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510(k) Data Aggregation

    K Number
    K232031
    Device Name
    LUNA 3D
    Manufacturer
    LAP GmbH Laser Applikationen
    Date Cleared
    2024-03-29

    (266 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K212583
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LAP LUNA 3D system is used to support reproducible patient positioning and monitor patient surface motion during radiotherapy and radiosurgery treatments and during CT simulation for radiation therapy planning. LAP LUNA 3D may also be used to guide patients through breath-holds. The LAP LUNA 3D system can be used for all patients, undergoing radiotherapy and radiosurgery treatments and radiosurgery treatments and CT simulation for radiation therapy planning.

    Device Description

    The LUNA 3D optical camera system captures the current 3D patient skin surface with one or multiple camera pods. The software calculates the spacial deviations between the captured live surface and a reference surface within a selected region of interest using a registration algorithm. Reference surfaces may be generated with the optical camera system or may be imported using data received from Treatment Planning Systems (TPS). Based on the registration results the user can adjust the patient position for reproducible patient positioning relative to the treatment isocenter. During the imaging (simulation) and treatment delivery process, the system continuously calculates the deviations between live- and reference surface for patient motion monitoring to ensure that the patient position remains within pre-defined tolerances.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study information for the LUNA 3D device based on the provided FDA 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    The FDA 510(k) summary provides limited detailed acceptance criteria and mostly focuses on comparison to a predicate device. The performance claims primarily relate to accuracy.

    Acceptance Criteria / Performance MetricReported Device Performance (LUNA 3D)
    Positioning AccuracyTarget registration errors (as measured using calibration phantom)
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