{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3","statisticalMethod":"t-test, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.8","upperLimit":"3.3","value":"3.1"},{"groupId":"OG001","lowerLimit":"2.6","upperLimit":"3.2","value":"2.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"57"}],"units":"Participants"}],"description":"Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; 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 total thyroidectomy procedure.\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, as per device functionality requirements.","id":"OG000","title":"PTeye"},{"description":"The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying 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":"Immediate (During total thyroidectomy procedure)","title":"The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient","type":"PRIMARY","unitOfMeasure":"parathyroid glands per patient"}