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510(k) Data Aggregation

    K Number
    K972543
    Device Name
    TWIST PPAGC-1, TWIST PP
    Manufacturer
    TRUTONE
    Date Cleared
    1997-07-23

    (14 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 amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
    Severity: Moderate
    Configuration: 1- TWIST PP AGC-1 1. High Frequency - Precipitously Sloping; TWIST PR. Flat
    Other: TWIST PP AGC-1 1. Low tolerance To Loudness

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information needed to fill out the table and answer the questions about acceptance criteria and study details. The document is an FDA 510(k) clearance letter for two hearing aid devices (TWIST PP and TWIST PP AGC-1) from 1997. It primarily discusses regulatory classification, substantial equivalence, and general controls, along with a brief section on electromagnetic interference and labeling.

    It does not include:

    • Specific acceptance criteria for device performance (e.g., in terms of sensitivity, specificity, accuracy).
    • Details of any study conducted to prove the device meets acceptance criteria.
    • Information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    The document states that the devices are for "amplifying sound for individuals with impaired hearing" and specifies general indications related to severity (moderate) and configuration (high frequency - precipitously sloping for TWIST PP AGC-1, and flat for TWIST PP) of hearing loss, as well as low tolerance to loudness for TWIST PP AGC-1. However, these are indications for use, not performance acceptance criteria or study results.

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