{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":".6","statisticalMethod":"t-test, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.4","upperLimit":"2.9","value":"2.7"},{"groupId":"OG001","lowerLimit":"2.3","upperLimit":"2.8","value":"2.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"79"}],"units":"Participants"}],"description":"Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye.","dispersionType":"95% Confidence Interval","groups":[{"description":"The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery.\n\nPTeye: The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console (see Figure 1), as per device functionality requirements.","id":"OG000","title":"PTeye"},{"description":"The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.","id":"OG001","title":"Standard of Care"}],"paramType":"MEAN","reportingStatus":"POSTED","timeFrame":"Measured within the procedure, generally not more than 2 hours","title":"Average Number of Parathyroid Glands Identified","type":"PRIMARY","unitOfMeasure":"parathyroid glands per patient"}