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510(k) Data Aggregation

    K Number
    K073020
    Device Name
    ECLIPSE TREATMENT PLANNING SYSTEM
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Date Cleared
    2007-12-19

    (54 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Type
    Special
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K010975,K070978,K021268,K041403,K071783,K071873
    Why did this record match?
    Reference Devices :

    K010975, K070978, K021268, K041403, K071783

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

    The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

    Device Description

    The Varian Eclipse™ Treatment Planning System (Eclipse TPS) (K071873) provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse TPS is a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments. Eclipse TPS is capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation, (brachytherapy) treatments.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification for the Varian Medical Systems, Inc. Eclipse Treatment Planning System (Eclipse TPS). It describes the device, its indications for use, and a comparison to a predicate device. However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

    The document is primarily focused on demonstrating substantial equivalence to a previously cleared device (Eclipse K071873) by comparing their indications for use, algorithm features, and other features.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for test sets or data provenance.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results.
    6. Standalone algorithm performance studies.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This type of detailed study information is typically found in engineering reports or validation studies submitted as part of the 510(k) application, but it is not commonly included in the publicly available 510(k) summary document itself. The summary focuses on high-level comparisons for substantial equivalence.

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