BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERJET CARIES ASSIST

    MDR report key: 21395648 · Received February 18, 2025

    Report

    Report Number
    MW5166306
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Report Date
    February 10, 2025
    Manufacturer
    OVERJET
    Product Code
    MYN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE 510(K) SUBSTANTIAL EQUIVALENCE REPORT FOR OVERJET CARIES ASSIST (K212519) SHOWS SENSITIVITY AND SPECIFICITY OF 72.0% AND 98.1%, RESPECTIVELY, FOR CARIES DETECTION. HOWEVER, CALCULATIONS BASED ON THE TABLE IN SECTION 10 REVEAL A POSITIVE PREDICTIVE VALUE OF ONLY 57.2%. THIS MEANS THAT 42.8% OF OBSERVED CARIES BY THE OVERJET PRODUCT WERE NOT ACTUALLY CARIES ACCORDING TO GROUND TRUTH. SUCH A HIGH RATE OF FALSE POSITIVES HAS THE POTENTIAL TO RESULT IN OVER-TREATMENT DUE TO FALSELY IDENTIFYING A CARIOUS LESION WHEN NONE EXISTS. THE POSITIVE AND NEGATIVE PREDICTIVE VALUES WERE NOT REPORTED IN THE PERFORMANCE TESTING AND DO NOT APPEAR TO HAVE BEEN CONSIDERED BY THE 510(K) PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41695 OVERJET CARIES ASSIST ANALYZER, MEDICAL IMAGE MYN OVERJET

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown