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510(k) Data Aggregation

    K Number
    K051046
    Device Name
    PAINACEA MODEL XR8 INFRARED HEAT LAMP
    Manufacturer
    ATLANTIS LUMINESCENT PRODUCTS, LLC
    Date Cleared
    2005-05-10

    (15 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K024027,K032229
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Painacea Model XR8 infrared heat lamp is intended to emit energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.

    Device Description

    The Painacea Model XR8 consists of a collection of near and infrared diodes [LEDs], packaged in a compact handheld device. The system emits light in the infrared spectrum to provide topical heating. The red diodes [LEDs], provide a visible indication that the unit is in operation. The battery and operating system is contained within the handheld device. The device has a cradle with wall power supply to recharge the battery.

    AI/ML Overview

    The provided text is a 510(k) summary for the Painacea Model XR8 Infrared Heat Lamp. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information (acceptance criteria, study design details like sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types for test/training sets, and training set sample size) is not present in this document.

    The document mainly covers the device's description, intended use, and comparison to predicate devices. It states that the device was deemed "substantially equivalent" to existing infrared lamps on the market based on functional performance and electrical safety testing, not a clinical effectiveness study with defined acceptance criteria for clinical outcomes.

    Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Explicitly Stated in Document)Reported Device Performance
    No explicit clinical acceptance criteria (e.g., pain reduction percentage, temperature delta) are stated in the document."The system performs as intended and does not raise any new safety or effectiveness issues."
    Functional performance adherenceFunctional performance testing was conducted. (No specific metrics or results detailed.)
    Electrical safety adherenceElectrical safety testing was conducted. (No specific metrics or results detailed.)
    Equivalence to predicate devices in intended use"The Painacea Model XR8 has the same intended uses... as the predicate devices."
    Equivalence to predicate devices in technological characteristics"similar technological characteristics as the predicate devices." (e.g., "temperatures achieved by these devices are the same, using a similar number of diodes [LEDs], over a similar coverage area.")
    OTC device labeling compliance"The labeling, instructions, and User Operations... are designed for layman understanding and use."

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Sample Size: Not applicable/Not provided. This document describes testing for functional performance and electrical safety, not a clinical study with a "test set" of patients or data in the typical sense.
    • Data Provenance: Not applicable/Not provided.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not applicable/Not provided. "Ground truth" in the context of clinical studies is not relevant to the functional and electrical safety testing mentioned.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not applicable/Not provided.

    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

    • Not applicable/Not provided. This is an infrared heat lamp, not an AI diagnostic device that would involve human readers or AI assistance.

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

    • Not applicable/Not provided. This is a physical device, not an algorithm. Its "standalone" performance would refer to its functional and electrical safety, which were tested.

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

    • Not applicable/Not provided. The "ground truth" for the functional and electrical safety testing would be objective measurements and adherence to engineering standards, not clinical outcomes data or expert consensus on a disease.

    8. The sample size for the training set

    • Not applicable/Not provided. The device testing described does not involve machine learning or a "training set."

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

    • Not applicable/Not provided.
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