LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K964669
    Device Name
    MIRACLE-EAR OR AUDIOTONE
    Manufacturer
    MIRACLE-EAR, INC.
    Date Cleared
    1996-12-26

    (35 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K926092
    Why did this record match?
    Device Name :

    MIRACLE-EAR OR AUDIOTONE

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

    To amplify and transmit sound to the ear.

    Device Description

    Dahlberg Power BTE

    AI/ML Overview

    Based on the provided document and the nature of the device (a BTE Hearing Aid), this information does not contain the details necessary to answer your request.

    Here's why and what's missing:

    • Acceptance Criteria & Reported Device Performance: The document provides general characteristics of the device (device type, intended use, materials, assembly, power, fit). It states that Dahlberg "utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." However, it does not list specific acceptance criteria (e.g., minimum gain, maximum output, frequency response within a certain tolerance, distortion levels) or report any specific performance data against such criteria. For example, it doesn't say "Gain at 1000 Hz: 40 dB, Acceptance Criteria: 38-42 dB."

    • Study That Proves the Device Meets Acceptance Criteria: Since no specific acceptance criteria or performance data are provided, there is also no description of a study that proves the device meets these criteria. The mention of "ANSI S3.22-1987 methodology" indicates a standardized testing method is used, but not the results or the study design for demonstrating compliance.

    Therefore, I cannot populate the table or provide the requested information regarding sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in detailed performance reports, clinical study summaries, or validation protocols, which are not present in this "Summary of Safety and Effectiveness" document for a K964669 submission.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1