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    K Number
    K101321
    Device Name
    EMATRIX CO2
    Manufacturer
    SYNERON MEDICAL LTD.
    Date Cleared
    2010-11-09

    (182 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K071051,K072182,K080463
    Why did this record match?
    Device Name :

    EMATRIX CO2

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

    Dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.

    Device Description

    The eMatrix CO2 is a Fractional CO2 laser device intended for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue including skin. The device console houses the major units of the system that include the laser module, the power supply, the scanner and all other electrical components. Laser is transmitted to the tissue via a series of lens integrated into the articulated arm. The system parameters are controlled via a LCD touchscreen and proprietary SW.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the performance evaluation of the eMatrix CO2 device.

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state quantitative acceptance criteria in a numerical format often seen for diagnostic devices (e.g., sensitivity, specificity thresholds). Instead, the performance evaluation focuses on the device's ability to achieve its intended physical effects on tissue.

    Acceptance Criteria (Implied)Reported Device Performance
    Device produces morphological changes consistent with ablation, coagulation, and resurfacing of soft tissue, including skin.Performance Evaluation of skin biopsies revealed morphological changes, which were created under the impact of the eMatrix CO2 of skin resurfacing, as expressed via demarcated zones of ablation and coagulation.
    Device demonstrates different impacts in depth and width based on treatment modes.The different treatment modes led to a different impact in depth and width of the tissue.
    Affected zones become deeper with increased energy levels.The affected zones tended to become deeper as the level of energy employed was increased.
    Device maintains a uniform fractional phenotype, leaving intact, non-affected tissue between treated spots.The affected zone were of uniform fractional phenotype, leaving intact, non-affected tissue between treated spots.
    Device meets labeled performance claims and is substantially equivalent to predicate devices.Conclusion: We have demonstrated that the eMatrix CO2 meets its labeled performance claims, and that it is substantially equivalent to the predicate devices. (This is a summary statement based on the qualitative findings described above and comparison to predicates.)

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

    • Sample Size: The document only mentions "skin biopsies" being evaluated. It does not provide an explicit numerical sample size for the test set (e.g., number of biopsies, number of subjects).
    • Data Provenance: Not specified in the provided text. It does not mention the country of origin of the data or whether the study was retrospective or prospective.

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

    • The document does not specify the number of experts used or their qualifications for establishing ground truth. The evaluation mentions "morphological changes, which were created under the impact of the eMatrix CO2," implying a direct observation of the physical effects on tissue, likely by pathologists or histologists.

    4. Adjudication Method for the Test Set

    • The document does not describe any adjudication method (e.g., 2+1, 3+1). The evaluation appears to be a direct physical assessment of biopsy results.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    • No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is more common for diagnostic imaging devices where human readers interpret results. The eMatrix CO2 is a therapeutic laser device, and its performance evaluation focused on its direct physical effects on tissue.

    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 conducted. The eMatrix CO2 is a physical medical device, not a software algorithm, so this type of study isn't applicable.

    7. The Type of Ground Truth Used

    • The ground truth used was based on histopathological examination of skin biopsies. The "morphological changes" and "demarcated zones of ablation and coagulation" observed in the biopsies served as the direct evidence (ground truth) of the device's effect.

    8. The Sample Size for the Training Set

    • The document describes a "Performance Evaluation of skin biopsies" which appears to be the primary study for demonstrating performance. There is no mention of a separate training set or any machine learning/AI component that would require one. The validation is based on the direct physical outcomes on the test biopsies.

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

    • As there is no mention of a training set for a machine learning model, this question is not applicable. The "ground truth" (histopathological observations) was established for the performance evaluation biopsies directly.
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