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510(k) Data Aggregation

    K Number
    K142439
    Device Name
    Martinez Prostate Template Set
    Manufacturer
    Nucletron BV
    Date Cleared
    2015-03-10

    (193 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Martinez Prostate Template Set

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

    The Martinez Prostate Template Set is for assisting interstitial HDR/PDR brachytherapy of the prostate gland, to be used only by trained physicians. The maximum application duration per treatment application is 28 days.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study that proves the device meets acceptance criteria for the "Martinez Prostate Template Set." The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device. It specifies the indications for use but does not detail performance metrics, study design, or results.

    Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

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