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510(k) Data Aggregation

    K Number
    K971271
    Device Name
    BESECURE EXTERNAL URINARY COLLECTION SYSTEM
    Manufacturer
    UROLOGY RESEARCH INTL., INC.
    Date Cleared
    1997-08-18

    (136 days)

    Product Code
    KNX
    Regulation Number
    876.5250
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROLOGY RESEARCH INTL., INC.

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

    The BeSECURE External Urinary Collection System is an external urine collection system for the incontinent patient.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) submission for the "BeSECURE External Urinary Collection System," and an "Indications for Use" statement.

    Unfortunately, this document does not provide any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The letter is a regulatory approval document stating that the device is substantially equivalent to legally marketed devices, implying that it has met certain regulatory requirements, but it does not detail the technical performance studies and their results.

    Therefore, I cannot fulfill your request for the specific information about:

    1. A table of acceptance criteria and the reported device performance
    2. Sample sized used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and their qualifications
    4. Adjudication method
    5. Whether a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
    6. Whether a standalone performance study was done
    7. The type of ground truth used
    8. The sample size for the training set
    9. How the ground truth for the training set was established
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