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510(k) Data Aggregation

    K Number
    K162450
    Device Name
    ESPADA Acne-Clearing Blue Light Pen
    Manufacturer
    FOREO INC.
    Date Cleared
    2016-11-30

    (90 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ESPADA Acne-Clearing Blue Light Pen

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

    The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.

    Device Description

    Not Found

    AI/ML Overview

    This PDF does not contain the detailed study information required to answer your request regarding acceptance criteria and device performance for the Espada Acne-clearing Blue Light Pen. The document is an FDA 510(k) clearance letter, which states that the device is substantially equivalent to a legally marketed predicate device. It does not include specific clinical study results, acceptance criteria, or performance data that would typically be found in a clinical trial report or a more detailed submission.

    Therefore, I cannot provide the following information from the given text:

    1. A table of acceptance criteria and the reported device performance: This information is not present.
    2. Sample size used for the test set and the data provenance: Not available.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
    4. Adjudication method for the test set: Not available.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not available. This is also for an AI device, and the Espada Pen is a light therapy device.
    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not available. Again, this is for an AI device.
    7. The type of ground truth used: Not available.
    8. The sample size for the training set: Not available.
    9. How the ground truth for the training set was established: Not available.

    The document primarily focuses on the regulatory clearance of the device based on substantial equivalence. To find the acceptance criteria and study details, you would typically need to consult the original 510(k) submission summary or a clinical study report if one was conducted and made public.

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