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510(k) Data Aggregation

    K Number
    K020736
    Device Name
    TRAATEK COTTONOID PATTIES
    Manufacturer
    TRAATEK, INC.
    Date Cleared
    2002-06-03

    (89 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRAATEK, INC.

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

    To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Traatek Cottonoid Patties." This document describes the regulatory approval of a medical device, specifically traditional cottonoid patties, based on its "substantial equivalence" to legally marketed predicate devices.

    Critical Note: The information provided is for a traditional, physical medical device (cottonoid patties) and does not contain any details about an AI/ML-based device or a study proving its performance against specific acceptance criteria in the manner requested by the prompt. The prompt's questions are tailored for AI/ML device evaluations (e.g., sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance).

    Therefore, I cannot provide the requested information from the given text. The FDA letter is a regulatory approval for a conventional medical product, not an AI/ML diagnostic or therapeutic system.

    To answer your prompt, I would need a regulatory document or scientific publication detailing the development and validation of an AI/ML device, including performance metrics, study design, and ground truth methodologies.

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