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FDA reviewers report a sensitivity of 80.4% (37/46) and a specificity of 66.1% (156/236). Neither reached the goal of a lower confidence limit above 70%. The negative predictive value was 94.5%, and the positive predictive value was 31.6%. FDA granted the De Novo request on 28 December 2018 and judged that the probable benefits outweigh the probable risks. It authorized the device only as an aid to a standard neurological assessment. 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Software applies a model to the gaze data and gives a score from 0 to 20, and a score of 10 or more is positive. In the clinical study that FDA reviewed, 282 patients with head injury were analyzed. A clinical reference standard defined concussion. Investigators revised it during the study because clinicians were often uncertain. FDA reviewers report a sensitivity of 80.4% (37/46) and a specificity of 66.1% (156/236). Neither reached the goal of a lower confidence limit above 70%. The negative predictive value was 94.5%, and the positive predictive value was 31.6%. FDA granted the De Novo request on 28 December 2018 and judged that the probable benefits outweigh the probable risks. It authorized the device only as an aid to a standard neurological assessment. The study measured accuracy and did not measure patient outcomes.","replication":{"produced_by":["The patient watched a video move around a screen five times while a camera tracked both eyes at 500 frames per second.","A reference standard based on concussion symptom and cognitive scores defined each case."],"must_hold":["The patient is 5 to 67 years old and within one week of a head injury.","Clinicians use the result with a standard neurological assessment and do not rely on it alone.","The patient has no disorder of eye movement and is not intoxicated."],"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":"04c098bbe37c8c17f66803b21d0bdd4b6c8f0677b51da1e698114b80240ecc2a"}