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510(k) Data Aggregation

    K Number
    K023111
    Device Name
    GYRUS PLASMA SKIN RESURFACING SYSTEM
    Manufacturer
    GYRUS MEDICAL, INC.
    Date Cleared
    2003-03-13

    (175 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K992180,K013639,K974789
    Predicate For
    K041999
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:

    • Superficial skin lesions .
    • . Actinic Keratosis
    • Viral papillomata ●
    • . Sceborrhoeic Keratosis

    The-system-is-intended-for-use-by-qualified-medical-personal-trained in-the-use-ofelectrosurgical equipment.

    Device Description

    The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:

    • Superficial skin lesions .
    • Actinic Keratosis
    • Viral papillomata ●
    • Sceborrhoeic Keratosis .

    Accessories included with the generator are a cable assembly/instrument, power cable and a footswitch.

    AI/ML Overview

    This 510(k) summary does not contain the information requested for acceptance criteria and a study proving the device meets those criteria.

    Here's why and what information is missing:

    • No Acceptance Criteria or Performance Data Presented: The document describes the device, its intended use, and states it has been compared to predicate devices with "performance validation testing" done. However, it does not explicitly state any quantitative acceptance criteria for the device's performance, nor does it present any specific results from such validation testing in the summary provided.
    • No Study Details: Without stated acceptance criteria and performance results, there is no study described that demonstrates the device meets these criteria. All of the specific points requested (sample size, data provenance, expert input, adjudication, MRMC, standalone, ground truth, training set details) are entirely absent because no study details are provided.

    Based on the provided text, I cannot complete the requested tables and information. The document primarily focuses on:

    • Identification of the device and manufacturer.
    • Intended use and comparison to predicate devices.
    • FDA's determination of substantial equivalence (without detailing how that equivalence was proven regarding performance metrics).

    To answer your request, a document detailing the specific performance validation study, including its design, outcomes, and the acceptance criteria measured against, would be required.

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