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510(k) Data Aggregation

    K Number
    K160328
    Device Name
    DIVA ZSP2105CMI with QUBYX PerfectLum bundle
    Manufacturer
    THE LINDEN GROUP CORP.
    Date Cleared
    2016-02-25

    (20 days)

    Product Code
    PGY,DAT
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K151883
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DIVA ZSP2105CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, including those of mammography, for review, analysis and diagnosis by trained medical practitioners.

    The DIVA ZSP2105CMI can be used only in conjunction with QUBYX PerfectLum.

    The device can not be used for a life-support system.

    The device does not contact with the patient.

    The device is intended for prescription use.

    Device Description

    The DIVA ZSP2105CMI with QUBYX PerfectLum is a 21.3" monochrome display for medical viewing. It can be used for diagnostic viewing or normal reviewing purpose of medical images like computed tomography images, digitalized x-ray images, etc. It is combined with QUBYX PerfectLum and PerfectLum Remote Management, a user-friendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM GSDF, displaying test patterns and performing acceptance and constancy tests according to AAPM TG18.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the DIVA ZSP2105CMI with QUBYX PerfectLum bundle:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document describes the device's compliance with two key standards rather than setting specific numerical acceptance criteria for a clinical study with patients. The performance is reported as meeting these standards.

    Acceptance CriterionReported Device Performance
    DICOM Part 14 GSDF ConformanceThe display device successfully passed DICOM conformance test and is compliant with DICOM Part 14 GSDF standard.
    AAPM TG18 Acceptance TestThe display device successfully passed AAPM TG18 acceptance test and is compliant with AAPM TG18 standard, enabling its use as a primary category display for medical image interpretation.

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

    • Sample Size: The document does not specify a "sample size" in the context of patients or medical images. The testing described focuses on a single instance of the DIVA ZSP2105CMI with QUBYX PerfectLum device.
    • Data Provenance: Not applicable in the traditional sense of patient data. The tests were performed using software-generated patterns and measurements on the device itself. The tests were performed by QUBYX and verified by the University of Arizona.

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

    • Number of Experts: The document does not mention the use of experts to establish "ground truth" for a test set of medical images. The ground truth for the technical performance was established by measurement devices and software comparing device output to defined standards (DICOM, AAPM).
    • Qualifications of Experts: Not applicable. For the visual steps of the AAPM TG18 test, it mentions "the user analyzed test patterns," but it doesn't specify if this user was a medical expert or their qualifications.

    4. Adjudication Method for the Test Set:

    • Adjudication Method: Not applicable. The "test set" in this context refers to the device's technical specifications and adherence to standards, which are evaluated by measurement tools and software against predefined targets, not by a panel of human adjudicators.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

    • MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a medical display, not an AI algorithm designed to assist human readers directly.
    • Effect Size: Not applicable.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

    • Standalone Performance: Not applicable. The device itself is a display monitor and calibration software. Its performance is evaluated on its ability to accurately display images according to standards, not as an AI algorithm that produces an output on its own.

    7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

    • Type of Ground Truth: The ground truth used was conformance to established technical standards:
      • DICOM Part 14 GSDF Standard: For grayscale display function.
      • AAPM TG18 Standard: For diagnostic display quality and acceptance testing.
        These standards define objective criteria for luminance, contrast, uniformity, and resolution.

    8. The Sample Size for the Training Set:

    • Sample Size for Training Set: Not applicable. This device is not an AI algorithm that requires a training set of data.

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

    • Ground Truth for Training Set: Not applicable.
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