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510(k) Data Aggregation
(87 days)
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.
The AIRIS Operating System Software is revised to Version 4 to increase the clinical utility of the AIRIS in the stationary configuration. The MRP-7000 Operating System Software is revised to Version 4 to increase the clinical utility of the MRP-7000 in both stationary and mobile configurations.
Version 4 Operating System revisions include automatic per patient RF Gain calibration for improved fat suppression, daily- or per-patient x- y- and z-axis gradient offsets for regional shimming, MR cholangiography sequences (MRCP) for improved imaging of the biliary tract, Fluoroscopic MR imaging sequences for 'nearreal-time' imaging, FLAIR (fast low-angle inversion recovery) sequence for suppression of CSF signal, segmented K-space SARGE sequence for time-improved cardiac imaging, addition of rephasing to several FSE sequences, addition of RS (RF Spoiled) SARGE sequence, improved method for body return artifact rejection, submillimeter slice thickness for 3DTOFMRA sequences, reduced slice interval for 3D TOF/GE/SARGE/SE acquisitions, high-definition imaging by 512 matrix reconstruction, short TE SE sequences (TE=9, 10ms), addition of rephasing to 3D SARGE sequence, 'whole echo' 3DTOFMRA, non-linear window for MRA, brightness normalization for selected images with the same acquisition parameters within a patient study, and ACR/NEMA/DICOM 3 support.
In addition, the MRP-7000 and AIRIS Operating System Software are modified to change the maximum SAR limit from 0.4 W/kg to 1.0 W/kg as permitted under the International Electrotechnical Commission (IEC) standard Part 2: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis.
This document describes the 510(k) premarket notification for the Hitachi Version 4 Operating System Software for AIRIS and MRP-7000 MRI devices. The primary focus of the submission is to increase the maximum Specific Absorption Rate (SAR) limit from 0.4 W/kg to 1.0 W/kg, aligning with the International Electrotechnical Commission (IEC) standard Part 2: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis. The submission also details various software revisions to enhance clinical utility.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly defined in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) for the imaging capabilities. Instead, the primary "acceptance criterion" addressed in this 510(k) is the compliance with a higher SAR limit based on an internationally recognized safety standard. The device's "performance" in this context refers to its ability to operate safely at the higher SAR level.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: Compliance with IEC-601-2-33 standard for SAR, specifically permitting a maximum SAR of 1.0 W/kg for the general patient population, derated from 1.5 W/kg due to absence of bore temperature/humidity sensors to 1.0 W/kg. | Hitachi proposes limiting SAR control for MRP-7000 and AIRIS MRI systems to a maximum of 1.0 W/kg, up from the previous 0.4 W/kg limit, to comply with the NORMAL OPERATING MODE defined in the IEC standard. The devices were originally cleared at 0.4 W/kg and this change leverages the new international safety standard. |
| Functional Equivalence: The software revisions maintain or improve the clinical utility of the device and do not introduce new safety concerns compared to the predicate device. | The Version 4 Operating System software includes numerous revisions to increase clinical utility (e.g., improved fat suppression, new imaging sequences like MRCP, FLAIR, SARGE, high-definition imaging, ACR/NEMA/DICOM 3 support). The device's technological characteristics are stated as "Identical to the Predicate Device" in Section 5.0, implying that the fundamental imaging principles and intended use remain the same, with enhancements rather than fundamental changes impacting safety or effectiveness. |
| Intended Use: The device continues to meet the intended use for MR systems as an imaging device to provide physiological and clinical information by displaying internal structures of the head, body, and extremities, based on proton density, T1, T2, and flow. | The stated "Indications for Use" (Section 6.0) are identical to those in Section 4.0, which describe the standard intended use of an MR system, including anatomical regions, excited nucleus, diagnostic uses (2D T1/T2-weighted imaging, T1/T2/proton density measurements, MR Angiography, image processing), and imaging capabilities. This remains consistent with the predicate. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a specific test set or clinical study with a defined sample size for evaluating the Version 4 Operating System Software or the change in SAR limit.
The data provenance for the SAR limit change is based on the International Electrotechnical Commission (IEC) standard IEC-601-2-33. The submission references an existing international standard and the FDA's supposed acceptance of its provisions, rather than presenting new clinical or performance data from a specific study.
For the new software features, the document states they "increase the clinical utility" and are revisions to existing systems. There is no mention of specific sample sizes or data provenance for proving the efficacy or performance of these new features. It's implied that these are incremental improvements to an already cleared device, not requiring new clinical performance studies for their functionality.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. As there is no described test set or clinical study to evaluate the device's diagnostic performance for which ground truth would need to be established, this detail is absent. The submission primarily focuses on safety compliance (SAR limit) and functional enhancements to an existing device rather than diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable as no specific test set requiring adjudication is described in the document.
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
This information is not applicable and no such study was performed or is mentioned. The device in question is an MRI system's operating software, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is an MRI system's operating software, which requires human operation and interpretation. It is not an algorithm that would typically be evaluated in a standalone performance study in the context of diagnostic accuracy. The "algorithm-only" aspect mentioned refers to the safety calculation for SAR, which is part of the system's inherent design and safety features, not a diagnostic algorithm.
7. The Type of Ground Truth Used
For the primary claim concerning the SAR limit increase, the "ground truth" used is the IEC-601-2-33 standard itself, which defines the safety parameters and acceptable SAR levels. This is a consensus-based international safety standard, rather than clinical outcomes or pathology data.
For the other software features, no specific ground truth is mentioned, as no formal performance testing in the conventional sense (e.g., against pathology) is described for these enhancements. The improvements in "clinical utility" would likely be assessed through engineering verification and validation against design specifications and potentially internal clinical evaluations, but not a large-scale ground truth study.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The document describes an update to an MRI system's operating software and a change in its SAR limit. This is not a machine learning or AI-driven device that requires a training set in the typical sense for image interpretation or diagnosis.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as no training set for a machine learning model is described.
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