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510(k) Data Aggregation

    K Number
    K183254
    Device Name
    Magnetom Vida
    Manufacturer
    Siemens Medical Solutions, USA, Inc.
    Date Cleared
    2019-01-18

    (58 days)

    Product Code
    LNH,LNI,MOS
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K163234,K150843,K181433
    Why did this record match?
    Reference Devices :

    K163234, K150843

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectroscopic 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 yicld 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.

    Device Description

    MAGNETOM Vida with software syngo MR XA11B includes new and modified component, features and software compared to the predicate device, MAGNETOM Vida with syngo MR XA11A. A high level summary of the new and modified features is provided below:

    Hardware
    New Hardware

    • Nose Marker for Inline Motion Correction
      Software
      New Features and Applications
    • TFL with Inline Motion Correction: Tracking of motion of the head during 3D MPRAGE head scans with a nose marker and a camera system. The MR system uses the tracking information to compensate for the detected motion.
    • i GOLiver: 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.
    • 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.
    • SEMAC: SEMAC is a method for metal artifact correction in ortho imaging of patients i with whole joint replacement. Using Compressed Sensing the acquisition can be accelerated.
    • Angio TOF with Compressed Sensing: The Compressed Sensing (CS) functionality is now available for TOF MRA within the BEAT pulse sequence type. 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.
    • SMS for RESOLVE and QDWI: Simultaneous excitation and acquisition of multiple i slices with the Simultaneous multi-slice (SMS) technique for readout-segmented echo planar imaging (RESOLVE) and quiet diffusion weighted imaging (QDWI).
    • i SPACE with Compressed Sensing: 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.
    • RT Respiratory self-gating for FL3D_VIBE: Non-contrast abdominal and thoracic i examination in free breathing with reduced blur induced by respiratory motion.
      Other Modifications and / or Minor Changes
    • i Turbo Suite is a marketing bundle of components for accelerated MR imaging offered for the MAGNETOM Vida MR systems.
    • i Noise masking: a mechanism to remove the noise floor in outer regions is now available for RESOLVE and QDWI.
    AI/ML Overview

    The provided FDA 510(k) summary for the MAGNETOM Vida (K183254) does not contain the specific details for acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-based medical devices or devices with new diagnostic functionalities.

    This 510(k) is for an updated version of an existing MRI system (MAGNETOM Vida with software syngo MR XA11B) compared to its predicate (MAGNETOM Vida with syngo MR XA11A). The changes primarily involve new hardware (1 mention) and several new or modified software features for image acquisition and processing (e.g., motion correction, optimized pulse sequences, metal artifact correction, accelerated imaging techniques).

    The document states: "No clinical tests were conducted to support substantial equivalence for the subject device; however, sample clinical images were provided to support the new/modified component and software features per the FDA guidance document 'Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices', dated November 18, 2016."

    This indicates that the primary focus of the submission was on demonstrating that the new features maintain the safety and performance profile of the predicate device through non-clinical testing (image quality assessments, software verification/validation) and by providing sample clinical images (not a formal clinical study with acceptance criteria).

    Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text because such a detailed study with acceptance criteria, ground truth, expert readers, and effect sizes was not performed or described in this 510(k) submission for this specific device clearance.

    Below, I will indicate which information is not present in the document and briefly explain why, based on the nature of this 510(k) (which is for an updated MRI system, not an AI/ML diagnostic algorithm).

    Acceptance Criteria and Study for MAGNETOM Vida (K183254)

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    NOT PRESENT. This 510(k) does not define specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its new features. The submission focuses on demonstrating through non-clinical testing that the new features maintain an equivalent safety and performance profile to the predicate device.NOT PRESENT. No specific performance metrics against clinical acceptance criteria are reported. The document states "The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device." This refers to non-clinical tests (image quality assessments, software verification/validation).

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

    • Sample Size for Test Set: NOT PRESENT. The document mentions "sample clinical images were provided," but it does not specify the number of images or patients used for these samples, nor does it describe a formal "test set" in the context of a diagnostic performance study.
    • Data Provenance (country of origin, retrospective/prospective): NOT PRESENT. The origin of the "sample clinical images" is not specified.

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

    • NOT APPLICABLE/NOT PRESENT. Since no formal clinical study with a defined "test set" and "acceptance criteria" was described for diagnostic performance, there's no mention of experts establishing ground truth for such a study. The product is an MRI system, and interpretations are made by "trained physicians."

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

    • NOT APPLICABLE/NOT PRESENT. No formal adjudication method is described, as no specific clinical diagnostic performance test set requiring such expert consensus was presented in this 510(k).

    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:

    • NO. An MRMC study was not conducted or described for this submission. This device is an MRI scanner with new and modified acquisition and processing features, not an AI-assisted diagnostic tool that directly aids human readers to improve diagnostic accuracy.

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

    • NO. This is an MRI system. Its "performance" is inherently tied to image acquisition and quality, which are then interpreted by a human. It does not perform a standalone diagnostic function like an AI algorithm for disease detection.

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

    • NOT APPLICABLE/NOT PRESENT. No formal ground truth definition is provided for a clinical performance study since one was not conducted for the purpose of demonstrating substantial equivalence. The device's performance was evaluated through non-clinical tests (e.g., image quality assessments).

    8. The sample size for the training set:

    • NOT APPLICABLE/NOT PRESENT. The document describes software modifications including some advanced imaging techniques (e.g., Compressed Sensing). While these might involve optimization based on data, the submission does not describe a traditional "training set" in the context of an AI/ML algorithm development or a diagnostic study. The software development and testing follow IEC 62304 and other relevant standards.

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

    • NOT APPLICABLE/NOT PRESENT. As no "training set" in the context of diagnostic AI/ML was described, no information on its ground truth establishment is provided.
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