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510(k) Data Aggregation

    K Number
    K043017
    Device Name
    PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2005-03-08

    (126 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Medline Prevention ™ Disposable Surgical Gowns are surgical apparel that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of body fluids, micro-organisms, and particulate material.

    Device Description

    Medline Prevention Surgical Gowns

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to Medline Industries, Incorporated, regarding their "Medline Prevention Surgical Gowns." This type of document is a regulatory approval, not a description of a study proving device performance against acceptance criteria.

    The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device is considered as safe and effective as a device already on the market, but it does not include information about a specific study with acceptance criteria and a detailed analysis of device performance.

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria based solely on the provided text. The document does not contain:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts to establish ground truth.
    4. Adjudication methods.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Information about a standalone algorithm performance study.
    7. The type of ground truth used.
    8. Sample size for a training set.
    9. How ground truth for a training set was established.

    This document is solely focused on the regulatory approval process through the 510(k) pathway, which relies on demonstrating substantial equivalence, often through comparisons to an existing predicate device's performance, rather than providing raw study data or acceptance criteria for a new, independent performance study.

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