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510(k) Data Aggregation

    K Number
    K163492
    Device Name
    Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear
    Manufacturer
    United states Endoscopy Group, Inc.
    Date Cleared
    2017-01-06

    (24 days)

    Product Code
    FDF
    Regulation Number
    876.1500
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear

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

    The US Endoscopy EUS Balloon is intended to be used in endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the upper and lower gastrointestinal tract.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves a device meets such criteria. The document is a letter from the FDA to United States Endoscopy Group, Inc. regarding a 510(k) premarket notification for "Oracle EUS Balloon" and its variations. It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. It also includes an "Indications for Use" statement.

    However, it does not contain:

    • A table of acceptance criteria and reported device performance.
    • Details on sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for any tests.
    • Information regarding training sets or how ground truth was established for them.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the given text.

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