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510(k) Data Aggregation

    K Number
    K112604
    Date Cleared
    2011-10-27

    (50 days)

    Product Code
    Regulation Number
    892.2050
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K081056

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

    21.3 inch (54 cm) Color 3M pixel LCD Monitor CCL356i2 (CL21356) is intended 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

    CCL356i2 (CL21356) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1536 x 2048 (landscape), 2048 x 1536 (portrait) supporting DVI (digital visual interface) and Display Port.

    AI/ML Overview

    The provided text describes a 510(k) summary for a medical display device, the TOTOKU 21.3 inch (54 cm) Color LCD Monitor CCL356i2 (CL21356). It is not a document describing a study for a new AI/ML-based medical device. Therefore, the information required to answer the prompt regarding acceptance criteria and the study proving the device meets these criteria (such as performance metrics, sample sizes, ground truth establishment, or multi-reader multi-case studies) is not present in the provided text.

    The document states: "CCL3562 (CL21356) shares the same characteristics with our predicate device CCL354i2 (K081056) except for the power supply." This indicates that the device's acceptance criteria are primarily based on equivalence to a previously cleared predicate device, rather than explicit performance metrics derived from a clinical or technical study on image interpretation or diagnostic accuracy involving AI.

    Therefore, I cannot populate the table or answer the specific questions about performance studies, expert involvement, or adjudication methods based on the provided text. The document is a regulatory submission for a display monitor, not an AI/ML-driven diagnostic tool.

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