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510(k) Data Aggregation

    K Number
    K963326
    Device Name
    BREATHE FIT
    Manufacturer
    CAMBRIDGE ASSOC.
    Date Cleared
    1997-02-12

    (173 days)

    Product Code
    LWF
    Regulation Number
    874.3900
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K192534,K191974
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAMBRIDGE ASSOC.

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text "FEB 1 2 1997... Product Name: BREATHE FIT™... Sponsor's Name: Cambridge Associates... SUBSTANTIAL EQUIVALENCE... Breathe Fit™ is substantially equivalent to another commercially available product which uses similar methodology for improving nasal air flow to allow freer breathing. Manufacturer : CNS, Inc. Product: Breathe Right -A drug free, non-prescription adhesive device that mechanically improves nasal breathing by opening the nasal passages." is a 510(k) summary for a nasal dilator and does not contain any information about acceptance criteria, study details, or performance metrics for the BREATHE FIT™ device.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set or data provenance.
    3. Number of experts used or their qualifications for ground truth.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance information.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (Breathe Right) based on similar methodology and intended use, rather than providing detailed performance study data. To answer your questions, I would need a significantly more detailed document, such as a full clinical study report, a performance characteristics section of a regulatory submission, or a peer-reviewed publication about the device.

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