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510(k) Data Aggregation

    K Number
    K200636
    Device Name
    AXUS ES-5 Electro-Acupuncture Device
    Manufacturer
    Lhasa OMS, INC.
    Date Cleared
    2021-02-03

    (330 days)

    Product Code
    BWK
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K081943
    Why did this record match?
    Device Name :

    AXUS ES-5 Electro-Acupuncture Device

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

    The AXUS ES-5 Electro Acupuncture Device is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the states.

    Device Description

    The AXUS ES-5 is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the state. The AXUS ES-5 is a battery operated prescription use only electro-acupuncture device used for applying electric stimuli to areas of preferred delivery (APD). The device uses a low-intensity, low-frequency pulse multimode generator through microalligator clips attached to commercially available and FDA-cleared stainless steel acupuncture needles. The device can also deliver stimulation with the included probe.

    AI/ML Overview

    The provided text is a 510(k) summary for the AXUS ES-5 Electro-Acupuncture Device. It describes the device, its intended use, and its similarities to a predicate device (ES-130). However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of AI/ML performance evaluation.

    The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, primarily through:

    • Technological characteristics: Comparing waveform shapes, maximum frequency, output voltage/current, power density.
    • Performance testing: Stating that the device conforms to applicable technical standards, including electrical safety, electromagnetic compatibility, and biocompatibility.

    There is no mention of a study involving AI, machine learning, human readers, or any metrics like sensitivity, specificity, or AUC related to diagnostic performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets the acceptance criteria, as the provided text does not contain such information for this medical device clearance. The device is a physical electro-acupuncture device, not an AI/ML-driven diagnostic tool.

    If you have a document describing the testing for an AI/ML medical device, I would be happy to analyze it according to your criteria.

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