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510(k) Data Aggregation

    K Number
    K113498
    Device Name
    DISPOSABLE TORQUE DEVICE
    Manufacturer
    COEUR, INC.
    Date Cleared
    2012-07-20

    (238 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DISPOSABLE TORQUE DEVICE

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

    to facilitate manipulation of a guide wire during a vascular procedure

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Coeur, Inc. Disposable Torque Device." It's a regulatory approval document and does not contain the information requested in your prompt.

    The prompt asks for details about a study proving a device meets acceptance criteria, including:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size and data provenance for the test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness study details.
    6. Standalone performance study details.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This FDA letter simply states that the device is "substantially equivalent" to legally marketed predicate devices and is approved for marketing. It does not provide any of the study design, acceptance criteria, or performance data that would be found in a clinical or validation study report.

    Therefore, I cannot extract the requested information from the provided text.

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