LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K211432
    Device Name
    Myomics Q
    Manufacturer
    Phantomics Inc.
    Date Cleared
    2021-11-23

    (200 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K141480,K082628
    Why did this record match?
    Device Name :

    Myomics Q

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

    Myomics Q is intended to be used for viewing, post-processing and analysis of cardiac magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables:

    • Importing cardiac MR images in DICOM format.
    • Supporting clinical diagnostics by analysis of cardiac MR images using display functionality such as panning, windowing, zooming through series/slices of the images.
    • Supporting clinical diagnostics analysis of the heart in cardiac MR images and signal intensity.
    • Software package is designed to support the physician compliance assessment, document and follow up heart disease by cardiac MRI.

    It shall be used by qualified medical professionals, experienced in examining cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. This device is a software application that can be used as a stand-alone product or in a network environment.

    The target population for the device is not restricted, however the image acquisition by a cardiac MR scanner may limit the use of the device for certain sectors or the public.

    Device Description

    Myomics Q is software application for evaluating cardiovascular images in a DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. This device has a graphical user interface which allows users to analyze cardiac MR Images qualitatively and quantitatively.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the Myomics Q device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state formal acceptance criteria with specific thresholds for each performance metric. Instead, the performance tests verify the proper functioning of features and quantitative comparisons against a reference device within a certain margin. The implicit acceptance criterion for the quantitative comparisons is that the results should be "very similar" and fall within a ±5% deviation from the reference device.

    Acceptance Criteria (Implicit)Reported Device Performance
    Functional Verification
    Proper installation of Myomics Q on appropriate OS (Window)Passed (SPPT001)
    Import cardiac MR Images function working properlyPassed (SPPT002)
    Export cardiac MR Images function working properlyPassed (SPPT003)
    Patient information function working properlyPassed (SPPT004)
    Series overview function working properlyPassed (SPPT005)
    Contour drawing functions (Endocardium, Epicardium, Move, Pinch, Nudge, Curved Line, Free Hand, Smoothing, Undo, Redo, Restart, Delete, Confirm, Zooming, Panning, Windowing) working properlyPassed (SPPT006)
    T1 analysis function working properly (T1 Image or T1 Map display)Passed (SPPT007)
    T2 analysis function working properly (T2 Image or T2 Map display)Passed (SPPT008)
    LGE analysis function working properly (LGE Image display)Passed (SPPT009)
    Quantitative Comparison (Implicit Acceptance Threshold: ≤ ±5% deviation from cvi42)
    Results of Myomics Q are very similar to cvi42 in polar map report in Native T1 analysisThe results of Myomics Q did not show a difference of more than ±5% compared to the results of cvi42 (95% of cvi42 results
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1