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510(k) Data Aggregation

    K Number
    K030413
    Device Name
    Y2K2 ENTERNAL FEEDING MANAGER
    Manufacturer
    MOSS MEDICAL PRODUCTS
    Date Cleared
    2004-05-11

    (459 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Y2K2 Enteral Feeding Manager functions to provide enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. The device will accurately deliver small volumes enterally, and be capable of intermittently measuring residual volumes

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Y2K2 Enteral Feeding Manager". It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

    The letter is a regulatory approval document and not a performance study report. Therefore, I cannot extract the requested information.

    To elaborate on why the requested information isn't available in the provided text:

    • Acceptance Criteria and Reported Device Performance: This document is an approval letter, not a technical report detailing performance metrics.
    • Sample size and data provenance for test set: Not mentioned.
    • Number of experts and qualifications to establish ground truth for test set: Not mentioned.
    • Adjudication method for the test set: Not mentioned.
    • MRMC comparative effectiveness study: Not mentioned.
    • Standalone algorithm performance: Not mentioned, and this is a physical medical device, not an AI algorithm.
    • Type of ground truth used: Not mentioned.
    • Sample size for training set: Not mentioned.
    • How ground truth for training set was established: Not mentioned.
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