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510(k) Data Aggregation

    K Number
    K232919
    Device Name
    Ambu® aScope™ Gastro Large; Ambu® aBox™ 2
    Manufacturer
    Ambu A/S
    Date Cleared
    2024-04-05

    (199 days)

    Product Code
    FDS,FET
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K212382
    Why did this record match?
    Device Name :

    Ambu**®** aScope™ Gastro Large; Ambu® aBox™ 2

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

    Ambu® aScope™ Gastro Large:
    The endoscope is a sterile, single-use, flexible gastroscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy.
    The endoscope is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.
    The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

    Device Description

    The Ambu® aScope™ Gastro Large Endoscopy System is a system used for endoscopic procedures in the upper gastrointestinal anatomy. It consists of a sterile, single-use, flexible endoscope, the Ambu® aScope™ Gastro Large, and a displaying unit, the Ambu® aBox™ 2.

    AI/ML Overview

    The provided text does NOT describe an AI/ML-driven device or study. It is a 510(k) summary for a medical device called the Ambu® aScope™ Gastro Large Endoscopy System. This system is an endoscope and a display unit used for examining the upper gastrointestinal anatomy.

    The document discusses various performance tests relevant to a physical medical device (e.g., geometrical characteristics, functional performance of insufflation/suction, optical performance, biocompatibility, sterilization, electrical safety, etc.). It explicitly states that the device has "similar technological characteristics and principles of operation" to its predicate devices, with only "minor technological differences" that "raise no new concerns regarding safety or effectiveness."

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria from an AI/ML perspective, as the provided text pertains to a traditional, non-AI medical device. The information you requested (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are specific to the evaluation of AI/ML algorithms, which are not mentioned or implied in this document.

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