(57 days)
The MAGNETOM Aera with syngo MR D13E 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 Aera 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 MAGNETOM Aera is a 1.5T, utilizing a superconducting magnet design. The open bore, whole body scanner is designed for increased patient comfort The MAGNETOM Aera is being modified to include another configuration to the MAGNETOM portfolio to be available for Ex-factory (new) systems. The full modifications for the new MAGNETOM Aera configuration include 24 receive channels, modified Measurement and Reconstruction System (MaRS) and Syngo Acquisition Workplace (MRAWP)/Syngo MR Workplace(MRWP), an update to the software syngo MR D13E and the addition of three new coils to the existing MAGNETOM Aera Magnetic Resonance System.
This is a 510(k) summary for a Siemens MAGNETOM Aera 1.5T System, which is a magnetic resonance diagnostic device. The documentation provided does not include specific acceptance criteria or performance study data as would typically be found in a medical device submission for a new or significantly modified device.
The submission is a Special 510(k), indicating that it is for a modification to a previously cleared device (MAGNETOM Aera with syngo MR D13A, K121434). In such cases, the primary goal is often to demonstrate substantial equivalence to the predicate device, rather than to conduct new clinical performance studies with detailed acceptance criteria.
The document states:
- "The MAGNETOM Aera with syngo MR D13E 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."
- "The MAGNETOM Aera with software syngo MR D13E conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety..."
Without specific performance study data, it is not possible to fill out the table or answer most of the questions. However, based on the nature of the submission and the provided text:
1. A table of acceptance criteria and the reported device performance:
No specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy for a particular diagnostic task) are provided in the document. The device is a diagnostic imaging system, and its performance is generally evaluated against its ability to acquire high-quality images and spectra, and this submission focuses on demonstrating that the modified system maintains performance equivalent to the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
No information about a specific test set or data provenance is provided. Given that this is a Special 510(k) for a modification to an existing MRI system, the primary argument for substantial equivalence likely relies on technical specifications, verification and validation testing (e.g., image quality phantoms, electrical safety, software testing), and comparison to the predicate device's established performance, rather than a new clinical study with a specific patient test set.
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):
Not applicable, as no clinical test set or ground truth establishment by experts is described in this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set or adjudication process is described in this 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:
Not applicable. This document describes an MRI hardware and software upgrade, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is an MRI system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical study requiring ground truth is described. The "ground truth" for an MRI system's performance would primarily be related to its physical and image quality metrics (e.g., signal-to-noise ratio, spatial resolution, contrast, artifact levels), which are typically assessed using phantoms and technical specifications.
8. The sample size for the training set:
Not applicable. This document is for an MRI system, not an AI model requiring a training set in the conventional sense. The "training" for such a system would involve engineering and development, not data-driven machine learning model training.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set mentioned or implied for an AI model.
§ 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.