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510(k) Data Aggregation
(78 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 STRATIS / MRH-1500 Operating System Software is 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 details a 510(k) premarket notification for a modification to a Magnetic Resonance (MR) diagnostic device. The primary change is an increase in 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 document does not detail a study involving human or animal subjects that would typically have acceptance criteria for device performance in a diagnostic context (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" here refer to compliance with safety standards for SAR levels.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Safety Standard) | Reported Device Performance (SAR Limit) |
|---|---|
| FDA Guidance (prior to IEC adoption): < 0.4 W/kg whole body OR demonstrate core temperature increase < 1°C and localized heating < 38°C (head), < 39°C (trunk), < 40°C (extremities) | 0.4 W/kg (original limit) |
| IEC 601-2-33 Standard (Normal Operating Mode, favorable environmental conditions) | Up to 1.5 W/kg |
| IEC 601-2-33 Standard (Normal Operating Mode, derated for environmental conditions due to lack of sensors) | 1.0 W/kg (proposed new limit) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study evaluating diagnostic performance on a dataset of patient scans. It is a modification of a technical safety parameter based on compliance with an international standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" here is the safety standard defined by the IEC, which is established through a consensus process involving experts in medical physics, engineering, and medical safety from various countries. The document does not specify the number or specific qualifications of the experts involved in establishing the IEC standard itself.
4. Adjudication Method for the Test Set
Not applicable. There is no test set of cases requiring adjudication. The change is based on adherence to a recognized international safety standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission focuses on a technical safety parameter (SAR limit) change, not on the diagnostic performance or reader effectiveness with the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device itself (an MRI system) is a standalone imaging device, but this submission is about a change to its operating parameters, not about a new algorithm or AI performance.
7. The Type of Ground Truth Used
The "ground truth" for this submission is an international safety standard for medical electrical equipment (IEC 601-2-33), which defines acceptable levels of Specific Absorption Rate (SAR) for patient safety during MR imaging.
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is not an AI-based or diagnostic performance study.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set. The "ground truth" (IEC standard) was established through a multi-national, multi-disciplinary consensus process among experts in relevant fields (e.g., medical physics, engineering, clinical specialties) to ensure patient safety and device functionality.
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