(52 days)
The MAGNETOM systems Aera and Skyra with the updated software syngo MR DI3A 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, vield information that may assist in diagnosis.
The MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A 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 version syngo MR D13A is updated for two Siemens MR systems:
- o MAGNETOM Aera (1.5T)
- o MAGNETOM Skyra (3T)
Systems that are already in clinical use and at customer sites can be updated with this software update; both MAGNETOM systems can be manufactured with this software update.
This software update includes modified software sequences for MAGNETOM Aera and MAGNETOM Skyra.
MAGNETOM Aera and MAGNETOM Skyra with software syngo MR D13A were previously cleared under K121434 (November 5, 2012).
Summary of Features New with the Software Update compared to the commercially available Software Version syngo MR D13A:
Software
- Modified sequences: .
- Quiet sequences o
- VIBE sequence improvements o
The provided text describes a 510(k) submission for a software update to already cleared MRI systems (MAGNETOM Aera and MAGNETOM Skyra). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing extensive de novo clinical trials with specific acceptance criteria in the same way a new device might.
Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the traditional sense, as would be expected for a new AI/CAD device with a specific performance metric, is largely absent or interpreted differently in this context. The "acceptance criteria" here are primarily about demonstrating that the updated software performs as intended and does not raise new issues of safety or effectiveness compared to the predicate device.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a software update for an existing MRI system, the "acceptance criteria" are not reported as specific numerical performance targets (e.g., sensitivity, specificity for a diagnostic task). Instead, the acceptance is based on maintaining the safety and effectiveness of the cleared predicate device while introducing new features.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performs as intended. | "The results from each set of tests demonstrate that the device performs as intended..." (Page 3) |
| No new issues of safety or effectiveness. | "…[the modified sequences] do not introduce any new issues of safety or effectiveness." (Page 4) |
| "Risk Management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards..." (Page 3) | |
| "MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A conform to the applicable FDA recognized and international IEC. ISO and NEMA standards with regards to performance and safety..." (Page 3) | |
| Maintains existing Indications for Use. | "There are no changes to the Indications for Use for the subject device, compared to that of the predicate MAGNETOM scanners with software syngo MR D13A." (Page 3) |
| New features (Quiet sequences, VIBE sequence improvements) function as described and offer benefits without compromising safety/effectiveness. | "…the updated software provides the user with additional capabilities… it has the same technological characteristics as that of the predicate devices. The modifications… make the systems and software more user- and patient-friendly - providing imaging techniques with lower noise towards the patient; improving the user's workflow; providing additional information and options to the user." (Page 4) Specific performance metrics for "lower noise" or "improved workflow" are not quantified in this summary. |
| Compliance with relevant standards. | "MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A conform to the applicable FDA recognized and international IEC. ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document." (Page 3) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as this was not a clinical trial in the traditional sense for diagnostic accuracy. The document mentions "clinical images are provided to support the modified software features" (Page 3), but the number of images or patients (sample size) for this support is not specified.
- Data Provenance: Not specified. Given it's a software update for globally available Siemens MRI systems, the images could be from various regions.
- Retrospective or Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable and not provided. The study did not involve establishing ground truth for diagnostic accuracy in a clinical test set. The images were provided to support the functionality of new features, likely evaluated internally by engineering and clinical applications specialists, but not by independent experts in a ground-truth adjudication process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable and not provided. There was no formal adjudication process by independent experts for a diagnostic test set in this 510(k) submission.
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 MRMC comparative effectiveness study was done. This device is an MRI system software update, not an AI/CAD diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not an AI algorithm. The performance evaluation would have been on the entire MRI system with the updated software, which always involves a human operator and physician interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. As this was not a diagnostic accuracy study for a specific condition, the concept of "ground truth" for a disease state is not central to this submission. The "ground truth" (or verification/validation) for the software features would relate to whether the sequences produce images as designed (e.g., lower noise as intended for "Quiet sequences," VIBE sequence improvements are visually present and functional as per engineering specifications).
8. The sample size for the training set
- Not applicable. This is a software update for an MRI system, not a machine learning or AI-based device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there was no training set for an AI 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.