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 STRATIS / MRH-1500 Operating System Software is revised to Version 6 to increase the clinical utility of the STRATIS / MRH-1500 in the stationary configuration.

Version 6 Operating System revisions include the addition of RF spoiling, SSP for enhanced 3D MRA, RF Fat Suppression, MTC for background suppression, 3D-FSE, 3D-FIR, rephase added to 2D-FSE and 2D-GFF, 2D-FIR Dual Contrast, RF coil uniformity image post-processing, and adaptive image post-processing.

AI/ML Overview

I am sorry, but the provided text does not contain the necessary information to answer your request regarding acceptance criteria and a study proving device performance. The text describes a 510(k) summary for a Magnetic Resonance Diagnostic Device (Version 6 Operating System Software) and focuses on the device's function, scientific concepts, physical/performance characteristics, and intended use as compared to a predicate device.

Specifically, the following information is missing from the provided document:

Acceptance criteria and reported device performance: No specific performance metrics, thresholds, or results are mentioned.
Study details: There is no description of any clinical or technical study, including sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods.
MRMC comparative effectiveness study: No such study is mentioned or details provided.
Standalone algorithm performance: No standalone performance data is presented.
Ground truth type: Not specified for any hypothetical study.
Training set size and ground truth establishment: Not mentioned.

Therefore, I cannot generate the table or the detailed description of the study as requested.

Summary

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*961969

SEP - 5 1996

Attachment 1

510(k) Summary of Safety and Effectiveness

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K961969

1.0 SUBMITTER INFORMATION:

1.1 Submitter: Hitachi Medical Systems Ainerica 1963 Case Parkway Twinsburg, OH 44087 PH: 216 425-1313 FX: 216 425-1410
1.2 James Jochen Rogers Contact:
1.3 Date: May 15, 1996

2.0 DEVICE NAME:

2.1 Magnetic Resonance Diagnostic Device
2.2 Classification Name: System, Nuclear Magnetic Resonance Imaging
2.3 Classification Number: 90LNH
2.4 Trade/Proprietary Name: Version 6 Operating System Software

2.5 PREDICATE DEVICE(s):

Hitachi STRATIS with Version 3 Operating System Software Hitachi MRH-1500 with Version 3 Operating System Software

3.0 DEVICE DESCRIPTION:

FUNCTION 3.1
The STRATIS / MRH-1500 Operating System Software is revised to Version 6 to increase the clinical utility of the STRATIS / MRH-1500 in the stationary configuration.

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 waveleneth 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.

3.3 PHYSICAL AND PERFORMANCE CHARACTERISTICS

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 imaging T1, T2, proton density measurements
- MR Angiography image processing
· Imaging capabilities:

2D, 3D Spin Echo (SE) 2D Short Spin Echo (SES) 2D, 3D Fast Spin Echo (FSE) 2D Inversion Recovery (IR) 2D, 3D Fast Inversion Recovery (FIR) 2D,3D Gradient Field Echo (GFE); also with rephasing 2D, 3D Rapid Scan (RS) MTC, RF Spoiling

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MR Angiography, (2D INFA, 3D INFA, 2D GFEA, 3D GFEA, Sloped Slab Profile (SSP)) RF Coil Uniformity Adaptive Image post-processing

DEVICE TECHNOLOGICAL CHARACTERISTICS: 5.0

Identical to the Predicate Device.

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.