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510(k) Data Aggregation

    K Number
    K070442
    Manufacturer
    Date Cleared
    2007-03-16

    (29 days)

    Product Code
    Regulation Number
    878.4580
    Reference & Predicate Devices
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAQUET S.A.

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

    MAQUET POWERLED™ Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the patient.

    An "LED inside" feature is available which produces lower intensity levels of ambient light, intended for minimally invasive surgery, procedures and examination.

    An added optional patented automatic head recognition system feature is available to reduce the heat projected on to the surgeon's: head, and to compensate for loss of illumination due to an obstacle in front of the supola.

    Device Description

    The POWERLED™ Surgical Light System is a new product designation intended to identify a family of surgical lights that will use a similar set of design principles as the ALM X'TEN® (X10) Surgical Light Systems.

    The POWERLED™ Surgical Light provides a broadened set of features and options that include LEDs as the main light source as well as an added optional automatic head recognition system feature as a result of this redesign effort.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner expected for an AI/ML device. The document is a 510(k) summary for a surgical light system, which is a physical device, and therefore the concepts of "test set," "training set," "ground truth," "experts," and "MRMC study" do not apply in the context of AI/ML evaluation.

    The "Test Data" section refers to conformance with various electrical, safety, and electromagnetic compatibility standards, along with software testing according to FDA guidance. These are typical regulatory requirements for medical devices, but they do not involve the statistical performance evaluation metrics associated with AI/ML systems.

    Therefore, I cannot extract the requested information from the provided text.

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