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    K Number
    K051746
    Device Name
    ELEKTA ESARTE FRAME SYSTEM
    Manufacturer
    ELEKTA INSTRUMENT AB
    Date Cleared
    2005-07-25

    (26 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K031980,K031999,K972324
    Why did this record match?
    Device Name :

    ELEKTA ESARTE FRAME SYSTEM

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

    The Elekta Esarte™ Frame System is part of Leksell Stereotactic System®, which is intended for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.

    Device Description

    The Elekta Esarte™ Frame System is used in stereotactic radiation therapy (SRT) to provide target localization (spatial reference), and the fixation of the patient's head at prescribed geometric coordinates on the Precise table top of the digital accelerator. The Elekta Esarte™ Frame also attaches to the table of the CT scanner that is used to acquire images for the SRT planning.

    AI/ML Overview

    The provided document is a 510(k) summary for the "Elekta Esarte™ Frame System," a stereotactic instrument. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study evaluating the performance of an AI-powered device. Therefore, the information requested in the prompt about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth for an AI device is not available in the provided text.

    The document focuses on:

    • Device Description: The Elekta Esarte™ Frame System is used in stereotactic radiation therapy (SRT) for target localization and patient head fixation.
    • Intended Use: Localization and diagnosis of intracranial disorders and their surgical treatment, including radiosurgery and stereotactic radiation therapy, as part of the Leksell Stereotactic System®.
    • Substantial Equivalence: The device is claimed to be substantially equivalent in safety and effectiveness to its predicate device, the Leksell® Stereotactic System with disposable biobsy needle kit (K031980), with similar fundamental technical characteristics.
    • Regulatory Classification: Class II device, product code HAW (Stereotaxic instrument) and LHN (Medical charged-particle radiation therapy system).

    Since this document is a 510(k) summary for a physical medical device and not an AI or software as a medical device, it does not contain the information required to answer the prompt. There are no performance metrics, clinical study details, or AI-specific validation information to report.

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