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510(k) Data Aggregation

    K Number
    K992460
    Device Name
    CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY
    Manufacturer
    STARION INSTRUMENTS
    Date Cleared
    1999-10-05

    (74 days)

    Product Code
    GEI,HQP
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Simultaneous cutting and cauterization of soft tissue during surgery.

    Device Description

    The Cautery Clamp, a hand-held surgical instrument, is powered by a disposable Battery Pack Power Supply. The Cautery Clamp consists of two components that are sold separately: a reusable Surgical Clamp, and a disposable Clamp Insert with power cord. The Cautery Pack Power Supply is intended for the simultaneous cutting and cauterization of soft tissue during surgery, to be used in essentially all major surgical disciplines.

    AI/ML Overview

    This looks like a 510(k) premarket notification for a medical device. Unfortunately, the provided text does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The document is a summary describing the device (a thermal cautery clamp), its intended use, and its substantial equivalence to a predicate device. It also includes the FDA's letter of clearance.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and performance studies based on the provided text. To answer your questions, I would need a different document, such as a test report, clinical study summary, or a more detailed section of the 510(k) submission that discusses performance data.

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