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510(k) Data Aggregation

    K Number
    K965010
    Manufacturer
    Date Cleared
    1997-07-23

    (219 days)

    Product Code
    Regulation Number
    892.5050
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Target 2 V1.1 is a radiation oncology treatment planning system which uses CT and non-CT data to produce External Beam and Irregular Field plans, and non-CT data to provide Interstitial/Intracavitary Dosimetry plans.

    Device Description

    The Target 2 V1.1 is an independent radiation oncology treatment planning system which uses CT and non-CT data to produce External Beam and Irregular Field plans, and non-CT data to provide Interstitial/Intracavitary Dosimetry plans. The system is interactive, using an optical mouse and defined display screen areas on the monitor, in conjunction with operating menus, to produce accurate planning routines. The treatment plan is contructed and displayed on the patient image. Plans can be stored on the system disk, output as hard copy and archived.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a Radiation Treatment Planning (RTP) system, specifically the "Target 2 Version 1.1". It primarily focuses on demonstrating substantial equivalence to a predicate device (Target 2 Version 1.0) rather than presenting a detailed study with acceptance criteria, sample sizes, and expert adjudication for a novel AI-powered device.

    Therefore, the document does not contain the information required to answer your request about acceptance criteria, a study proving the device meets them, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI device.

    The document makes a high-level statement: "Test results indicate that Target 2 V1.1 performs its intended use and meets specifications in a safe and effective manner." However, it does not provide any specifics about these "test results" or "specifications" beyond stating its intended use is for planning radiation oncology treatments.

    In summary, the information requested is not present in the provided text. This is a regulatory submission for a software update to a radiation treatment planning system, not a clinical validation study for an AI algorithm.

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