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510(k) Data Aggregation

    K Number
    K103093
    Device Name
    LEKSELL GAMMAPLAN
    Manufacturer
    ELEKTA INSTRUMENT AB
    Date Cleared
    2010-12-21

    (63 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K090972,K092132
    Predicate For
    K151666
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®.

    Device Description

    Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife®. Leksell Gamma Plan® is intended to be used for planning the dosimetry of treatments, in stereotactic radiosurgery and stereotactic radiotherapy.

    AI/ML Overview

    The provided text describes the Leksell GammaPlan®, a computer-based dose planning system for Leksell Gamma Knife®, and its 510(k) submission. However, it does not contain information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established for training or test sets.

    The document is a 510(k) summary for the device, focusing on its substantial equivalence to predicate devices (Leksell GammaPlan® K090972 and XiO RTP K092132) rather than detailed performance study results. The FDA letter confirms the substantial equivalence determination but does not present a detailed study.

    Therefore, I cannot provide the requested information.

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