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    K Number
    K120775
    Device Name
    LIGHT FOR WRINKLES
    Manufacturer
    LED INTELLECTUAL PROPERTIES, LLC
    Date Cleared
    2012-06-04

    (82 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K120775,K101190
    Why did this record match?
    Device Name :

    LIGHT FOR WRINKLES

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

    The LightStim for Wrinkles is an over-the-counter hand-held device intended for the use in the treatment of full-face wrinkles

    Device Description

    The LightStim for Wrinkles is a hand-held device with a power output of 65mW/cm2, consisting of light emitting diodes (LED's) that emit Low and Sub IR light for direct exposure to the skin. The components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelength, a (non-flammable plastic) hand piece housing, a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with a resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC (9-volt) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information for the LightStim for Wrinkles K120775, based on the provided text:

    Acceptance Criteria and Device Performance

    The provided document describes two main types of studies used for the LightStim for Wrinkles (K120775) to establish substantial equivalence to its predicate device (Light for Wrinkles K101190): a Usability Study and a Clinical Study. The acceptance criteria are implicitly tied to demonstrating similar performance to the predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Criteria / GoalReported Device Performance (LightStim for Wrinkles K120775)
    Usability Study1. Attract intended users.All four goals of the Study were met.
    2. Consumers could self-select device using packaging.All four goals of the Study were met.
    3. Consumers knowledge of packaging/manual.All four goals of the Study were met.
    4. Consumers demonstrate ability to operate/care for device correctly.All four goals of the Study were met. Indicating similar consumer usability to the predicate device.
    Clinical StudyReduction in full-face wrinkles (measured by Fitzpatrick Wrinkle Scale - FWS).- Baseline FWS: 5.73
    • After 8 weeks: 4.54
    • 3-month follow-up: 4.2
      This shows an average reduction in full-face wrinkles. The study's premise was to deliver similar results in full-face wrinkle reduction as the predicate device did for periorbital wrinkles, implying the magnitude of reduction or the percentage of participants showing reduction (100% for the predicate) was the implicit criterion. The document states it produced "similar results." |

    2. Sample Size and Data Provenance

    • Test Set (Clinical Study): 40 participants
    • Data Provenance: The document does not explicitly state the country of origin. It indicates it was an 8-week Clinical Study and a 3-month follow-up, suggesting a prospective study design.

    3. Number of Experts and Qualifications for Ground Truth

    • The clinical study utilized the Fitzpatrick Wrinkle Scale (FWS) to judge wrinkle severity. The specific number of experts or their qualifications for assessing the FWS scores are not mentioned in the provided text. It is implied that trained personnel would have applied this scale, but no details are given.

    4. Adjudication Method for the Test Set

    • The document does not specify any adjudication method for the Fitzpatrick Wrinkle Scale assessments.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in the provided text. The study focused on the device's efficacy on participants rather than comparing human readers' performance with and without AI assistance.

    6. Standalone Performance Study

    • Yes, a standalone clinical study was performed to assess the device's effectiveness in reducing full-face wrinkles without human-in-the-loop assistance (beyond what's inherent in user-operated devices). The results (FWS reduction) demonstrate the algorithm's (or device's) standalone impact.

    7. Type of Ground Truth Used

    • The ground truth used for the clinical study was based on the Fitzpatrick Wrinkle Scale (FWS) scores, which are a standardized assessment of wrinkle severity. This is a form of expert assessment or clinical measurement.

    8. Sample Size for the Training Set

    • The provided text does not mention a "training set" in the context of an algorithm or AI. This device is a light-emitting device, not an AI/software device that would typically have a training set for an algorithm. The clinical study participants (40 individuals) serve as the test set for the device's performance.

    9. How Ground Truth for the Training Set Was Established

    • As the device is not an AI/software device that uses a "training set" in the conventional sense, this question is not applicable based on the provided information. The 40 participants in the clinical study are the "test set" to prove the device's efficacy, and their wrinkle severity was assessed using the FWS scale.
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