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510(k) Data Aggregation

    K Number
    K063639
    Device Name
    AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1
    Manufacturer
    TISSUELINK MEDICAL, INC.
    Date Cleared
    2007-02-22

    (77 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TissueLink SS4.0 bipolar sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein-sealling during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)

    Device Description

    Aquamantys SS4.0 Bipolar Sealer

    AI/ML Overview

    This document is a 510(k) Summary of Safety and Effectiveness for the TissueLink Aquamantys SS4.0 Bipolar Sealer and an FDA clearance letter. It describes the device and its intended uses, and claims substantial equivalence to a predicate device.

    However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

    Therefore, I cannot fulfill the request for the following information:

    • A table of acceptance criteria and the reported device performance
    • Sample size used for the test set and the data provenance
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    • Adjudication method for the test set
    • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
    • If a standalone performance study was done
    • The type of ground truth used
    • The sample size for the training set
    • How the ground truth for the training set was established

    This type of information is typically found in a clinical study report or a more detailed section of a 510(k) submission, not in the summary provided. The 510(k) summary focuses on demonstrating substantial equivalence based on indications for use, technological characteristics, and safety and effectiveness, often by comparison to a predicate device rather than presenting new clinical study data with acceptance criteria for a new device.

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