PanopticAI Vital Signs

PanopticAI Vital Signs is a software medical device that measures pulse rate non-invasively using remote photoplethysmography (rPPG). It captures video of a person's face using an iPhone or iPad camera, analyzes subtle color changes in the skin to detect blood flow, and sends the data to a cloud server for processing. The result is displayed on the app. It is intended for use by healthcare professionals on healthy adults aged 18–60 who do not require critical care, and measurements should complement, not replace, professional medical care.

The subject device uses iPhone/iPad cameras with iOS/iPadOS 16.0 or above, while the predicate uses fixed-installation cameras and infrared illuminators. The subject device measures pulse rate only (50–130 ±3 bpm, 30-second window); the predicate also measures breathing rate. Both use rPPG algorithms and cloud-based processing. The subject device is intended for home and general clinic use; the predicate is for hospitals and secured environments. Clinical performance shows RMSE substantially equivalent between devices (subject: 0.99–1.16 bpm bias; predicate: 1.81 bpm RMSD).

ANSI AAMI IEC 62366-1:2015+AMD1:2020 (usability engineering); FDA Guidance for Device Software Functions (software verification and validation); FDA Guidance for Cybersecurity in Medical Devices (network security); Bland-Altman and regression analysis (clinical validation).

Both devices use the same fundamental rPPG technology to measure pulse rate from video with equivalent accuracy (RMSE/bias <2 bpm). Although the subject device is mobile (iPhone/iPad) versus fixed-installation and lacks breathing rate measurement, these differences do not raise new safety or effectiveness questions because: (1) clinical validation on 107 subjects with diverse demographics demonstrated equivalent performance across gender, age, race, BMI, and skin tone; (2) bench testing confirmed robustness to glasses, makeup, facial hair, distance, and lighting variation; (3) software and usability validation were conducted per FDA guidance; and (4) cybersecurity controls are documented. The narrower intended use (pulse rate only, healthy subjects, non-critical care) is less demanding than the predicate, and the platform difference is bridged by comprehensive validation on the actual hardware used.