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FDA reviewers report a sensitivity of 78.5% and a specificity of 48.6%. Both fell short of endpoints that required lower confidence limits above 78% and 50%. The negative predictive value was 89.5% at a prevalence of 21%. Using educated assumptions, FDA estimated that about 160 patients, 29%, might have been spared exposure to CT. FDA granted the De Novo request on 17 November 2014. 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Its algorithm combines EEG features into a classification that was set in a separate earlier study. In the B-AHEAD II study, 817 patients were enrolled at 11 emergency departments in the United States, and 552 were analyzed. Treating physicians did not see the device output, and three neuroradiologists read the CT scans. FDA reviewers report a sensitivity of 78.5% and a specificity of 48.6%. Both fell short of endpoints that required lower confidence limits above 78% and 50%. The negative predictive value was 89.5% at a prevalence of 21%. Using educated assumptions, FDA estimated that about 160 patients, 29%, might have been spared exposure to CT. FDA granted the De Novo request on 17 November 2014. The reviewers note concerns about missing data and about how the need for CT was judged.","replication":{"produced_by":["Staff recorded EEG from frontal electrodes in the emergency department within 24 hours of the injury.","The classification algorithm was fixed before the validation study."],"must_hold":["The patient is 18 to 80 years old with a closed head injury and a Glasgow Coma Scale score of 13 to 15.","Clinicians use the result with standard assessment and never as a substitute for a CT scan."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":27,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":25,"review_not_assessed":64,"not_assessed":0,"complete":false,"by_state":{"value_present":27,"not_reported":0,"unresolved":64,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"b2be4fcd18cce38b593a6cdfe0930edc85cd9e5edef8a0d2bf5826c3f1cf27d8"}