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510(k) Data Aggregation

    K Number
    K090025

    Validate with FDA (Live)

    Device Name
    MATRIX RF APPLICATOR
    Manufacturer
    SYNERON MEDICAL LTD.
    Date Cleared
    2010-01-08

    (368 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K073572,K052936,K070004
    Predicate For
    K110672,K121150,K180359,K201064
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Matrix RF Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles.

    Device Description

    The Matrix RF Applicator is composed of a connector, cable, handpiece and disposable tips. Treatment using the Matrix RF Applicator is based on delivery of bipolar radio frequency to the skin surface via an array of electrode-pins.

    AI/ML Overview

    The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics in a structured format suitable for the requested table. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with discrete performance metrics against predefined acceptance criteria.

    However, I can extract the information that is present and indicate where certain requested details are missing or not explicitly stated in this document.

    Missing Information:

    • Specific acceptance criteria (e.g., target accuracy, sensitivity, specificity, or changes in wrinkle severity by a specific percentage).
    • Reported device performance against specific metrics (e.g., actual measured reduction in wrinkles, or success rates for ablation/resurfacing).
    • The exact sample size used for any test set (since no explicit study is detailed with performance metrics).
    • Data provenance (country of origin, retrospective/prospective).
    • Number and qualifications of experts for ground truth.
    • Adjudication method for a test set.
    • Whether an MRMC comparative effectiveness study was done.
    • Whether a standalone algorithm performance study was done.
    • The type of ground truth used for performance evaluation.
    • Sample size for a training set.
    • How ground truth for a training set was established.

    Based on the provided text, here is what can be inferred and what remains unknown regarding acceptance criteria and study details:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Implied)Reported Device Performance (Summary)
    New Indication Effectiveness: The device must be effective for additional indications: ablation and resurfacing of the skin for wrinkle treatment."The device was found to be effective for the new indication, supporting the additional indication of the device for ablation and resurfacing of the skin for wrinkle treatment." (No specific quantitative performance metrics are provided).
    Safety: The additional indication should raise no new issues of safety."The overall specifications, principle of operation, performance characteristics of Matrix RF Applicator device have not been changed. Therefore, the additional indication for use of the Matrix RF Applicator device should raise no new issues of safety."
    Substantial Equivalence: Device must be substantially equivalent to predicate devices.The FDA granted 510(k) clearance, indicating substantial equivalence to the predicate devices listed (Matrix RF Applicator K073572, Thermage ThermaCool System K052936, Accent K070004).

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Sample Size: Not specified in this 510(k) summary. The document does not detail a specific clinical study with a test set. It mentions "The device was found to be effective," implying some form of evaluation, but no specifics on patient numbers or methodology are provided.
    • Data Provenance: Not specified.
    • Retrospective/Prospective: Not specified.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not specified. The document does not detail the establishment of a ground truth for a test set in the context of performance metrics.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not specified.

    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

    • Not applicable. This device is a medical applicator for dermatological procedures, not an AI-assisted diagnostic tool that would typically involve human readers.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not applicable. This is a physical device, not an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • Not explicitly stated. Given the claim of "effectiveness for the new indication," it would likely be based on clinical outcomes relevant to wrinkle treatment, ablation, and resurfacing, but the specifics are not provided.

    8. The sample size for the training set

    • Not applicable, as this is a physical device and not an AI algorithm requiring a training set.

    9. How the ground truth for the training set was established

    • Not applicable.
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