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510(k) Data Aggregation

    K Number
    K151007
    Device Name
    21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
    Manufacturer
    JVC KENWOOD CORPORATION
    Date Cleared
    2015-05-08

    (23 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K131137
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    21.3 inch (54 cm) inch Color Digital Mammography 5M pixel LCD Monitor CCL550i2 (CL21550) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

    Device Description

    CCL550i2 (CL21550) is a 21.3 inch (54 cm) color LCD monitor whose display resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.

    AI/ML Overview

    The provided text describes the JVC KENWOOD Corporation's 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2 (CL21550) and its substantial equivalence to a predicate device. This document is a 510(k) premarket notification to the FDA. It does not describe a study involving human readers or AI, but rather the technical specifications and testing of a medical display monitor.

    Therefore, many of the requested items related to clinical studies, human experts, and AI effectiveness are not applicable to the provided document. The information available focuses on engineering specifications and direct performance measurements of the display device.

    Here's a breakdown of the requested information based on the provided text, indicating "Not Applicable" or "Not Provided" where the information cannot be extracted:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (SPEC)Reported Device Performance
    Declared array size (spec): 422.4(H)mm x 337.92(V) mmActual array size (measured): 422.7(H)mm x 338.0(V)mm
    Luminance Max (Lmax)=1000cd/m², Luminance Min (typ) = 0.77cd/m² at Lmax=1000cd/m²Min.700cd/m² Typ. 1000cd/m² (as LCD component), 500cd/m² calibrated luminance. Minimum luminance at Lmax=1000cd/m² is not explicitly re-stated, but the calibrated luminance is 500 cd/m².
    Luminance Max recommend: Lmax(r)=500cd/m², Lmin(r)=0.8cd/m²Calibrated luminance is 500 cd/m².
    Intrinsic bit-depth of the panel: 10 bit per each pixel10.0 bit grayscale (1024 steps) achieved by 16bit LUT (Look-up Table)
    Intrinsic luminance response: dJND per dP<3.000, dJNDs/dP max error<2.000, JNDs/P RMS error<1.000 (based on AAPM-TG18 Advanced Luminance Response, 4.3.5)"Refer to actual luminance response data." (Specific numerical performance not provided in summary)
    Angular dependency of luminance: LR'≥175, Κδ>30%"Refer to actual Luminance uniformity data." (Specific numerical performance not provided in summary)
    Luminance uniformity: Less than 30% based on AAPM-TG18 4.4"Refer to actual Luminance uniformity data." (Specific numerical performance not provided in summary)
    Geometrical distortion: Less than 2.0% based on AAPM-TG18"Refer to actual Geometrical Distortion data." (Specific numerical performance not provided in summary)
    Bi-directional reflection distribution function: Refer to Max allowable ambient luminance in Tables 4 and 5 on AAPM-TG18 4.2.4."Refer to actual Reflectance Data." (Specific numerical performance not provided in summary)
    Pixel fill factor: 30% Min."Refer to Data of Pixel fill factor." (Specific numerical performance not provided in summary)
    Noise power spectrum (weiner spectrum)"Refer to actual data." (Specific numerical performance not provided in summary)
    Veiling glare: Glare Ratio (GR) ≥ 400 GR=(Lb-Ln)/(L-Ln) based on AAPM-TG18 4.7.4"Refer to actual veiling glare ratio data." (Specific numerical performance not provided in summary)
    Chromaticity: Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4"Refer to Chromaticity actual data." (Specific numerical performance not provided in summary)
    Artifacts: pixel dropouts including spatial distribution: Class (pixel) II. Refer to table 3 on 3.4.13 ISO13406-2."Refer to table 3 on 3.4.13 ISO13406-2." (Specific performance details not provided in summary)
    Artifacts: phase/clock issues flicker, ringing, ghosting, image sticking"By visible check, no ringing, ghosting image sticking." (Flicker, phase/clock issues not explicitly addressed as "no.")
    Spatial resolution, spatial MTF"Refer to actual MTF data." (Specific numerical performance not provided in summary)
    Temporal response: Rise Time Tr, Fall Time Tf, Tr, Tf<55mS."Refer to actual data." (Specific numerical performance not provided in summary)
    Stability: Ko within +/- 10% deviation to DICOM GSDF, based on AAPM-TG18 Luminance Response 4.3.4 via temperature stress 0 degC, 20 degC, 25 degC, 30 deqC, 40 deqC"Refer to actual measured data." (Specific numerical performance not provided in summary, but indicates testing was done across given temperatures.)
    Calibrated Luminance500cd/m²
    Contrast RatioMin.1000 : 1, Typ. 1300 : 1
    Grayscale10.0 bit (1024 gradation)

    2. Sample size used for the test set and the data provenance

    • Sample Size: Not Applicable. This device is a display monitor, not an AI or diagnostic algorithm, so there is no "test set" in the context of medical images or patient data. Its performance is evaluated through physical and optical measurements according to display standards.
    • Data Provenance: Not Applicable. The testing involves measurements of the monitor's physical characteristics, not medical image data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Not Applicable. Ground truth in this context refers to standardized measurements and specifications of the display, not clinical interpretations. Compliance is based on established display performance standards like AAPM-TG18.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

    • Not Applicable. This is not a clinical study involving diagnostic interpretations.

    5. 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

    • No. This is a technical submission for a display monitor, not an AI or diagnostic imaging device.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not Applicable. This product is a display monitor, not an algorithm. Its performance is inherently "standalone" in that it is measured as a device, without a "human-in-the-loop" component in its evaluation for this submission (though it is intended for human-in-the-loop diagnostic use). The study described is a technical performance test of the monitor itself.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    • The ground truth for the device's technical acceptance criteria is based on established industry standards and specifications for medical displays (e.g., AAPM-TG18, ISO13406-2) and the manufacturer's own specifications. These are objective, measurable physical parameters.

    8. The sample size for the training set

    • Not Applicable. This is a display monitor, not a machine learning model.

    9. How the ground truth for the training set was established

    • Not Applicable. This is a display monitor, not a machine learning model.
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