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510(k) Data Aggregation

    K Number
    K060883
    Device Name
    PILOT TEST OR DETECTIVE AUDIOMETERS
    Manufacturer
    INTERACOUSTICS A/S
    Date Cleared
    2006-06-23

    (84 days)

    Product Code
    EWO,GWJ
    Regulation Number
    874.1050
    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 Pilot Test and Detective audiometers are both manual single channel pure tone air conduction audiometers used to test the hearing thresholds of children.

    The Pilot Test audiometer has the additional capability of using speech testing using "select picture" audiometry with Spondee word lists.

    The Detective audiometer has the additional capability to perform automatic pure-tone audiometry.

    Device Description

    manual single channel pure tone air conduction audiometers

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for two audiometers, "Pilot Test" and "Detective." It primarily addresses the regulatory approval of the devices based on substantial equivalence to existing predicate devices.

    The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval notice, not a technical performance report or a clinical study summary.

    Therefore, requested information regarding device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results cannot be extracted from this document.

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