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It estimates pulse from changes in the intensity of skin pixels and breathing rate from chest movement. Staff can take spot checks without entering the room or disturbing the patient. In an observational study that FDA reviewed, 60 adults aged 18 to 81 were measured with the software and with a standard contact device. FDA reviewers report a root mean square difference of 1.81 bpm for pulse and 1.17 breaths/minute for breathing, below objectives of three and two. Only 58% of attempts gave a pulse rate, and 73% gave a breathing rate. The reviewers note that patients checked by an installation outside the United States preferred contactless checks because these did not disturb their sleep. FDA granted the De Novo request on 26 March 2021. The study measured accuracy alone and did not measure risk to staff or patients.","replication":{"produced_by":["Fixed near-infrared cameras recorded each single-occupancy room.","The subject was still, with enough exposed skin and chest movement visible to the camera."],"must_hold":["Trained staff with a duty of care take the readings as spot checks alongside periodic checks in person.","The subject is an adult who does not need intensive care or continuous monitoring of vital signs."],"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":"a97205c2e6995ad84c9e9f9d5d33b2029d5606a8a6e3ea4743d1d6ae7077bd3e"}