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510(k) Data Aggregation

    K Number
    K050342
    Device Name
    THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM
    Manufacturer
    THERALASE INC.
    Date Cleared
    2005-07-11

    (150 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K072551,K081166
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Theralase™ TLC-1000 Therapeutic Medical Laser System is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.

    Device Description

    The Theralase™ TLC-1000 Therapeutic Medical Laser System is a non-heating infrared lamp as defined in 21 CFR 890.5500. The TLC-1000 system is a precision medical device as wontion of a hand held portable multiple laser probe (5 x 905 NIR laser diodes and 4 x 660 visible red laser diodes) and a laser controller unit with a rechargeable battery.

    AI/ML Overview

    Acceptance Criteria and Device Performance for Theralase™ TLC-1000 Therapeutic Medical Laser System

    1. Table of Acceptance Criteria and Reported Device Performance

    MetricAcceptance Criteria (Implied)Reported Device Performance
    Efficacy (Pain Relief)Statistically significant difference in pain reduction (VAO scores) between active laser and sham laser groups.p-value < 0.05 at 12th treatment session; p-value < 0.01 at 30-day post-treatment follow-up. This indicates a statistically significant improvement in pain relief for the active laser group compared to the sham group.
    Responder Rate (Active Laser)High percentage of subjects in the active laser group experiencing a positive response (likely defined as significant pain reduction).92.4% responder rate for the "Active" Laser group at the end of laser treatment sessions and 30-day follow-up.
    SafetyNo significant adverse effects observed due to laser treatment.No adverse effects from the laser treatments were observed by the principal investigators during the clinical investigational study.

    Study Proving Device Meets Acceptance Criteria:

    The Theralase™ TLC-1000 Therapeutic Medical Laser System's performance was evaluated in a prospective, single-blind, randomized, controlled multi-center clinical study.

    2. Sample Size and Data Provenance:

    • Sample Size for Test Set: A total of 122 adult male and female subjects were enrolled in the study.
    • Data Provenance: The study was conducted at three investigational sites in the United States of America, making the data provenance prospective and multi-country (specifically, U.S. based).

    3. Number of Experts and Qualifications for Ground Truth:

    The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for assessing individual subject pain levels. However, it indicates:

    • Diagnosis of Knee pain for 6 years and older with a pain level of at least 4 as measured by a Visual Analog Scale (VAS). This implies that pain levels were assessed by healthcare professionals.
    • Failed conservative therapy by a Physician, Orthopedist, or Chiropractor. This indicates that the inclusion criteria for subjects, and therefore the determination of their initial condition, involved qualified medical professionals.

    Given the study design, the "ground truth" for individual pain relief would likely be derived from the patient-reported Visual Analog Scale (VAS) scores, which are a direct measure of the patient's subjective experience of pain.

    4. Adjudication Method for the Test Set:

    The study was described as single-blind. This means that the subjects were blinded to whether they received the active laser or the sham laser. It does not explicitly state any independent adjudication method for individual cases or outcomes beyond the statistical analysis of the collected VAS scores.

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

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device does not involve image interpretation or diagnostic tasks that would typically utilize such a study design. The study focuses on direct therapeutic effect (pain relief).

    6. Standalone (Algorithm Only) Performance:

    No, a standalone (algorithm only) performance study was not performed. This device is a therapeutic laser system, not an AI algorithm. Its performance is directly tied to its physical application by a healthcare professional to a patient.

    7. Type of Ground Truth Used:

    The primary ground truth used was patient-reported outcomes, specifically Visual Analog Scale (VAS) scores for pain relief. The study also used clinical diagnosis by medical professionals (Physician, Orthopedist, or Chiropractor) for subject inclusion criteria (e.g., diagnosis of knee pain, failure of conservative therapy).

    8. Sample Size for the Training Set:

    N/A. This device is a medical device, not an AI algorithm that requires a training set in the typical machine learning sense. The study described is a clinical trial to evaluate the device's efficacy and safety in human subjects, not to train a model.

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

    N/A. As mentioned above, there is no "training set" in the context of this device. The clinical study serves as the evidence for its effectiveness, rather than data used to train an algorithm.

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