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    K Number
    K024101
    Device Name
    PHOENIX UNIVERSAL SHUNT SYSTEM
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    2003-01-27

    (46 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PHOENIX UNIVERSAL SHUNT SYSTEM

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

    The Universal Shunt System is intended for use as the principle pressure-regulating component of a cerebrospinal fluid shunt assembly, used in the treatment of hydrocephalus.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt. The document is a clearance letter from the FDA for a device called "Phoenix Universal Shunt System" and primarily discusses regulatory matters, product classification, and general marketing stipulations.

    It does not include any details about:

    1. Acceptance criteria or reported device performance
    2. Sample sizes for test sets or their data provenance
    3. Number or qualifications of experts for ground truth
    4. Adjudication methods
    5. Multi-reader, multi-case (MRMC) comparative effectiveness studies
    6. Standalone algorithm performance studies
    7. Type of ground truth used
    8. Sample size for training sets
    9. How ground truth for training sets was established

    Therefore, I cannot provide the requested table or answer the specific questions based on the input text.

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