(175 days)
The MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display 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 systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.
The software syngo MR D13A is the latest software version for four Siemens MR scanners: MAGNETOM Aera (1.5T), Skyra (3T), Avanto (1.5T), and Verio (3T). New scanners will be manufactured with this software version; existing scanners can be upgraded to this software version. The new software version includes new software sequences, applications, coils and other hardware for the four MAGNETOM scanners. While some new features (hardware and software) are only available for certain scanners (of the four listed), the basic syngo MR D13A software will run on each of the four MAGNETOM systems.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device, based on the requested information.
It's important to note that the provided text is a 510(k) Summary for a software update to an existing Magnetic Resonance Diagnostic Device (MRDD). The focus of this type of submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing de novo performance for an entirely new device. Therefore, the "acceptance criteria" and "study" described are primarily focused on verification and validation of the new software features and hardware components against established performance expectations for MRDDs, rather than a clinical effectiveness study to prove diagnostic accuracy from scratch.
Acceptance Criteria and Device Performance for Software syngo MR D13A
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Derived) | Reported Device Performance / Assessment |
|---|---|
| Device Performance (Coils) | Tested for SNR, image uniformity, and heating. Results demonstrate performance as intended. |
| Device Performance (Magnet) | Tested for SNR, geometric distortion, image uniformity, and slice profile/thickness/spacing. Results demonstrate performance as intended. |
| MP2RAGE Sequence | Dedicated phantom testing conducted. Results demonstrate performance as intended. |
| MNO Spectroscopy | Performance parameters phantom-tested. Results demonstrate performance as intended. |
| syngo ASL 3D | Tested using a dedicated phantom. Results demonstrate performance as intended. |
| MR Elastography | Tested using a dedicated phantom. Results demonstrate performance as intended. |
| T1 mapping with B1 correction | Phantom-tested. Results demonstrate performance as intended. |
| All Software Features (General) | Verified and validated. Results demonstrate performance as intended. |
| Substantial Equivalence | Demonstrated through comparison to legally marketed predicate devices. No new issues of safety or effectiveness introduced. |
| Safety and Effectiveness | Risk analysis (ISO 14971:2007), adherence to industry standards (IEC 60601-1 series), and conformity to FDA recognized/international standards (IEC, ISO, NEMA) for MR FDA Guidance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of patient or image count. The testing involved various phantom studies.
- Data Provenance: The testing appears to be primarily laboratory-based using phantoms. The document does not specify country of origin for any human data (as "clinical tests" were not conducted to support substantial equivalence). Clinical images were provided "to support the new coils as well as the new and modified software features," suggesting these were likely retrospective images acquired during routine clinical practice or for specific development purposes, but their source and specific sample size are not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document globally refers to "trained physicians" interpreting images and/or spectra as part of the intended use, but this is not about establishing ground truth for the device's technical performance tests. For the nonclinical tests described, the "ground truth" would be established by engineering and physics measurements against design specifications and predicate device performance, not by clinical experts.
4. Adjudication Method for the Test Set
- Not applicable/explicitly stated. The nonclinical tests relied on direct measurements and comparisons to engineering specifications and predicate device performance, not on subjective human adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. The document explicitly states: "There were not any clinical tests conducted to support the subject device and the substantial equivalence argument, however clinical images were provided to support the new coils as well as the new and modified software features of the subject device." This indicates that no MRMC study to assess human reader improvement with or without AI assistance was performed. The device is a software update to an MR scanner, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, in spirit. The described "nonclinical tests" are essentially standalone performance evaluations of the software sequences, hardware components (coils, magnet), and specific applications (MP2RAGE, MNO Spectroscopy, syngo ASL 3D, MR Elastography, T1 mapping). These tests assess the device's technical specifications and capabilities independently of human interpretation of diagnostic findings, ensuring the MR system, with the new software, generates high-quality images and data as intended.
7. The Type of Ground Truth Used
- Technical/Physical Ground Truth: For the nonclinical tests (SNR, image uniformity, geometric distortion, slice profile, heating, etc.), the ground truth was established by objective physical measurements, comparison to established engineering specifications, and performance expected of predicate MR systems. For specific phantom tests, the phantom's known physical properties served as the ground truth.
8. The Sample Size for the Training Set
- Not applicable/explicitly stated. The device is a software update for an MR scanner, not a machine learning or AI algorithm that typically requires a distinct "training set" of data in the same way. The software functionality would have been developed and tested iteratively, but the concept of a "training set" as understood in AI/ML contexts does not directly apply here.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a software update for an MR scanner rather than an AI/ML diagnostic tool, a dedicated "training set" with established ground truth in the typical sense is not used. Software development and verification would involve internal testing against known specifications and desired outcomes during the development cycle.
§ 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.