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510(k) Data Aggregation

    K Number
    K050496
    Device Name
    REM440
    Manufacturer
    INTERACOUSTICS A/S, ASSENS
    Date Cleared
    2005-04-29

    (60 days)

    Product Code
    ETW
    Regulation Number
    874.3310
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    REM440

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

    The REM440 system is intended to be used as a system to perform Real Ear Measurement and assist in the adjustment of hearing aids while in use by the patient. It is used by ENT-professionals and in clinics for hearing aid fitting. This device can either be sold individually or together with other Thor Platform modules in the same housing.

    Device Description

    REM440, (for use with Thor Platform System Products)

    AI/ML Overview

    The provided text is a 510(k) substantial equivalence letter from the FDA for the Interacoustics REM440 device, a hearing aid analyzer. It does not contain the detailed information necessary to answer the questions about acceptance criteria and study design.

    Specifically, the document states:

    • Device Name: REM440
    • Regulation Number/Name: 21 CFR 874.3310 / Hearing Aid Analyzer
    • Indications For Use: "The REM440 system is intended to be used as a system to perform Real Ear Measurement and assist in the adjustment of hearing aids while in use by the patient. It is used by ENT-professionals and in clinics for hearing aid fitting. This device can either be sold individually or together with other Thor Platform modules in the same housing."
    • Date of Decision: April 29, 2005 (corrected from an earlier letter of the same date).
    • 510(k) Number: K050496

    However, it does not contain any information regarding:

    1. Acceptance criteria or reported device performance.
    2. Sample sizes for test sets or data provenance.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication methods.
    5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
    6. Standalone algorithm performance studies.
    7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    The letter is a regulatory document confirming substantial equivalence to a predicate device, which allows the device to be marketed. It does not elaborate on the specific technical or clinical studies that may have been submitted in the original 510(k) application to demonstrate this equivalence. To find that information, one would typically need to review the full 510(k) submission summary or other related technical documentation, which is not provided in the given text.

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