(25 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.
MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system includes new hardware compared to the predicate device, MAGNETOM Viato.Mobile with software syngo MR XA51A and XJ gradient system. A highlevel summary of the modified hardware is provided below:
Hardware
Modified Hardware
- Gradient Coil
- Gradient Power Amplifier
This document is a 510(k) summary for the MAGNETOM Viato.Mobile system from Siemens Medical Solutions USA, Inc. The submission is for a modification to an already cleared device, primarily involving new hardware (Gradient Coil and Gradient Power Amplifier) and an XQ gradient system option. This is a claim of substantial equivalence to an existing predicate device, not a new device requiring a full de novo study. Therefore, the information provided focuses on demonstrating that the modified device performs as safely and effectively as the predicate, rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical context.
Here's an analysis based on the provided text, addressing your questions where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for diagnostic performance or a direct "reported device performance" in terms of clinical outcomes. Instead, it focuses on demonstrating that the modified hardware maintains the same safety and performance profile as the predicate device and reference device. The acceptance is based on compliance with standards and non-clinical testing.
| Performance Test / Acceptance Criteria | Reported Device Performance |
|---|---|
| Nonclinical Tests: | |
| Performance bench test | "performs as intended" |
| Verification and validation | "performs as intended" |
| Electrical safety and EMC (IEC 60601-1-2) | "performs as intended" |
| ISO 14971 (Risk Management) | "ensured via a risk analysis" |
| IEC 60601-1 series (Electrical/Mechanical Hazards) | "minimizes electrical and mechanical hazards" |
| IEC 60601-2-33 (MR equipment safety) | Device conforms |
| NEMA MS 4:2010 (Acoustic Noise) | Device conforms |
2. Sample Size for the Test Set and Data Provenance
Since this is a submission for a hardware modification and claims substantial equivalence based on non-clinical testing and comparison to a predicate, there is no "test set" in the traditional sense of a patient cohort or imaging dataset used to assess diagnostic performance. The testing involved new hardware itself.
- Sample Size for Test Set: Not applicable in a clinical diagnostic performance sense. Non-clinical hardware tests were performed.
- Data Provenance: Not applicable for diagnostic performance.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The ground truth for this submission concerns the performance and safety of the hardware modification, established through engineering tests and compliance with recognized standards. There were no experts establishing ground truth for diagnostic interpretations for this specific submission.
4. Adjudication Method
- Adjudication Method: Not applicable. There was no clinical ground truth requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document explicitly states: "No clinical study and no additional clinical tests were conducted to support substantial equivalence for the subject device." This means there was no MRMC study to compare human readers with or without AI assistance, as the device itself is an MR scanner, not an AI-assisted diagnostic tool.
6. Standalone Performance Study
- Standalone Performance Study: No. This submission focuses on hardware safety and performance modifications of an MR scanner, not the standalone diagnostic performance of an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Engineering test results and measurements: For performance bench tests, electrical safety, and electromagnetic compatibility.
- Compliance with recognized international standards: Like IEC 60601 series, ISO 14971, and NEMA MS 4:2010, which define safety and performance requirements for medical electrical equipment and MR systems.
- Comparison to the established safety and performance profile of the predicate and reference devices: The core argument is substantial equivalence, meaning the new hardware does not introduce new questions of safety or effectiveness compared to legally marketed devices.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI-driven image analysis algorithm that requires a training set of images. It is a hardware modification to an MR scanner.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI algorithm in this submission.
§ 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.