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510(k) Data Aggregation

    K Number
    K140255
    Device Name
    STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA)
    Manufacturer
    POLLOGEN LTD
    Date Cleared
    2014-05-14

    (103 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K111026
    Predicate For
    K182774,K231146
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Pollogen's STOP U is intended for use in the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

    Device Description

    The STOP™ U device delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers.

    The device consists of the following components and accessories: The STOP U device (applicator unit), the STOP U Power Supply and the STOP Preparation Gel.

    AI/ML Overview

    Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from text)Reported Device Performance (from text)
    Electrical Verification: Validate power control and accuracy."STOP U Electrical Verification was done to validate the STOP U power control and accuracy in reference to the user's input. In all instances, the STOP U system functioned as intended and observations were as expected."
    Software Validation: Ensure software functions as required."The STOP U software was validated as required. In all instances, the STOP U system functioned as intended and observations were as expected."
    Safety and Efficacy for Wrinkle Treatment: Evaluate safety and efficacy for treating mild to moderate facial wrinkles and rhytides."Over 80% of the subjects showed at least one grade improvement in Fitzpatrick wrinkle score at three months follow-up post treatment based on objective evaluations of the baseline and three months follow-up photographs. There were no incidences of adverse effects or complications. As expected, mild to moderate erytherna and mild edema were detected at the site of treatment immediately after treatment. All cases resolved without treatment within few hours. Treatment was well tolerated with minimal to no pain in the majority of study subjects. The data reported in this study clearly indicates that the Stop U provides a safe and effective treatment for facial wrinkles."
    Compliance with Performance Standards:
    - EN/IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, Collateral Standard: Safety Requirements for Medical Electrical Systems."The STOP U system complies with the following performance standards..." (Implicitly, the successful operation implies compliance).
    - EN/IEC 60601-1-2 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic Compatibility - Requirements and Tests."The STOP U system complies with the following performance standards..."
    - EN/IEC 60601-2-2 Safety of high frequency surgical equipment."The STOP U system complies with the following performance standards..."

    2. Sample Size Used for the Test Set and the Data Provenance

    • Sample Size: 40 subjects were enrolled in the study.
    • Data Provenance: The document does not explicitly state the country of origin. The study was a "study" which implies it was specifically conducted for this purpose. The timing of follow-up (3 months post last treatment) suggests it was a prospective study.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

    • Number of Experts: Three uninvolved physicians.
    • Qualifications of Experts: Not specified beyond "uninvolved physicians." We do not know their specialty (e.g., dermatologists, plastic surgeons) or years of experience.

    4. Adjudication Method for the Test Set

    • Adjudication Method: The ground truth was established by the "blinded evaluation" of pre and post-treatment photos by three uninvolved physicians using the Fitzpatrick Wrinkle and Elastosis scale. It is unclear if a consensus was required or how discrepancies were handled (e.g., simple majority, all three agreeing).

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

    • No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not done. This study is a clinical efficacy trial of the device itself, not an evaluation of an AI component aiding human readers.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • No, a standalone (algorithm only) performance study was not done. This device is an electrosurgical system, not an AI diagnostic algorithm. The "objective evaluations" based on photographs by physicians are part of the clinical study, not a standalone algorithm evaluation.

    7. The Type of Ground Truth Used

    • The ground truth for the efficacy assessment was expert consensus (three uninvolved physicians) based on photographic evaluation using the Fitzpatrick Wrinkle and Elastosis scale.

    8. The Sample Size for the Training Set

    • Not applicable. This device is a physical electrosurgical system, not a software algorithm that requires a training set in the AI sense.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable, as there is no training set in the AI sense for this device.
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