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510(k) Data Aggregation

    K Number
    K021402
    Device Name
    THERMAGE THERMACOOL TC SYSTEM
    Manufacturer
    THERMAGE, INC.
    Date Cleared
    2002-11-05

    (187 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K000944,K003183,K013639
    Predicate For
    K030142,K031046,K032088,K033942,K040135,K043402,K060948
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Thermage ThermaCool TC System (Model TC) is indicated for use in:

    Dermatologic and general surgical procedures for electrocoagulation and hemostasis,

    Non-invasive treatment of periorbital wrinkles and rhytids

    Device Description

    The Thermage ThermaCool TC System consists of the following components:

    • RF Generator
    • Cooling Module
    • Cryogen Canister
    • Handpiece Assembly (consisting of Handpiece and Treatment Tip)
    • Accessory cables and tubing
    • Optional footswitch component
    • Accessories: coupling fluid, return pad and skin marking paper

    The Handpiece Assembly and Cooling Module connect to the RF Generator.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, or any studies conducted to prove that the device meets specific criteria.

    The document provided is a 510(k) premarket notification summary for the Thermage ThermaCool TC System. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. It also includes the FDA's clearance letter.

    This type of document typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance acceptance criteria and study results in the manner you described for an AI/ML device. The "technological characteristics and clinical use data" mentioned are used to establish substantial equivalence to predicate devices, but the specifics of any performance evaluations or clinical trials for this particular device (beyond what's needed for the 510(k) process) are not detailed in this excerpt.

    Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance or details about study design elements like sample size, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth sources, or training set information.

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