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510(k) Data Aggregation

    K Number
    K020934
    Manufacturer
    Date Cleared
    2002-10-25

    (217 days)

    Product Code
    Regulation Number
    868.5150
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For spinal administration of anesthetic agents to provide regional anesthesia.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text ({0}, {1}, {2}, {3}) does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification response from the FDA regarding a spinal needle, confirming its substantial equivalence to a legally marketed predicate device. It briefly mentions the "Indication For Use" of the device, but there are no details about specific performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

    Therefore, I cannot provide the requested table or answer the specific questions about a device study.

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