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510(k) Data Aggregation

    K Number
    K081055
    Device Name
    21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A)
    Manufacturer
    TOTOKU ELECTRIC CO., LTD.
    Date Cleared
    2008-06-04

    (51 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K063199
    Why did this record match?
    Reference Devices :

    K063199

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

    21.3-inch (54cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.

    Device Description

    CCL254i2 (CDL2125A) is a 21.3-inch (54cm) 2 megapixel Color LCD monitor that supports DVI video signal and provides UXGA (1200 x 1600) resolution for both landscape and portrait display.

    AI/ML Overview

    This document describes the 510(k) summary for a medical display device, the 21.3-inch (54 cm) 2M Color LCD Monitor CCL254i2 (CDL2125A). The information provided is primarily focused on the device's technical specifications and its substantial equivalence to a predicate device, rather than a detailed clinical study demonstrating its performance in a diagnostic context.

    Therefore, much of the requested information regarding clinical study methodology (sample size, expert qualifications, adjudication, MRMC studies, training set details) is not available in the provided text, as it doesn't describe such a study for this display monitor. The acceptance criteria and "reported device performance" are more about the display's technical capabilities validating its suitability for medical imaging rather than a direct measure of diagnostic accuracy.

    Here's the information that can be extracted or reasonably inferred from the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Inferred)Reported Device Performance (From 510(k) Summary)
    Display medical images for diagnosis by trained medical practitioners.Intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. (Implied that the technical specifications support this)
    Not to be used for digital mammography.It is not meant to be used for digital mammography. (Explicit statement)
    Technical specifications suitable for medical image display (e.g., resolution, color).2M Color LCD monitor that supports DVI video signal. Provides UXGA (1200 x 1600) resolution for both landscape and portrait display.
    Substantial equivalence to a legally marketed predicate device.Shares the same characteristics with predicate device CCL252i2 (CDL2120A) (K063199) except for power supply, front bezel, frame, fan, PCB and LCD screen.
    Meets Class II regulatory requirements for Picture Archiving and Communication Systems (PACS) monitors.Classified as Class II (Part 892 Radiology Devices, Sec. 892.2050 Picture Archiving and Communication System).

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

    • Not Applicable. This document does not describe a clinical test set or diagnostic study involving a sample of patient data. The "study" here refers to the technical validation of the display monitor itself against predetermined specifications and comparison to a predicate device.

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

    • Not Applicable. There is no mention of experts establishing ground truth for a test set in the context of a diagnostic study for this device. The assessment revolves around the monitor's technical compliance and substantial equivalence to a predicate.

    4. Adjudication method for the test set

    • Not Applicable. No test set or adjudication method for diagnostic performance is described.

    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 passive display monitor, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

    • No. This is a display monitor, not an algorithm. Its performance is evaluated based on its display characteristics.

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

    • Not Applicable in the traditional sense of a diagnostic study. For this device, the "ground truth" would be the required technical specifications for medical display monitors and the performance characteristics of the predicate device (K063199). The device's performance is measured against these technical standards.

    8. The sample size for the training set

    • Not Applicable. As a display monitor, there is no AI algorithm being trained, and thus no training set.

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

    • Not Applicable. Refer to point 8.
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