(73 days)
Your 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 inages 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.
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 Skyra Fit with software syngo MR XA50A includes new and modified hardware and software compared to the predicate device, MAGNETOM Vida 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.
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 Skyra Fit is a new MRI System which is the result of an upgrade from a MAGNETOM Verio.
The provided document is a 510(k) summary for the MAGNETOM Skyra Fit device, which is a Magnetic Resonance Diagnostic Device (MRDD). This document primarily focuses on establishing substantial equivalence to a predicate device (MAGNETOM Vida) and does not detail a clinical study with acceptance criteria, human reader performance, or training/test set specifics for an AI algorithm.
The document states:
- "No additional clinical tests were conducted to support substantial equivalence for the subject device; however, as stated above, sample clinical images were provided. No clinical publications were referenced." (Page 6, Section 10. Clinical Tests / Publications)
- The performance tests conducted were "Sample clinical images" and "Image quality assessments by sample clinical images." (Page 6, Section 9. Nonclinical Tests)
Therefore, based on the provided text, a detailed answer to your request, particularly concerning acceptance criteria for an AI device, human reader studies, and AI training/test set specifics, cannot be fully provided directly from this document. This document describes a new MR system, not an AI software.
However, I can extract the information that is present and explain where the requested information is not available:
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A table of acceptance criteria and the reported device performance
- Not explicitly provided in terms of numerical acceptance criteria for a clinical study comparing performance against a predicate. 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." (Page 6, Section 9. Nonclinical Tests). The performance assessment appears to be qualitative based on "sample clinical images" and "image quality assessments."
- Device Performance (as described): "The subject device performs as intended and is thus substantially equivalent to the predicate device." (Page 6)
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided. The document mentions "sample clinical images" but does not specify the sample size, data provenance, or whether they were retrospective or prospective.
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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 provided. The document refers to images interpreted by a "trained physician" for diagnosis (Page 5, Section 5. Intended Use), but this is a general statement about the use of an MRDD, not specific to establishing ground truth for a test set in the context of a new feature evaluation or AI study.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not provided.
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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 study was done. The document explicitly states, "No additional clinical tests were conducted to support substantial equivalence for the subject device..." (Page 6).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not done for an AI algorithm. This document is for an MR imaging system, not an AI diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated/not applicable in the context of an AI study. The "sample clinical images" were likely evaluated for image quality and equivalence to the predicate, rather than for diagnostic ground truth for an AI algorithm.
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The sample size for the training set
- Not applicable/Not provided. This is not a submission for an AI algorithm that would require a distinct training set.
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How the ground truth for the training set was established
- Not applicable/Not provided.
Summary based on the provided document:
This 510(k) submission for the MAGNETOM Skyra Fit MRI system focuses on demonstrating substantial equivalence to a previously cleared predicate device (MAGNETOM Vida) by showing that new and modified hardware and software features maintain equivalent safety and performance. This is typically achieved through non-clinical performance testing, including image quality assessments, software verification and validation, and electrical/mechanical safety tests, rather than multi-reader clinical studies or AI algorithm performance evaluations.
The "sample clinical images" mentioned are likely used to qualitatively demonstrate that the new system's output images are comparable in quality to those of the predicate device, thereby supporting the claim of substantial equivalence for diagnosis when interpreted by a trained physician. The document explicitly states that no additional clinical tests were conducted, meaning there were no new studies involving human readers or comparative effectiveness with or without AI assistance.
§ 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.