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510(k) Data Aggregation

    K Number
    K160680
    Device Name
    VisioFocus Mini, VisioFocus Smart
    Manufacturer
    TECNIMED S.R.L.
    Date Cleared
    2017-04-19

    (405 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VisioFocus Mini, VisioFocus Smart

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

    VisioFocus SMART and VisioFocus Mini are infrared thermometers intermittent measurement of human body temperature in people of all ages. This thermometer is for a measurement site of forehead.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA for a clinical electronic thermometer (VisioFocus SMART and VisioFocus Mini). It primarily focuses on the device's substantial equivalence to a predicate device and its indications for use.

    Therefore, this document does not contain the information requested regarding the acceptance criteria and the study that proves the device meets those criteria. Specifically, it lacks:

    • A table of acceptance criteria and reported device performance.
    • Details on sample sizes and data provenance for test sets.
    • Information on ground truth establishment, including the number and qualifications of experts and the adjudication method.
    • Any mention of Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.
    • Information about the training set's size or ground truth establishment.

    The document is a regulatory approval letter, not a scientific study report.

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