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510(k) Data Aggregation

    K Number
    K011755
    Device Name
    STRYKER T4 HYTREL (R) TOGAS
    Manufacturer
    STRYKER CORP.
    Date Cleared
    2001-06-22

    (16 days)

    Product Code
    LYU
    Regulation Number
    878.4040
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STRYKER T4 HYTREL (R) TOGAS

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

    The Stryker Hytrel® Zippered Toga and Pull-over Toga are components of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

    Device Description

    The Stryker T4 Personal Protection System: Stryker Hytrel® T4 Togas.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any study details. The document is an FDA 510(k) clearance letter for the Stryker T4 Hytrel® Togas, indicating that the device is substantially equivalent to a legally marketed predicate device. It defines the product and its intended use but does not contain any data from performance studies.

    Therefore, I cannot fulfill your request for:

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