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510(k) Data Aggregation

    K Number
    K120290
    Device Name
    TOSHIBA 1.5T CARDIAC COIL
    Manufacturer
    QUALITY ELECTRODYNAMICS
    Date Cleared
    2012-02-28

    (28 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K093667,K091114,K112313,K061952
    Why did this record match?
    Reference Devices :

    K093667, K091114, K112313

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

    The Toshiba 1.5T Cardiac coil is intended for use with the Toshiba 1.5T Vantage Titan MRI system to produce diagnostic images of the heart that can be interpreted by a trained physician.

    Device Description

    The Toshiba 1.5T Cardiac Coil is designed for use with the Toshiba 1.5T MRI system manufactured by Toshiba Medical Systems Corporation.

    AI/ML Overview
    1. Acceptance Criteria and Reported Device Performance:

    The provided 510(k) summary does not explicitly state numerical acceptance criteria for the Toshiba 1.5T Cardiac Coil. Instead, it describes performing tests and found the device "compliant with IEC 60601-1" and that SNR was "measured according to Toshiba Medical Systems Corporation's internal protocol" and Image Uniformity was "assessed in accordance with NEMA MS-3 2008".

    Test/MetricAcceptance CriteriaReported Device Performance
    Basic Safety and Essential PerformanceCompliance with IEC 60601-1 (second and third editions)Found compliant
    Signal-to-Noise Ratio (SNR)N/A (Measured per internal protocol, no specific threshold stated in document)Measured according to Toshiba Medical Systems Corporation's internal protocol. Specific values are not provided.
    Image UniformityN/A (Assessed per NEMA MS-3 2008, no specific threshold stated in document)Assessed in accordance with NEMA MS-3 2008. Specific results are not provided.

    1. Sample Size for Test Set and Data Provenance:
      The document does not specify a separate "test set" in the context of clinical images or diagnostic performance. The testing described relates to the physical and electrical performance of the coil. Therefore, information on sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided in this summary.

    2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
      N/A - This information is not relevant as the study focuses on the technical performance of the MRI coil itself, not the diagnostic interpretation of images by experts.

    3. Adjudication Method for the Test Set:
      N/A - Not applicable as the study evaluates the technical performance of the device, not diagnostic interpretations from a test set requiring adjudication.

    4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
      No, an MRMC comparative effectiveness study was not done. The document focuses on the technical performance specifications of the MRI coil and does not involve human readers' interaction with or interpretation of images, nor does it assess improvement with or without AI assistance.

    5. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
      N/A - This is not an AI/algorithm-driven device. It is an MRI coil, a hardware component for imaging. Therefore, a standalone algorithm performance evaluation would not be relevant.

    6. Type of Ground Truth Used:
      For the tests conducted (IEC 60601-1, SNR, Image Uniformity), the "ground truth" refers to established technical standards and measurement protocols, rather than a clinical "ground truth" from pathology or outcomes data. The ground truth for these tests is the physical and electrical characteristics of the coil as measured against specifications.

    7. Sample Size for the Training Set:
      N/A - This document does not describe the development of an AI algorithm or a "training set." The device is an MRI coil, a hardware component.

    8. How the Ground Truth for the Training Set Was Established:
      N/A - There is no training set mentioned or implied as this is a hardware device.

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