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510(k) Data Aggregation

    K Number
    K970900
    Device Name
    INSTRUMENT HOLDER
    Manufacturer
    CONTOUR FABRICATORS, INC.
    Date Cleared
    1997-05-22

    (72 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K940891
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The disposable, sterile instrument holder is intended to be an easily positioned sterile support for surgical instruments. Pressure sensitive adhesive strips are included to allow easy application of the holder to a dry operating room surface.

    Examples of possible instruments held by this device are lightweight microsurgical instruments, bipolar forceps, or suction tube tips.

    Device Description

    The sterile, disposable instrument holder is made of 8 mil vinyl. The overall dimensions of the device are 7.25" x 8.5". The vinyl is heat sealed to create 6 pockets to allow for easy instrument storage and retrieval. Pocket sizes are as follows: (1) pocket at 4"x3.75", (1) pocket at 4"x6", (2) pockets at 2"x3.75", (2) pockets at 2"x6"

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for a medical device (an Instrument Holder) and a letter from the FDA confirming its substantial equivalence to a predicate device.

    The 510(k) summary describes the device, its intended use, and identifies a predicate device. The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate and can therefore be marketed. This process primarily focuses on demonstrating equivalence to an existing device rather than on presenting performance data against detailed acceptance criteria in the way a clinical study for a novel or riskier device might.

    Therefore, I cannot provide the requested information, including:

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

    This is because the provided text does not contain any details about performance testing, clinical studies, or acceptance criteria related to a study.

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