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510(k) Data Aggregation

    K Number
    K230013
    Device Name
    Silk'n Titan Allways
    Manufacturer
    Silk'n Beauty Ltd.
    Date Cleared
    2023-08-30

    (239 days)

    Product Code
    PAY,OHS
    Regulation Number
    878.4420
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K162784
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Silk'n Titan AllWays is an over-the-counter home use device intended for the non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick skin types I-IV.

    Device Description

    The Silk'n Titan AllWays is a cordless, hand-held device, utilizing RF energy and low power light spectrum. The device includes an RF generator, an array of 8 LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths respectively), and a temperature stabilizer. The Silk'n Titan AllWays consists of an applicator and an adaptor. The hand-held applicator delivers energy from the treatment surface at the applicator tip which comes in direct contact with the skin. The applicator is equipped with an ON/OFF switch (that also selects the energy level) and an indicators panel. The device can be powered by an internal rechargeable battery (cordless mode) or with the AC adaptor that connects the applicator to an electrical outlet.

    AI/ML Overview

    The provided text describes the regulatory clearance for the Silk'n Titan AllWays device but does not present specific acceptance criteria or an explicit "study that proves the device meets the acceptance criteria" in the format typically used for performance claims. Instead, it outlines non-clinical performance testing and a clinical study to demonstrate safety and effectiveness for its intended use, which is the non-invasive treatment of mild to moderate facial wrinkles.

    Here's an attempt to extract the information requested, interpreting "acceptance criteria" as general performance goals implied by the clinical study and the "study that proves the device meets the acceptance criteria" as the clinical trial described.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied from Clinical Study Goals)Reported Device Performance (Clinical Study Results)
    Non-invasive treatment of mild to moderate facial wrinkles.Statistically significant average reduction of 1.39 Fitzpatrick scores comparing baseline to 3-month follow-up (p < 0.001).
    Improvement in wrinkle severity.Improvement of at least 1 score according to the Fitzpatrick Wrinkle and Elastosis scale for most patients.
    Safety acceptable for home use.No unexpected adverse events detected. Treatment associated with mild to no pain.
    Device is easy and safe to operate by end-users.Usability parameters tested indicated the device is easy and safe to operate. Separate Usability Study confirmed labeling comprehension, user operation, and safety under actual use conditions.
    Skin temperature does not exceed safe values.Thermal testing in a human volunteer showed worst-case energy and power deposition is not likely to raise skin temperature above safe, acceptable values.

    2. Sample size used for the test set and the data provenance

    • Test Set Sample Size: 32 eligible adult women for the clinical study.
    • Data Provenance: The clinical study was conducted at a certified clinic in the US. It is a prospective clinical study specifically designed for this submission.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Number of Experts: 3 blinded evaluators.
    • Qualifications of Experts: The document does not explicitly state the qualifications (e.g., radiologist, dermatologist, years of experience) of the "3 blinded evaluators" directly, but given the context of facial wrinkle assessment in a clinical study for a medical device, it is highly probable they were experienced clinicians or dermatologists.

    4. Adjudication method for the test set

    • The document implies that the "3 blinded evaluators" independently assessed the Fitzpatrick scores. It states, "...as determined by 3 blinded evaluators." It doesn't specify an adjudication method like 2+1 or 3+1 if there was disagreement, but rather that the result was "determined by" them cumulatively.

    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 MRMC comparative effectiveness study was done involving AI assistance. This device is a direct treatment device (RF energy and LED light), not an AI diagnostic or assistance tool for human readers. The clinical study evaluated the direct effect of the device on wrinkle reduction.

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

    • Not applicable. This is a hardware device for direct treatment, not an algorithm. The clinical study assessed the device's performance standalone in human subjects.

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

    • Expert assessment/consensus: The reduction in Fitzpatrick scores and improvement based on the Fitzpatrick Wrinkle and Elastosis scale were determined by "3 blinded evaluators." This constitutes expert assessment, likely aiming for consensus or an average.

    8. The sample size for the training set

    • Not applicable. This device is a direct treatment device, not an AI model that requires a "training set."

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

    • Not applicable. (See point 8).
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