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510(k) Data Aggregation

    K Number
    K021987
    Device Name
    PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY
    Manufacturer
    S&S PAR SCIENTIFIC
    Date Cleared
    2002-12-27

    (192 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY

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

    To shape the beam for a radiation therapy source.

    Device Description

    ParComPlast™ is a solid block of polyurethane and fillers. It is intended to be used as material for construction of beam intensity modifiers for radiation therapy treatment. In use, a block of ParComPlast™ is placed into the holder of a milling machine such as described in our 510(k) K#883317, or, in similar machines produced by other manufacturers: a beam modifying filter is milled out using the x, y, z data supplied by either the planning computer or our contouring system. Once the filter is machined, it is mounted to the shadow tray plate using screws or double face tape and the plate is inserted into the holder on the accelerator for the patient's treatment.

    AI/ML Overview

    The provided document is a 510(k) summary for the ParComPlast™ Compensating Filter for Radiation Therapy. This device is a material used for constructing beam intensity modifiers in radiation therapy.

    This document describes non-clinical testing for material substantial equivalence, not a study of device performance against acceptance criteria in the typical sense of diagnostic or AI-driven medical devices.

    Therefore, most of the requested information (such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this type of submission. This device is a component material, and its evaluation focuses on material properties rather than diagnostic accuracy or clinical outcomes.

    However, I can extract the relevant information from the document as it pertains to the material's equivalence.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Material performance for use as a compensator in radiation therapy, comparable to aluminum."ParComPlast™ can be used as compensator material on a similar level as aluminum (is used clinically)."
    No difference in material behavior compared to materials used in predicate devices."There is no difference in material behavior as materials used in the predicate devices."
    No new questions of safety or effectiveness raised by technological characteristics.Non-clinical testing demonstrates "no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness."

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for Test Set: Not specified in terms of clinical cases or patient data, as this was a non-clinical material test.
    • Data Provenance: Not applicable for this type of material evaluation. The testing was non-clinical.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    • Number of Experts: Not applicable. Ground truth was established through non-clinical material testing, not expert consensus on patient data.
    • Qualifications of Experts: Not applicable.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not applicable, as this was a non-clinical material test, not an evaluation requiring human adjudication of clinical data.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

    • MRMC Study: No, an MRMC study was not done. This device is a material for radiation therapy equipment, not a diagnostic or AI-powered system where human reader performance would be a factor.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

    • Standalone Performance Study: No, a standalone performance study was not done. This device is a physical material, not an algorithm.

    7. The Type of Ground Truth Used

    • Type of Ground Truth: The ground truth was based on the performance and behavior of existing, clinically used materials (e.g., aluminum) for compensators in radiation therapy. This was established through non-clinical product testing to demonstrate material equivalence.

    8. The Sample Size for the Training Set

    • Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    • Ground Truth for Training Set: Not applicable, as this device does not use a training set.
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