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510(k) Data Aggregation

    K Number
    K962153
    Device Name
    DIGITAL IMAGE ANALYSIS SYSTEM
    Manufacturer
    UNIVERSITY OF WASHINGTON
    Date Cleared
    1997-01-17

    (227 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    UW LV Analysis Software assists in measuring left ventricular volume at end diastole and end systole, ejection fraction, and regional wall motion around the ventricular contour. The intended applications of the software are: 1) to assist in evaluating a patient with suspected heart disease, 2) to measure the effectiveness of therapy, 3) to assess risk or prognosis, and 4) in clinical trials evaluating new therapies.

    Device Description

    The method comprises five main parts: a) reviewing the digital images, b) selecting the image frames to analyze, c) identifying and tracing the border of the left ventricle, d) measuring left ventricular volume from the traced border and calculating ejection fraction, and e) measuring regional wall motion. The UN LV Analysis Software allows the user to review a series of images in digital format, and manually select frames for analysis. Identifying and tracing the ventricular border is performed manually using the Of the techniques developed to measure left LV Analysis Software. UW ventricular volume from a traced border, the area length method is generally the most accurate, and is the method used by the UW LV Analysis accepted as Software. Of the techniques for measuring left ventricular wall motion, the centerline method has been proven useful for clinical trials, and is the method used by the UW LV Analysis Software. Calibration to correct for image magnification is required for volume measurement, but not for calculation of the ejection fraction or for analysis of regional wall motion.

    AI/ML Overview

    Here's an analysis of the provided text, focusing on the acceptance criteria and the study details, presented in the requested format:

    Acceptance Criteria and Device Performance Study

    The provided document describes the UW LV Analysis Software, which assists in measuring left ventricular volume, ejection fraction, and regional wall motion. This software is largely a manual tool with automated calculations based on user input.

    1. Table of Acceptance Criteria and Reported Device Performance

    MetricAcceptance CriteriaReported Device Performance
    Difference from reference programs (volume & regional wall motion)
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