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510(k) Data Aggregation

    K Number
    K962916
    Device Name
    HUA-XIA ACUPUNCTURE NEEDLES
    Manufacturer
    LHASA MEDICAL, INC.
    Date Cleared
    1996-08-23

    (28 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HUA-XIA ACUPUNCTURE NEEDLES

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    This document is a Summary Statement of Safety and Effectiveness for a medical device (acupuncture needles) seeking 510k clearance from the FDA. It is not a study report that describes acceptance criteria and device performance based on a study.

    Therefore, I cannot provide the requested information because the provided text does not contain:

    1. A table of acceptance criteria and reported device performance: The document states the device "meets the general specifications and parameters for an acupuncture needle," but it doesn't define what those specifications or parameters are, nor does it provide a table with quantitative performance metrics.
    2. Sample size used for the test set and data provenance: There is no mention of a specific test set, its size, or the origin of any data (e.g., country, retrospective/prospective).
    3. Number of experts and their qualifications for ground truth: No experts or ground truth establishment methods are discussed.
    4. Adjudication method: Not applicable as no ground truth establishment is described.
    5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned or implied.
    6. Standalone (algorithm only) performance: This is a physical medical device, not an algorithm.
    7. Type of ground truth used: Not applicable as no specific study data or ground truth is presented.
    8. Sample size for the training set: Not applicable as this is not a machine learning study.
    9. How ground truth for the training set was established: Not applicable.

    The document primarily makes a declarative statement that the Hua-Xia acupuncture needle "meets the criteria for 510k acceptance" and is "equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976" and to "other acupuncture needles which are now being sold through interstate commerce." This equivalence claim is based on the general understanding and history of acupuncture needle use, and its sterile, single-use nature, rather than a specific performance study detailed within this summary.

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