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510(k) Data Aggregation

    K Number
    K963519
    Device Name
    EUROLINE A-675 SERIS
    Manufacturer
    STARKEY LABORATORIES, INC.
    Date Cleared
    1996-09-27

    (24 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K960494
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To assist in compensating for hearing loss by amplifying sound as it comes near the ear .

    Device Description

    The Starkey Euroline A•675 Series BTE Hearing aids are behind-the-ear air conduction hearing aids. This form of hearing aid is intended to be received by a Hearing Health Professional in a completed form, not being intended for final assembly.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Euroline A•675 Series hearing aid:

    Based on the provided documents, it is not possible to provide a complete answer to your request. The documents describe the device (Euroline A•675 Series hearing aids) and its substantial equivalence to another device (Starkey A-312 Series BTE Hearing Aids and Euroline A-13 Series BTE hearing aids). However, they contain no information about specific acceptance criteria or any study (clinical or otherwise) that proves the device meets those criteria.

    The text focuses on technical specifications and features, indicating compliance with general standards like ANSI S3.22-1987 and IEC 118-0 1983. However, these are general standards and not specific acceptance criteria linked to a performance study.

    Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

    Here's what can be extracted from the provided text, but it falls short of your request:

    Description of the Device and its Intended Use:

    • NAME OF DEVICES: A•675 TSP, A•675 Sequel
    • TYPE OF DEVICE: Air Conduction Behind-the-Ear hearing aids
    • INTENDED USE: To assist in compensating for hearing loss by amplifying sound as it comes near the ear.
    • TECHNICAL CHARACTERISTICS: Technical specifications comply with ANSI S3.22-1987 and IEC 118-0 1983. (This is the closest to a "standard" or "criteria" mentioned, but it's a general compliance statement, not performance-based acceptance criteria from a study).

    Summary of missing information directly related to your request:

    • Specific Acceptance Criteria: Not defined.
    • Reported Device Performance against Acceptance Criteria: Not provided.
    • Study Details (test set sample size, data provenance, number of experts, adjudication, MRMC, standalone performance, ground truth type, training set sample size, ground truth establishment for training set): None of this information is available in the provided text.

    It appears the provided documents are likely part of a regulatory submission primarily focused on demonstrating substantial equivalence to a predicate device based on features and technical specifications, rather than a detailed report of a performance study with explicit acceptance criteria.

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