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510(k) Data Aggregation

    K Number
    K183137
    Device Name
    uMR 580, uMR 588
    Manufacturer
    Shanghai United Imaging Healthcare Co., Ltd.
    Date Cleared
    2019-01-11

    (59 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K180925,K180926
    Why did this record match?
    Reference Devices :

    K180925

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

    The uMR 580/uMR 588 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities.

    These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.

    Device Description

    The uMR 580/uMR 588 is a 1.5T superconducting magnetic resonance diagnostic device with a 60cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 580/uMR 588 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

    AI/ML Overview

    The provided text is a 510(k) summary for the uMR 580/uMR 588 Magnetic Resonance Diagnostic Device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the context of a clinical performance study for an AI/ML medical device.

    Therefore, much of the requested information (acceptance criteria table, sample sizes for test/training sets, expert details, adjudication methods, MRMC study details, ground truth types, etc.) is not present in this document.

    However, based on the information provided, here's what can be extracted:

    Acceptance Criteria and Device Performance (Limited Information)

    The document states that a series of non-clinical tests were conducted, and these tests demonstrated that the device performs as expected and is substantially equivalent to the predicate. The "acceptance criteria" here are implied to be conformance to established standards and the successful achievement of certain measurement outcomes in those tests. The "reported device performance" is a general statement of success rather than specific quantitative metrics against a defined threshold.

    Acceptance Criterion (Implied)Reported Device Performance
    Conformance to various IEC/ISO standards for medical electrical equipment, safety, and biological evaluation."The test results demonstrated that the device performs as expected."
    Conformance to NEMA and DICOM standards."The uMR 580/uMR 588 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards."
    Ability to generate diagnostic quality images (Clinical Image Review)."Sample clinical images were provided to support the ability of uMR 580/uMR 588 to generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions."
    Measurement of SNR (Signal-to-Noise Ratio) in MR images."The test results demonstrated that the device performs as expected." (Implied success based on MS 1-2008(R2014) standard)
    Measurement of 2D Geometric Distortion in MR images."The test results demonstrated that the device performs as expected." (Implied success based on MS 2-2008(R2014) standard)
    Measurement of Image Uniformity in MR images."The test results demonstrated that the device performs as expected." (Implied success based on MS 3-2008(R2014) standard)
    Acoustic Noise Measurement."The test results demonstrated that the device performs as expected." (Implied success based on MS 4-2010 standard)
    Determination of Slice Thickness in MR Imaging."The test results demonstrated that the device performs as expected." (Implied success based on MS 5-2010 standard)
    Determination of SNR and Image Uniformity for Single-Channel Non-Volume Coils."The test results demonstrated that the device performs as expected." (Implied success based on MS 6-2008(R2014) standard)
    Characterization of SAR (Specific Absorption Rate)."The test results demonstrated that the device performs as expected." (Implied success based on MS 8-2008 standard)
    Characterization of Phased Array Coils."The test results demonstrated that the device performs as expected." (Implied success based on MS 9-2008(R2014) standard)

    Missing Information (Not Available in the Document):

    • Sample sized used for the test set and the data provenance: Not specified. The document mentions "sample clinical images were provided," but no details on quantity, origin, or retrospective/prospective nature.
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
    • Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
    • 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: Not conducted or reported. This device is a Magnetic Resonance Diagnostic Device (hardware), not an AI/ML algorithm designed to assist readers.
    • If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device.
    • The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "sample clinical images," the ground truth is implicitly "diagnostic quality images" as interpreted by a trained physician, but no formal ground truth establishment process is described.
    • The sample size for the training set: Not applicable, as this is a hardware device submission, not an AI/ML algorithm, and thus doesn't have a "training set" in that context.
    • How the ground truth for the training set was established: Not applicable.

    Summary of the Study type:

    The study described is a series of non-clinical bench tests (conformance to various safety, performance, and measurement standards for MRI devices) and a limited clinical image review (assessment of diagnostic quality of sample images). It is a substantial equivalence demonstration for a hardware medical device (MRI scanner), not a performance study for an AI/ML algorithm. Therefore, many of the questions asked, which are typical for AI/ML device submissions, are not relevant or answered by this document.

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