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510(k) Data Aggregation

    K Number
    K173337
    Device Name
    Intuitive Surgical EndoWrist Vessel Sealer Extend
    Manufacturer
    Intuitive Surgical, Inc.
    Date Cleared
    2018-04-26

    (185 days)

    Product Code
    NAY
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K170865
    Predicate For
    K183107
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EndoWrist Vessel Sealer Extend is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist Vessel Sealer Extend has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

    Device Description

    The EndoWrist Vessel Sealer Extend is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing and an Erbe VIO dV generator. The EndoWrist Vessel Sealer Extend device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to a compatible da Vinci Surgical System. An integrated cord attached to the housing is connected to a receptacle in the IESU. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the compatible da Vinci Surgical System foot pedals.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves a device meets specific acceptance criteria in the context of AI/ML performance. The document is a 510(k) summary for the "Intuitive Surgical EndoWrist Vessel Sealer Extend," a surgical instrument, and primarily discusses its substantial equivalence to a predicate device, its intended use, and various types of performance testing (bench testing, animal/cadaver studies, and a chronic animal study).

    Therefore, I cannot provide the requested table or answer the specific questions related to acceptance criteria, AI/ML performance, sample sizes for test/training sets, expert qualifications, or ground truth establishment.

    The document focuses on the safety and effectiveness of a physical surgical instrument, not on software performance or diagnostic/prognostic capabilities involving AI.

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