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510(k) Data Aggregation

    K Number
    K160351
    Device Name
    CX50N, CX50YQS
    Manufacturer
    WIDE Corporation
    Date Cleared
    2016-04-07

    (59 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K160326
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CX50N(CX50YQS) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.

    Device Description

    CX50N(CX50YQS) is a flat panel hi-resolution(5MP) LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale and color image display. The WIDE controller board is installed into the PACS workstation computer or other computer system to display PACS medical images.

    AI/ML Overview

    Here's the breakdown of the acceptance criteria and study information for the CX50N(CX50YQS) LCD Monitor System, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (from International/FDA-recognized consensus standards)Reported Device Performance (CX50N(CX50YQS))
    ResolutionMet acceptance criteria specified in the standardsMeets standards
    Luminance (Brightness)Met acceptance criteria specified in the standardsMeets standards
    ContrastMet acceptance criteria specified in the standardsMeets standards
    NoiseMet acceptance criteria specified in the standardsMeets standards
    Electrical SafetyIEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential PerformanceComplies (validated through tests)
    Electromagnetic CompatibilityIEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And TestsComplies (validated through tests)

    Note: The document states that the individual tests (resolution, luminance, contrast, noise) "all met the acceptance criteria specified in the standards," but it does not explicitly list the numerical acceptance criteria from those standards. The reported device performance is that it "meets standards."

    2. Sample Size Used for the Test Set and Data Provenance

    • Test Set Sample Size: Not applicable. This device is an LCD monitor system, and the non-clinical testing focused on physical performance characteristics against established standards, not on evaluating diagnostic accuracy using a dataset of medical images.
    • Data Provenance: Not applicable for a traditional test set as described for AI/ML devices. The testing involved measurements of the monitor's physical characteristics and compliance with electrical and EMC standards.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

    • Not applicable. Ground truth, in the context of medical image interpretation, is not established for this type of device (a display monitor) in this submission. The "ground truth" for the non-clinical tests would be the established specifications and limits defined by the referenced international standards.

    4. Adjudication Method for the Test Set

    • Not applicable. There was no image interpretation test set requiring expert adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

    • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an LCD monitor, not an AI-assisted diagnostic tool.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

    • Not applicable. This is an LCD monitor system, not an algorithm. Performance testing was of the hardware itself against technical standards.

    7. The Type of Ground Truth Used

    • The "ground truth" for the non-clinical performance and safety tests was the established technical specifications and limits defined within the cited international and FDA-recognized consensus standards (e.g., IEC 60601-1, IEC 60601-1-2).

    8. The Sample Size for the Training Set

    • Not applicable. This device is an LCD monitor system and does not involve AI/ML requiring a training set.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable. This device is an LCD monitor system and does not involve AI/ML requiring a training set.
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