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510(k) Data Aggregation

    K Number
    K012575
    Device Name
    PREFERNCE IMRT TREATMENT PLANNING MODULE
    Manufacturer
    NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
    Date Cleared
    2002-03-12

    (215 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K970464,K983793
    Why did this record match?
    Reference Devices :

    K970464, K983793

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

    The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.

    The expanded indications for use are also applicable as previously presented for pReference Treatment System (K983793), including hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.

    The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a 510(k) premarket notification letter from the FDA regarding the "pReference IMRT Treatment Planning Module" and its indications for use. It primarily focuses on the regulatory approval and substantial equivalence to predicate devices.

    The document does NOT contain information about specific acceptance criteria, a study proving the device meets those criteria, or the detailed methodology of such a study.

    Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported performance, nor can I answer questions about:

    • Sample sizes (test, training) or data provenance
    • Number of experts or their qualifications
    • Adjudication methods
    • MRMC comparative effectiveness study or effect size
    • Standalone performance
    • Type of ground truth used
    • How ground truth for training was established

    The letter only states that the device is "substantially equivalent" to legally marketed predicate devices for its stated indications for use. This means the FDA determined it performs as safely and effectively as existing, legally marketed devices, but it does not detail the specific performance metrics or studies that would typically be associated with defined acceptance criteria.

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