the primary difference is "software enhancements."
Technological Characteristics: Similar to the primary predicate device, with inclusion of software enhancements.	The control and image processing hardware and base elements of the operating system software are identical to the primary predicate device. The software enhancements enhance clinical utility compared to the AIRIS II by taking advantage of the 0.7T magnet.
Safety: Implied by substantial equivalence to legally marketed devices.	Not explicitly stated as a performance metric, but substantial equivalence implies safety comparable to predicate devices.

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

Sample Size: Not applicable. The document does not describe a traditional "test set" or a performance study in the context of clinical accuracy or diagnostic performance involving a specific sample size of patients or images. The evaluation is centered on demonstrating substantial equivalence based on technical specifications and intended use.
Data Provenance: Not applicable. No specific clinical data from a test set is referenced for the comparison.

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

Not applicable. No ground truth establishment from experts for a dedicated test set is described. The evaluation is not based on direct clinical performance comparison of the new device's images against a ground truth dataset established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no described test set or adjudication process for diagnostic interpretations.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an MRI system, not an AI interpretation tool.

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

No, a standalone performance study in the context of an algorithm's diagnostic output was not done. The device is a diagnostic imaging system that requires human interpretation.

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

Not applicable. No specific ground truth for diagnostic accuracy is described in relation to a performance study for this device. The "ground truth" for substantial equivalence is the demonstration that its technical characteristics and intended use are similar to predicate devices.

8. The sample size for the training set

Not applicable. The document does not describe a "training set" in the context of machine learning. The device being submitted is an MRI system, not an AI/ML algorithm.

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

Not applicable. As there's no described training set related to AI/ML, there's no mention of ground truth establishment for it.

Summary

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KO2390

1.0 Submitter Information

1.1 Submitter: Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, Ohio 44080-2371 ph: (330) 425-1313 fax: (330) 425-1410

1.2 Contact: Douglas J. Thistlethwaite
1.3 Date: July 19, 2002

2.0 Device Name

Classification Name: 2.1 System, Nuclear Magnetic Resonance Imaging

Classification Number: 2.2 90LNH
Trade/Proprietary Name: 2.3 ALTAIRE Magnetic Resonance Imaging System
Predicate Device(s): 2.4 Hitachi AIRIS II MRI System (K001334) GE Signa OpenSpeed MRI System (K992746)

3.0 Device Intended 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 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 (TI), spinspin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

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4.0 Device Description

4.1 Function

4.2 Scientific Concepts

Magnetic Resonance Imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. 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.

A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.

4.3 Physical and Performance Characteristics

MRI is currently of great interest because it is capable of producing high quality anatomical images without the associated risks of ionizing radiation. The biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In MR imaging, difference in proton density, blood flow, and TI and T2 relaxation times can all contribute to image contrast. By varying the pulse sequence characteristics, the resulting images can emphasize T1, T2, proton density, or the molecular diffusion of water or other proton containing molecules.

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5.0 Device Technological Characteristics

The technological characteristics of this device are similar to the primary predicate device. The primary difference is the inclusion of software enhancements. The control and image processing hardware and the base elements of the operating system software are identical to the primary predicate device.

6.0 Conclusions

It is the opinion of Hitachi Medical Systems America that ALTAIRE MRI system is substantially equivalent to the listed predicate device. The intended use is identical to the listed predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is facing left and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the upper portion of the circle.

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Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Mr. Doug Thistlewaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087-2371

. Re: K022390

Trade/Device Name: Hitachi ALTAIRE™ Magnetic Resonance Imaging Device Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device . . Regulatory Class: II

Product Code: 90 LNH Dated: July 19, 2002 Received: July 23, 2002

Dear Mr. Thistlewaite:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on 1 your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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762 2390

510(k) Number (if kr Altaire MRDD, w/V4.5 Operating System Software Device Name:

Indications for Use:

Anatomical Region: Nucleus excited: Diagnostic uses:

Head, Body, Spine, Extremities Proton T1, T2, proton density weighted imaging Diffusion weighted imaging MR Angiography Image processing

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEFDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use

David A. Gyson

(Division Sign-Off) Division of Reproductive, A and Radiological Device 510(k) Number

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.