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510(k) Data Aggregation

    K Number
    K973376
    Device Name
    LORI/LORI, LORI-S (LORI STOCK AID)
    Manufacturer
    LORI MEDICAL LABORATORIES, INC.
    Date Cleared
    1997-10-14

    (36 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The indication for use of the air conduction hearing aids in this submission is to anglify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(fes), (Check appropriate space(s)); Severity: Mild, Moderate. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Flat. Other: Low tolerance To Loudness.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for a hearing aid from 1997. While it mentions the indications for use and states that the device is "substantially equivalent" to previously marketed devices, it does not provide:

    • A table of acceptance criteria and reported device performance.
    • Details of a specific study, including sample sizes, data provenance, ground truth establishment, or expert qualifications.
    • Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.

    The letter is a regulatory approval document based on a past submission, not a detailed technical report of the studies performed.

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