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510(k) Data Aggregation

    K Number
    K170355
    Device Name
    RayStation 6
    Manufacturer
    RaySearch Laboratories AB (publ)
    Date Cleared
    2017-03-02

    (24 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K160093
    Why did this record match?
    Device Name :

    RayStation 6

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

    RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.

    The system functionality can be configured based on user needs.

    The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

    Device Description

    RayStation 6.0 is a radiation therapy treatment planning system, i.e. a software program for planning and analysis of radiation therapy treatment plans. Functionality includes fusion capabilities (CT, PET and MRI), contouring, collapsed cone convolution dose computation and 4D data compatibility, as well as unique features such as multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available on one platform.

    AI/ML Overview

    This document is describing a 510(k) premarket notification for a medical device (RayStation 6.0), which aims to show substantial equivalence to a predicate device (RayStation 5.0). The provided text describes the software's functionality and its intended use but does not contain details about a study with acceptance criteria and device performance data in the context of an AI/human reader comparative study or standalone algorithm evaluation.

    The sections "5.11 Assessment of non-clinical performance data" and "5.12 Test conclusion" briefly state that "The test specification of RayStation 6.0 is a further developed version of the test specification of RayStation 5.0" and that "The successful verification and validation of RayStation 6.0 therefore support the substantial equivalence of the above RayStation versions." However, it does not provide any specific acceptance criteria or performance metrics.

    Therefore, I cannot fulfill your request for the detailed table and study information based solely on the provided text. The document focuses on regulatory submission aspects (e.g., 510(k) summary, intended use, technological characteristics comparison to a predicate device) rather than clinical performance data with specific acceptance criteria.

    To answer your request, I would need a document that presents:

    • Specific quantitative acceptance criteria (e.g., sensitivity, specificity, AUC thresholds).
    • The actual reported performance of the device against these criteria.
    • Details about the study design (sample size, data provenance, ground truth establishment, reader studies if applicable).
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