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Your MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal, and oblique cross sectional mages, spectroscopic images and or spectra, and that displays the internal structure and/or function of the head, body, or extremittes. 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 plysical 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 display and MR-Safe biopsy needles.

MAGMETOM Vida, MAGNETOM Lumina, and MAGNETOM Vida Fit with software synqo MR XA20A include new and modified hardware and software compared to the predicate device, MAGNETOM Vida with syngo MR XA11B. A high level summary of the hardware and software is provided below:

Hardware: Computer, Coils (BM Body 18)

Software Features and Applications: SMS for TSE DIXON, GOLiver, Angio TOF with Compressed Sensing (CS), RT Respiratory self-gating for FL3D VIBE, SMS for RESOLVE and QDWI, SPACE with Compressed Sensing (CS), i SEMAC, TSE_MDME, TSE and GRE with Inline Motion Correction, EP SEG PHS, GRE PHS, GRE_Proj, GOKnee2D, BEAT_interactive, EP2D_SE_MRE, ZOOMit DWI, SPACE Flair Improvements, External Phase Correction Scan for EPI Diffusion, MR Breast Biopsy Workflow improvements, GOBrain / GOBrain+

Software / Platform: Dot Cockpit, i Access-i, Table positioning mode

Other Modifications and / or Minor Changes: MAGNETOM Vida Fit, i BM Body 12, Body 18, UltraFlex Large 18, UltraFlex Small 18, Broad band / narrow band online supervision, LiverLab Dot Engine - debundling

The Siemens Medical Solutions USA, Inc. 510(k) submission for the MAGNETOM Vida, MAGNETOM Lumina, and MAGNETOM Vida Fit with software syngo MR XA20A and new hardware (BM Body 18 Coil) does not include a study to determine specific acceptance criteria for device performance. Instead, the submission relies on non-clinical tests to demonstrate substantial equivalence to a predicate device (MAGNETOM Vida with syngo MR XA11B).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide explicit acceptance criteria with quantitative targets for the device's performance in terms of diagnostic accuracy, sensitivity, specificity, or other clinical metrics. The "device performance" reported is largely in the context of demonstrating equivalence through image quality assessments and conformance to standards.

2. Sample Size Used for the Test Set and Data Provenance:

The submission does not specify a distinct "test set" in the context of a clinical study for measuring diagnostic performance. For image quality assessments:

• Sample size: Not explicitly stated. The document refers to "sample clinical images" and "comparison images."
• Data provenance: Not specified. It doesn't mention the country of origin or whether the images were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable, as no formal clinical study with a defined test set and ground truth establishment by experts for diagnostic evaluation is described. The "interpretation by a trained physician" is mentioned in the Indications for Use, which refers to the end-user clinical interpretation of the images, not the establishment of ground truth for a study.

4. Adjudication Method for the Test Set:

Not applicable, as no formal clinical study with a defined test set and expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or reported in this submission to evaluate the effectiveness of human readers with vs. without AI assistance. The submission describes improvements to an MR diagnostic device and its software, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This submission focuses on improvements to an MR imaging system and its software features, not a standalone AI algorithm for diagnosis. The device's output (images and spectra) is explicitly stated to require interpretation by a trained physician.

7. Type of Ground Truth Used:

Ground truth, in the context of diagnostic accuracy for a clinical study, was not used in this submission. The assessments focused on technical performance, image quality, and compliance with standards, often by comparing the new features/hardware to the predicate device or existing functionalities.

8. Sample Size for the Training Set:

Not applicable. The submission does not describe an AI/machine learning algorithm that requires a training set in the typical sense of a diagnostic AI product. The software updates are improvements to the MR imaging system itself, which do not inherently involve a "training set" for an AI model to learn from.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no described training set or AI model in this context.

Summary of the Study:

The submission highlights non-clinical performance testing and refers to clinical publications for specific features. The "study" described is primarily a set of engineering and verification/validation tests to demonstrate that the new hardware (BM Body 18 coil) and software features (e.g., SMS for TSE DIXON, GOLiver, Angio TOF with Compressed Sensing, RT Respiratory self-gating) perform as intended and do not raise new questions of safety or effectiveness compared to the predicate device.

The non-clinical tests included:

• Sample clinical images with image quality assessments (sometimes compared to predicate device features).
• Performance bench tests for hardware.
• Software verification and validation (following FDA guidance).
• Biocompatibility testing (ISO 10993-1).
• Electrical, mechanical, structural, and related system safety tests (AAMI/ANSI ES60601-1, IEC 60601-2-33).
• Electrical safety and electromagnetic compatibility (EMC) tests (IEC 60601-1-2).

The conclusion of these tests was that the subject devices perform as intended and are substantially equivalent to the predicate device. No clinical studies demonstrating diagnostic accuracy or changes in human reader performance were part of this 510(k) submission.

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