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510(k) Data Aggregation

    K Number
    K122950
    Device Name
    LASER HELMET
    Manufacturer
    THERADOME INC.
    Date Cleared
    2013-06-14

    (262 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K113097,K091496
    Predicate For
    K132646,K142824,K151516,K161046,K171775,K173729,K181253,K192585
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Theradome Laser Helmet LH80 PRO is an over the counter (OTC)device indicated to treat androgenic alopecia, to Promote hair growth in females with female pattern hair loss (FPHL) on the Ludwig and Savin Hair Loss Scale I-II, Fitzpatrick Skin-Types I to IV:

    Device Description

    The Theradome Laser Helmet LH80 PRO is a low level laser therapy (LLLT) device used to promote hair growth via photobiostimulation. The lasers are contained inside a lightweight, one-size fits all helmet. The LH80 PRO utilizes 80 laser diodes in the helmet to deliver laser stimulation to the entire scalp for hands-free operation during treatment. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the 20 minute treatment completes.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study information provided in the document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document describes two studies related to over-the-counter use for the Theradome Laser Helmet LH80 PRO. These studies are designed to demonstrate the device's appropriateness for consumer use by lay persons, not its clinical effectiveness in treating androgenic alopecia.

    Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device Performance
    Self-Assessment Capability95% of lay persons should be able to correctly self-assess their need for the LH80-PRO based on product labeling.97% of lay persons were able to correctly self-assess their need for the LH80-PRO. (30 out of 31 participants)
    Labeling ComprehensionAn average lay person should be able to read and comprehend the package labeling and instructions correctly.The study concluded that an average lay person can read and comprehend correctly the package labeling and instructions. (Specific percentage not provided, but implies 100% based on the conclusion statement)

    2. Sample Sizes and Data Provenance

    • Test Set Sample Size: For both the "Self-Selection Study" and the "Labeling Comprehension Study," the sample size was 31 participants.
    • Data Provenance: The participants were recruited from the downtown San Francisco commuter train station (Bay Area Rapid Transit - BART) in the USA. The studies appear to be prospective as participants were selected and surveyed specifically for these studies.

    3. Number and Qualifications of Experts for Ground Truth

    • Self-Selection Study:
      • Number of Experts: At least one physician. The text states: "...their hair condition was also examined by a physician who then decided if the person actually had Androgenic Alopecia or not."
      • Qualifications of Experts: A "physician" is mentioned. Specific qualifications (e.g., years of experience, specialization like dermatology) are not provided.
    • Labeling Comprehension Study:
      • Number of Experts: Not applicable, as the ground truth was based on participants' direct answers to questions about their comprehension, verified by study administrators.

    4. Adjudication Method for the Test Set

    • Self-Selection Study: The decision on whether a person actually had Androgenic Alopecia was made by a physician. This implies a single expert's judgment. There's no mention of multiple experts or specific adjudication methods (like 2+1).
    • Labeling Comprehension Study: This study involved participants answering questions, and study administrators evaluating their responses. There's no mention of external experts or adjudication beyond the administrators' assessment of correct comprehension.

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

    No. The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The studies mentioned are focused on user comprehension and self-assessment for OTC use, not clinical effectiveness or human-in-the-loop performance improvement with AI.

    6. Standalone (Algorithm Only) Performance Study

    No. The device is a physical laser helmet, not an algorithm. Therefore, a standalone (algorithm only) performance study as typically understood in the context of AI/software medical devices is not applicable and was not done. The studies focus on user interaction with the device's labeling and its intended OTC use.

    7. Type of Ground Truth Used

    • Self-Selection Study: The ground truth for whether a participant actually had Androgenic Alopecia was established by a physician's examination.
    • Labeling Comprehension Study: The ground truth for correct comprehension was based on participants' answers to specific questions about the labeling, assessed by the study administrators.

    8. Sample Size for the Training Set

    Not applicable. The provided studies are for evaluating consumer comprehension and self-assessment of an over-the-counter device, not for training a machine learning algorithm. Therefore, there is no training set mentioned or implied.

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

    Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.

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