OVERJET CARIES ASSIST

Description of Event or Problem

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.