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510(k) Data Aggregation

    K Number
    K082969
    Device Name
    LUMINEX INFRARED LAMP SYSTEM
    Manufacturer
    MEDICAL LASER SYSTEMS INC
    Date Cleared
    2008-10-23

    (17 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K033923,K053473,K040662
    Predicate For
    K123177
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Luminex Infrared Lamp System is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

    Device Description

    The Luminex Infrared Lamp System is an AC operated, non-invasive, therapeutic medical device that provides continuous heat therapy through the use of infrared and visible laser diodes. The system consists of a Control Unit that houses the electronics and controls, and treatment probes that contain the infrared and visible laser diodes. The probes are intended to be placed directly on the skin to provide topical heating.

    AI/ML Overview

    The provided text describes the Luminex Infrared Lamp System, a therapeutic medical device, and its 510(k) premarket notification. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the format requested.

    The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. The "Testing" section broadly mentions "functional performance testing and electrical safety testing in accordance with all applicable standards for Infrared Lamp Systems of this type," but it does not elaborate on what these tests entailed, what the acceptance criteria were, or the performance results.

    Therefore, much of the requested information regarding sample sizes, ground truth establishment, expert adjudication, or MRMC studies cannot be extracted from this document as these types of detailed studies were not presented.

    Here's an attempt to answer the questions based on the available information, with many points noted as "Not Provided" due to the nature of the document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device Performance
    Functional PerformanceProduct produces a level of tissue temperature reported in the literature and accepted by the FDA for therapeutic heat.Performs as intended, producing a level of tissue temperature reported in the literature and accepted by the Federal Food and Drug Administration.
    Electrical SafetyIn accordance with all applicable standards for Infrared Lamp Systems of this type.Tested in accordance with all applicable standards.
    Intended UseEquivalent to predicate devices (Thor DDII IR Lamp System, Maestro MDTL Laser System, Vectra Genisys Laser System).Has the equivalent intended uses.
    Technical & Performance CharacteristicsSimilar to predicate devices.Has similar technical and performance characteristics.
    Safety & Efficacy IssuesDevice does not raise any new safety or efficacy issues.Does not raise any new safety or efficacy issues.

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

    • Sample size: Not Provided (The document mentions "functional performance testing" and "electrical safety testing" but does not specify the number of devices tested or any patient/subject data if applicable).
    • Data provenance: Not Provided (No patient data or human subject studies are detailed. The testing appears to be primarily device-centric and in-house.)

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

    • Not Provided (No human subject test set is described where expert ground truth would be established.)

    4. Adjudication method for the test set

    • Not Provided (No human subject test set is described requiring adjudication.)

    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. This device is an infrared lamp for therapeutic heating, not an AI-assisted diagnostic or interpretive device that would involve human readers or MRMC studies.

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

    • Yes, in a sense. The testing described (functional performance and electrical safety) assesses the device's inherent operation without human interpretation. However, it's not an "algorithm-only" performance in the context of AI, but rather the performance of the physical medical device.

    7. The type of ground truth used

    • Functional Performance: Implicitly, "a level of tissue temperature reported in the literature and accepted by the Federal Food and Drug Administration." This refers to established physiological effects of heat therapy.
    • Electrical Safety: Compliance with national/international electrical safety standards.
    • Intended Use & Characteristics: Comparison to legally marketed predicate devices.

    8. The sample size for the training set

    • Not Applicable/Not Provided. This device is a physical therapeutic device, not an AI model that requires a training set in the conventional sense.

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

    • Not Applicable/Not Provided.
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