(72 days)
Your MAGNETOM system is indicated for use as a magnetic 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 inages 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.
Your 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 Avanto Fit with software syngo MR XA50A includes new and modified hardware and software compared to the predicate device. MAGNETOM Sola with software syngo MR XA31A. A high level summary of the new and modified hardware and software is provided below:
Hardware
Modified Hardware
- Cover: The cover has been modified to bring the system up to the Siemens Healthineers Design incl. all BioMatrix components and interfaces.
- EPC (Electronic Cabinet and Measurement Control / Electronic Power Cabinet): upgrade of components to upgrade the EPC to the newest electronic cabinet series
Software
New Features and Applications
- TSE MoCo: TSE MoCo is an image-based motion correction in the averagedimension for the TSE pulse sequence type.
- Automatic fiducial detection: MR Breast Biopsy is improved with an automatic fiducial detection.
- AbsoluteShim: The AbsoluteShim mode is a shimming procedure based on a 3-echo gradient echo protocol.
Modified Features and Applications
- Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types.
Other Modifications and / or Minor Changes - The MAGNETOM Avanto Fit is a new MRI System which is the result of an upgrade from a MAGNETOM Avanto
This document describes the regulatory clearance for the Siemens MAGNETOM Avanto Fit, a Magnetic Resonance Diagnostic Device (MRDD). The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device. This type of submission generally does not require extensive clinical studies or acceptance criteria tables with numerical thresholds, as the focus is on demonstrating that the new device is as safe and effective as an existing one, not necessarily proving novel clinical performance beyond the predicate.
Therefore, the requested information on "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size," "number of experts," "adjudication method," "MRMC study," "standalone performance," and "ground truth" (as typically defined for AI/CADe device submissions) is not applicable to this 510(k) submission for a conventional MRDD.
This submission focuses on demonstrating that modifications and new features (TSE MoCo, Automatic fiducial detection, AbsoluteShim, Fast GRE RefScan) on the MAGNETOM Avanto Fit do not change its fundamental safety or effectiveness compared to the predicate MAGNETOM Sola.
Here's an explanation based on the provided text, addressing why most of the requested points are not present:
1. A table of acceptance criteria and the reported device performance:
- Not applicable in this context. For a 510(k) of a conventional MRDD, "acceptance criteria" are generally met by demonstrating compliance with recognized standards and showing that changes do not introduce new safety concerns or degrade performance compared to the predicate. There isn't a specific performance metric table with numerical targets as would be seen for, say, an AI-driven diagnostic algorithm with a quantifiable output like sensitivity/specificity for a particular disease.
- The performance demonstration implicitly relies on:
- Image quality assessments: "Image quality assessments by sample clinical images. In some cases a comparison of the image quality / quantitative data was made."
- Performance bench tests: For new/modified hardware.
- Software verification and validation: Ensuring new software features function as intended and meet design specifications.
- Safety tests: Electrical, mechanical, structural, and related system safety tests (compliance with AAMI / ANSI ES60601-1, IEC 60601-2-33).
2. Sample size used for the test set and the data provenance:
- Not explicitly stated for a dedicated "test set" in the context of clinical performance evaluation. The document mentions "sample clinical images" were used for image quality assessments. These are likely images acquired during internal testing or from a small cohort, but not a large, controlled, prospective dataset for a formal clinical trial of diagnostic accuracy.
- Data Provenance: Not specified, but generally, such internal testing images would be from Siemens' development or internal research facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/specified. As no formal clinical trial with an established "ground truth" (e.g., pathology-confirmed diagnosis for a specific disease) was conducted or needed, expert reads for ground truth establishment are not detailed. Image quality assessments would be done by qualified internal personnel, but this isn't the same as clinical ground truth.
4. Adjudication method for the test set:
- Not applicable/specified. No formal adjudication process is described because a clinical diagnostic performance study requiring expert consensus for ground truth was not performed.
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 device is a Magnetic Resonance Diagnostic Device (MRDD), not an AI-assisted diagnostic software. It produces images and spectra that are then interpreted by a trained physician. The new features mentioned (TSE MoCo, Automatic fiducial detection, AbsoluteShim, Fast GRE RefScan) are technical improvements to image acquisition and processing, not AI algorithms intended to directly assist or influence human reader performance in a diagnostic task that would typically be evaluated with an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to a medical imaging device itself, not a separate standalone algorithm.
7. The type of ground truth used:
- Not explicitly defined as a "ground truth" dataset in the clinical sense. For MRDDs, performance is often assessed against engineering specifications, phantom measurements, and the visual quality of clinical images, rather than against a disease-specific "ground truth" (like biopsy results for a target lesion). The "ground truth" for showing substantial equivalence relies on demonstrating that the output (MR images) remains clinically acceptable and safe.
8. The sample size for the training set:
- Not applicable. This device is an MR scanner with modified hardware and software for image acquisition and reconstruction, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary of Device Performance (Based on the document):
The document states:
- "The results from each set of tests demonstrate that the subject device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared."
- "While there are some differences in technical features compared to the predicate device, the differences have been tested and the conclusions from all verification and validation data suggest that the features bear an equivalent safety and performance profile to that of the predicate device and reference devices."
Key tests performed (Nonclinical Tests Section 9):
- Sample clinical images (for image quality assessments)
- Performance bench tests (for new/modified hardware)
- Software verification and validation (for new/modified software features)
- Electrical, mechanical, structural, and related system safety tests (compliance with AAMI / ANSI ES60601-1, IEC 60601-2-33)
In conclusion, this 510(k) submission for a conventional Magnetic Resonance Diagnostic Device (MRDD) primarily relies on non-clinical engineering, software, and image quality testing to demonstrate substantial equivalence, rather than extensive clinical performance studies with specific patient "ground truth" evaluations as would be required for novel AI/CADe devices.
§ 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.