(89 days)
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
The subject devices, MAGNETOM Avanto® and MAGNETOM Skyra™ with software syngo MR XA61A, consist of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Sola with syngo MR XA51A (K221733) and MAGNETOM Vida with syngo MR XA50A (K213693).
The provided text is a 510(k) summary for MRI devices (MAGNETOM Avanto fit; MAGNETOM Skyra fit) and does not contain detailed acceptance criteria or a study proving that a specific device meets those criteria in the typical sense for an AI/ML medical device.
This document describes hardware and software updates to existing MR systems, which are general Magnetic Resonance Diagnostic Devices (MRDD). The "acceptance criteria" here are mainly related to maintaining substantial equivalence to predicate devices and conforming to recognized standards for safety and performance (e.g., IEC 60601-1, ISO 14971, NEMA standards for SNR and uniformity, and software validation guidance).
Here's a breakdown based on the information provided, highlighting why it doesn't fit the typical AI/ML device study request:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of specific quantitative performance metrics for a diagnostic task (like sensitivity/specificity for disease detection), the acceptance criteria for these MR systems are based on demonstrating that new and modified components maintain safety and performance comparable to their predicate devices and adhere to relevant standards.
| Acceptance Criteria Type | Reported Device Performance/Evidence |
|---|---|
| Software Validation & Verification | New or modified software features underwent verification and validation, following "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The conclusion is that differences have been tested, and data suggests an equivalent safety and performance profile. |
| Image Quality Assessment | Sample clinical images were used to assess image quality for new/modified pulse sequence types and coils. Comparison images were made between new/modified features and predicate device features. The conclusion is that differences have been tested, and data suggests an equivalent safety and performance profile. |
| Safety and Essential Performance (General) | Conformance to ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 (Medical electrical equipment - general requirements for basic safety and essential performance). |
| Electromagnetic Compatibility | Conformance to IEC 60601-1-2 Edition 4.0:2014-02 (Electromagnetic disturbances - Requirements and tests). |
| Specific MR Equipment Requirements | Conformance to IEC 60601-2-33 Ed. 3.2 b:2015 (Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis). |
| Risk Management | Risk analysis in compliance with ISO 14971 (Medical devices - Application of risk management to medical devices) was performed, identifying and mitigating potential hazards. Siemens Healthcare GmbH adheres to recognized industry standards (e.g., IEC 60601-1 series) to minimize electrical and mechanical hazards. |
| Usability Engineering | Conformance to 62366-1:2015 (Medical devices - Part 1: Application of usability engineering to medical devices). |
| Software Life Cycle Processes | Conformance to IEC 62304 Edition 1.1 2015-06 (Medical device software - Software life cycle processes). |
| SNR and Image Uniformity (Coils) | Performance bench tests were conducted for new coils (Flex Loop Large, UltraFlex Large 18, UltraFlex Small 18, Contour 24) to measure SNR and image uniformity. This followed NEMA MS 6-2008 (R2014) (Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging). Also, heating measurements for coils. |
| Digital Imaging and Communications in Medicine (DICOM) | Conformance to NEMA PS 3.1 - 3.20 (2021e) (Digital Imaging and Communications in Medicine (DICOM) Set). |
| Biocompatibility | Conformance to ISO 10993-1 Fifth edition 2018-08 (Biological evaluation of medical devices - part 1: evaluation and testing within a risk management process). |
| Specific New Features | A "Physiologging Verification Report" was generated for the new "Physiologging" feature, indicating its verification upon introduction. |
2. Sample size used for the test set and the data provenance
The document mentions "sample clinical images" were used for image quality assessment. However, it does not specify the sample size, country of origin, or whether the data was retrospective or prospective.
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. The document states that the devices are intended for use by "healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images," and the images are "interpreted by a trained physician" to assist in diagnosis, but it does not detail an expert ground truth establishment process for a specific test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 such study was mentioned. This submission is for an MR system, not an AI/ML-assisted diagnostic device, so a comparative effectiveness study of human readers with/without AI assistance would not be applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI/ML algorithm-only device; it's a general MR system. Therefore, a standalone algorithm performance study is not applicable or mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device (an MR system), the "ground truth" for image quality assessment would typically be visual comparison by trained MR physicists or radiologists, ensuring that the new sequences or hardware components produce images of diagnostic quality, comparable to, or better than, existing methods. However, the exact type of ground truth (e.g., specific metrics, qualitative expert assessment) is not explicitly stated beyond "image quality assessment by sample clinical images."
8. The sample size for the training set
This information is not applicable. The document describes updates to an MR system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no mention of a training set for a machine learning algorithm.
§ 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.