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510(k) Data Aggregation

    K Number
    K073273
    Device Name
    EQUAL DOSE 1.0
    Date Cleared
    2007-12-11

    (20 days)

    Product Code
    Regulation Number
    892.5050
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    EQUAL DOSE 1.0

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

    EQUAL Dose 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

    Device Description

    MUV 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

    The software requires beam data for individual treatment plans to be imported through the DICOM RT Plan format. The parameters associated with the treatment delivery on the accelerator can not be edited within the software, although parameters reliated to the calculation inside the patient/phantom, such as the coordinates and depths of the calculation points, are open for editing.

    The software is validated for broad megavoltage photon beams in the range from 4 up to 30 MV, delivered by standard medical linear accelerators (linacs),

    The software runs on a Windows XP platform.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "Nucletron EQUAL Dose 1.0" device, a Radiation Therapy Verification Tool. However, the document does not contain specific information regarding acceptance criteria, a detailed study proving device performance against those criteria, or the methodology used for establishing ground truth or expert involvement.

    The document primarily focuses on:

    • Substantial equivalence to a predicate device (MDS Nordion DCM1.0).
    • Description and intended use of EQUAL Dose 1.0 as a Quality Assurance (QA) tool for verifying dose calculations in external beam therapy.
    • Administrative details of the 510(k) submission and FDA's clearance letter.

    Therefore, I cannot provide the requested table or detailed study information based on the given text. The text explicitly states that EQUAL Dose 1.0 is "merely a verification tool" and validates it for "broad megavoltage photon beams in the range from 4 up to 30 MV". This implies that its "performance" would likely be assessed by how accurately its dose calculations compare to accepted physics models and/or measurements, but the document does not provide the acceptance criteria for these comparisons or the study results.

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