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510(k) Data Aggregation

    K Number
    K984355
    Device Name
    POINT SETTER
    Manufacturer
    MITAKA USA, INC.
    Date Cleared
    1999-04-01

    (115 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K090792
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The point setter is indicated for use as a holder for an endoscope.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a device called "Point Setter Endoscope Holder." It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

    • A table of acceptance criteria or reported device performance.
    • Sample sizes for test sets or data provenance.
    • Number of experts or their qualifications for establishing ground truth.
    • Adjudication methods.
    • Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Results of a standalone (algorithm only) performance study.
    • Types of ground truth used.
    • Sample size for a training set.
    • How ground truth for a training set was established.

    This is a regulatory clearance document, not a scientific study or technical report detailing performance testing.

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