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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 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.

Your MAGNETOM system 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.

MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit with software syngo MR XA20A includes new and modified hardware and software compared to the predicate device, MAGNETOM Sola with software syngo MR XA11A. A high level summary of the hardware and software is provided below:

Hardware

• Computer
• Nose Marker for Inline Motion Correction
  Coils
• BM Body 18: The new BM Body 18 coil is a receive coil with 18 elements and is based on the Body 18 coil, (cleared with K101347). It is a general purpose coil.
  The BM Body 18 coil can be used with two different cables of different length; this capability was introduced with the BM Body 12 coil.

Software
Features and Applications

• SMS for TSE DIXON: Simultaneous excitation and acquisition of multiple slices with the Simultaneous multi-slice (SMS) technique for TSE Dixon imaging.
• GOLiver is a set of optimized pulse sequence for fast and efficient imaging of the abdomen / liver. It is designed to provide consistent exam slots and to reduce the workload for the user in abdominal / liver MRI.
• Angio TOF with Compressed Sensing (CS): The Compressed Sensing (CS) functionality is now available for TOF MRA within the BEAT pulse sequence type for the 1.5 T MR systems. Scan time can be reduced by an incoherent undersampling of k-space data. The usage of CS as well as the acceleration factor and further options can be freely selected by the user.
• RT Respiratory self-gating for FL3D VIBE: Non-contrast abdominal and thoracic examination in free breathing with reduced blur induced by respiratory motion.
• i SMS for RESOLVE and QDWI: Simultaneous excitation and acquisition of multiple slices with the Simultaneous multi-slice (SMS) technique for readout-segmented echo planar imaging (RESOLVE) and quiet diffusion weighted imaging (QDWI).
• SPACE with Compressed Sensing (CS): The Compressed Sensing (CS) functionality is now available for the SPACE pulse sequence type. Scan time can be reduced by the incoherent under-sampling of the k-space data. The usage of CS as well as the acceleration factor and other options can be freely selected by the user.
• SEMAC: SEMAC is a method for metal artifact correction in ortho imaging of patients with whole joint replacement. Using Compressed Sensing the acquisition can be accelerated.
• TSE MDME: A special variant of the TSE pulse sequence type which acquires several contrasts (with different TI and TE, i.e. Multi Delay Multi Echo) within a single sequence.
• TFL (3D MPRAGE), TSE and GRE with Inline Motion Correction: 3D -MPRAGE, TSE and GRE with Inline Motion Correction: Tracking of motion of the head during head scans with a nose marker and a camera system. The MR system uses the tracking information to compensate for the detected motion.
• EP SEG PHS: pulse sequence type EP SEG PHS, based on BEAT EPI and modified with a silent period that can be used by external devices/applications for synchronization with the MR imaging
• GRE PHS: pulse sequence type GRE PHS, is a GRE pulse sequence type, modified to provide a silent period that can be used by external devices/applications for synchronization with the MR imaging.
• GRE Proj: The GRE projection pulse sequence type "" allows the acquisition of 1-D projection data for different orientations.
• GOKnee2D: GOKnee2D is a set of multi-band pulse sequence types with Simultaneous Multislice TSE for fast and efficient imaging of the knee. It is designed to provide consistent exam slots and to reduce the workload for the user in Knee MRI.
• BEAT_interactive: The BEAT_Interactive pulse sequence type is a modification of the BEAT IRTTT pulse sequence type in order to interactively increase the slice thickness and switch on and off a magnetization pulse that the user can select prior to the measurement start.
• EP2D SE MRE: As an alternative of greMRE, EP2D SE MRE pulse sequence type is based on single-shot EP2D_SE_MRE sequence. It offers acquisition of multiple slices in a single, short breath-hold, and it is more robust against signal dephasing effects while providing comparable relative stiffness values.
• ZOOMit DWI: syngo ZOOMit based on EPI diffusion allows diffusion weighted imaging (DWI) while avoiding signal and artifacts from surrounding tissue. The feature is now available for 1-ch-systems and enables improved robustness to infolding artifacts from tissue from outside the excited reqion.
• SPACE Flair Improvements: SPACE pulse sequence type offers a magnetization preparation mode for brain imaging with FLAIR contrast (FLuid Attenuated Inversion Recovery); improving the image quality of FLAIR images.
• External Phase Correction Scan for EPI Diffusion: Separate N/2 Nyquist ghost correction acquisition method for diffusion imaging in the presence of fat.
• MR Breast Biopsy Workflow improvements: The changes made to MR Breast Biopsy application target two areas: the improved readability of planning results and the ability to handle the planning of multiple biopsy targets.
• GOBrain / GOBrain+: GOBrain (brain examination in short acquisition time) GOBrain+ (adaptation of GOBrain pulse sequences)

Software / Platform

• Dot Cockpit: MR Protocol Manager as part of a scanner fleet with connection via a share.
• Access-i: The interface Access-i allows 3rd party devices to establish a bidirectional communication with the MR scanner via a secure local network connection, supporting data transfer to and triggering of data acquisition from the 3rd party device. It enables the 3rd party client to control and edit a measurement program on the MR.
• Table positioning mode: A new table positioning mode "FIX" is introduced which complements the existing table positioning modes ISO and LOC to support workflows in which the user needs to be in control of a defined Zposition at which measurements get executed.

Other Modifications and / or Minor Changes

• MAGNETOM Sola Fit: The MAGNETOM Sola Fit is a new MRI System which is the result of an upgrade from a MAGNETOM Aera.
• BM Body 12: For MR examinations of head and neck in situations where a rigid rf head coil cannot be used, e.g. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution as what can be achieved with 4-channel Flex rf coils
• Body 18: For MR examinations of head and neck in situations, where a rigid rf head coil cannot be used, e.g. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution than what can be achieved with 4-channel Flex rf coils
• UltraFlex Large 18, UltraFlex Small 18: For MR examinations of head and neck in situations, where a rigid rf head coil cannot be used, e.g. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution than what can be achieved with 4channel Flex rf coils
• Broad band / narrow band online supervision: The broadband/narrowband supervision checks the correctness of the measurement values used for the SAR calculation. With syngo MR XA20A, the supervision cycle is reduced significantly.
• LiverLab Dot Engine debundling: LiverLab is now offered separately as standalone workflow and is also still available as part of the Abdomen Dot Engine.
• The 1.5T system MAGNETOM Altea is made available to the marked with software syngo MR XA20A.

This document is a 510(k) summary for the Siemens MAGNETOM Sola, Altea, and Sola Fit MRI systems with software syngo MR XA20A. It outlines their substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device for a Magnetic Resonance Diagnostic Device (MRDD). The testing described is largely for demonstrating the safety and performance of new and modified hardware and software features in comparison to the predicate. It is not a clinical study proving diagnostic accuracy of an AI algorithm, a typical scenario for the detailed acceptance criteria you requested. Therefore, many of your specific questions regarding AI algorithm performance (e.g., MRMC studies, ground truth for training data, effect size of human improvement with AI) are not applicable or not explicitly detailed in this type of 510(k) submission for an MRI system.

The "acceptance criteria" here relate more to the performance and safety of the MRI system itself, rather than diagnostic accuracy of an AI algorithm based on a specific clinical endpoint.

Acceptance Criteria and Reported Device Performance

The document presents the testing conducted to support the substantial equivalence of the new and modified hardware and software components of the MAGNETOM systems. The "acceptance criteria" are implied by the successful completion of these nonclinical tests and their demonstration that the device performs as intended and is equivalent to the predicate.

Table of Acceptance Criteria and Reported Device Performance (Implied from Nonclinical Tests):

Study Details (Based on Provided Text)

Given that this is a 510(k) for an MRI system with new/modified features, and not an AI diagnostic algorithm, the "study" is a collection of nonclinical tests.

1. Sample size used for the test set and the data provenance:

   • The document states "Sample clinical images were provided" for image quality assessment. It does not specify the number of images or patients (sample size) used for these assessments.
   • Data provenance (country of origin, retrospective/prospective) is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For the "Image quality assessments by sample clinical images," it's stated, "when interpreted by a trained physician, yield information that may assist in diagnosis."
   • However, the number and qualifications of experts involved in the assessment of these sample clinical images for the purpose of the 510(k) submission are not specified. This is likely an internal verification step, not a formal clinical trial with external readers.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not specified. Given the nature of the nonclinical testing for device features, a formal adjudication process for "ground truth" (as expected for diagnostic performance studies) is not described. The assessments were likely internal comparisons to predicate performance.

4. 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 described. This 510(k) is for an MRI system, not an AI diagnostic algorithm. The improvements mentioned ("fast and efficient imaging," "reduce the workload") are theoretical benefits of the features themselves, not a quantified improvement in human reader performance with AI assistance. The document explicitly states "No additional clinical tests were conducted to support substantial equivalence for the subject devices."

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This document describes an MRI system, not a standalone AI algorithm. The software features are integrated into the system for image acquisition and processing.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The term "ground truth" as it pertains to clinical diagnostic accuracy is not explicitly used or established in this context. The "truth" for these nonclinical tests is based on the device meeting its engineering specifications, performing equivalently to the predicate, and producing images of acceptable quality when interpreted by a trained physician. The images themselves serve as the output, assessed against expected image quality parameters.

7. The sample size for the training set:

   • Not applicable / Not specified. This document describes a medical device (MRI system) with software and hardware features, not a machine learning model that requires a "training set" in the common sense. Any internal development data used to refine pulse sequences or image reconstruction is not considered a "training set" in the context of AI regulatory submissions.

8. How the ground truth for the training set was established:

   • Not applicable / Not specified. See point 7.

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