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 Operating System Software is revised to Version 3.7 to increase the clinical utility of the AIRIS in the stationary configuration. The MRP-7000 Operating System Software is revised to Version 3.7 to increase the clinical utility of the MRP-7000 in both stationary and mobile configurations.

Version 3.7 Operating System revisions include the addition of Dynamic Scan measurement and analysis, MTC (magnetization transfer contrast) and SSP (sloped slab profile) for 3D TOF MRA, additional 2D TOF, 2D, and 3D SARGE sequences (steadystate acquisition with gradient rephasing), increased SE and FSE Flip Angle range to 60° - 120°, addition of Fast IR and High Resolution / High Definition Fast IR image acquisition software, addition of High Resolution / High Definition FSE, three additional adaptive filter image post-processing techniques, and Receiver Coil sensitivity correction image post-processing.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The provided 510(k) summary for the Hitachi Medical Systems America Version 3.7 Operating System Software does not contain the information requested in your prompt regarding acceptance criteria and performance study details.

This 510(k) submission is primarily about software updates to an existing Magnetic Resonance (MR) imaging system, not a new diagnostic device that would require extensive clinical performance studies with specific statistical acceptance criteria for diagnostic accuracy.

Here's why the information is missing and what the document does describe:

Focus: The document describes revisions to existing operating system software (Version 3.7) to "increase the clinical utility" of the AIRIS and MRP-7000 MR systems. These revisions include adding new imaging sequences, post-processing techniques, and expanding existing functionalities.
Predicate Device: The document explicitly states the "DEVICE TECHNOLOGICAL CHARACTERISTICS: 5.0 Identical to the Predicate Device." This is a key aspect of 510(k) submissions, where substantial equivalence to a legally marketed device is demonstrated. For software updates to an existing MR system that primarily enhance imaging capabilities rather than introduce new diagnostic claims, a direct comparison to a predicate device's performance in terms of clinical accuracy might not be required in the same way as for a novel diagnostic algorithm.
"Acceptance Criteria" and "Study": When a new diagnostic device or algorithm is submitted, it typically has specific performance metrics (e.g., sensitivity, specificity, AUC) and predefined acceptance criteria (e.g., "sensitivity must be at least X% with a 95% confidence interval") that are then validated through a clinical study. The provided document does not mention any such acceptance criteria or a study designed to prove new diagnostic performance targets.
"Device Performance": The document lists features and capabilities (e.g., "Dynamic Scan measurement and analysis," "MTC (magnetization transfer contrast)," "additional 2D TOF, 2D, and 3D SARGE sequences"). These are descriptions of technical capabilities and imaging modalities, not measured diagnostic performance metrics like accuracy or error rates.

Therefore, I cannot populate the table or answer most of your questions based on the provided text.

Here's what I can extract, noting the absence of most requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not applicable/Not stated in document)	Reported Device Performance (Capabilities/Features)
(Not stated)	Addition of Dynamic Scan measurement and analysis
(Not stated)	Addition of MTC (magnetization transfer contrast)
(Not stated)	Addition of SSP (sloped slab profile) for 3D TOF MRA
(Not stated)	Additional 2D TOF, 2D, and 3D SARGE sequences
(Not stated)	Increased SE and FSE Flip Angle range to 60° - 120°
(Not stated)	Addition of Fast IR and High Resolution / High Definition Fast IR image acquisition software
(Not stated)	Addition of High Resolution / High Definition FSE
(Not stated)	Three additional adaptive filter image post-processing techniques
(Not stated)	Receiver Coil sensitivity correction image post-processing
(Not stated)	Imaging capabilities: 2D, 3D Spin Echo (SE), 2D Fast Spin Echo (FSE), 2D Inversion Recovery (IR), 2D Fast Inversion Recovery (FIR), 2D, 3D Gradient Echo (GE), 2D, 3D Gradient Echo with Rephasing (GR), 2D, 3D Steady state acquisition with rewinded GE (SARGE), 2D Dual Slice acquisition (DS), MR Angiography (2D TOF, 3D TOF, MTC, SSP, half echo, high resolution/high definition)

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

Not explicitly stated. The document describes software updates and enhanced imaging capabilities, implying that the demonstration of these capabilities would likely involve internal testing and possibly images acquired for technical validation rather than a clinical "test set" for diagnostic performance. No information on data provenance (country, retrospective/prospective) is provided.

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

Not applicable/Not stated. No clinical study for diagnostic performance is described, so no ground truth establishment by experts is mentioned.

4. Adjudication method for the test set:

Not applicable/Not stated. No clinical study is described.

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. The device is an MR system's operating software, not an AI diagnostic algorithm. No MRMC study is mentioned.

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

Not applicable. This submission is for MRI operating software providing imaging capabilities, not a standalone diagnostic algorithm.

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

Not applicable/Not stated. No clinical study for diagnostic performance requiring ground truth is described.

8. The sample size for the training set:

Not applicable/Not stated. The document describes software development and enhancement for an MR imaging system. There's no mention of a "training set" in the context of an AI/ML algorithm requiring such data.

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

Not applicable/Not stated. As no training set is mentioned, no ground truth establishment process is described.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence and describing technical enhancements to an existing MR imaging system's operating software. It does not contain the kind of detailed clinical study performance data (acceptance criteria, test sets, ground truth, expert review, etc.) that would be expected for a novel diagnostic device or AI algorithm with specific diagnostic claims.

Summary

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

510(K) SUMMARY

K960181

SUBMITTER INFORMATION: 1.0

Hitachi Medical Systems America 1.1 Submitter: 1963 Case Parkway Twinsburg, OH 44087 PH: 216 425-1313 FX: 216 425-1410
James Jochen Rogers 1.2 Contact:
January 11, 1996 1.3 Date:

DEVICE NAME: 2.8

Magnetic Resonance Diagnostic Device 2.1
System, Nuclear Magnetic Resonance Imaging 2.2 Classification Name:
90LNH 2.3 Classification Number:
Version 3.7 Operating System Software 2.4 Trade/Proprietary Name:
2.5 PREDICATE DEVICE(s):

Hitachi AIRIS with Version 3.4C Operating System Software Hitachi MRP-7000 with Version 3.3B Operating System Software

DEVICE DESCRIPTION: 3.0

3.1 FUNCTION
The AIRIS Operating System Software is revised to Version 3.7 to increase the clinical utility of the AIRIS in the stationary configuration. The MRP-7000 Operating System Software is revised to Version 3.7 to increase the clinical utility of the MRP-7000 in both stationary and mobile configurations.

For previous FDA 510(k) submissions, option software such as Fast Spin Echo, 2D and 3D TOF MRA, and Dual Slice, and option software enhancements [modifications requiring the submission of a 510(k) pre-market notification), have traditionally been documented through separate FDA 510(k) pre-market notification submissions; (Cf. K905834, K920441A, K925009, K926397, K934485, K935664, K935671). For the purposes of simplification, current enhancements to option software which would otherwise be documented through separate 510(k) submissions will also be included as part of this 510(k) submission.

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

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 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 71 and T2 all may contribute to image contrast. In addition, by varving 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:

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

Head, Body, Spine, Extremities Anatomical Region:
Nucleus excited: Proton .
2D T1- / T2-weighted imaging Diagnostic uses: C T1, T2, proton density measurements
- MR Angiography
  - image processing
2D, 3D Spin Echo (SE) Imaging capabilities: .
- 2D Fast Spin Echo (FSE) 2D Inversion Recovery (IR)
- 2D Fast Inversion Recovery (FIR)
- 2D, 3D Gradient Echo (GE)
- 2D, 3D Gradient Echo with Rephasing (GR)
- 2D, 3D Steady state acquisition with rewinded GE (SARGE)
- 2D Dual Slice acquisition (DS)
- MR Angiography (2D TOF, 3D TOF, MTC, SSP, half echo, high resolution/high definition)

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.