(364 days)
The Oxehealth Vital Signs device is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.
The Oxehealth system is intended for use by appropriately trained staff with a duty of care, and should not be used by untrained users.
The Oxehealth Vital Signs device is indicated for use on humans 18 years of age or older who do not require critical care or continuous vital signs monitoring.
The device is not intended to be the sole method of checking the physical health of a subject.
The device is a software algorithm that reads data collected using off-the-shelf cameras collecting images in the near-infrared spectrum. These images can be used to act as a non-contact monitor of pulse and breathing rates for individuals aged 18 and older in single-subject room environments. Pulse rate is determined by monitoring pixel intensity changes for exposed skin. Breathing rate is determined with motion tracking of the patient's chest. Video is collected through video cameras installed in each room. When run through proprietary software-controlled algorithms, the software will allow a user to make spot checks for pulse and estimated breathing rates (chest wall movements) of the individual in the room. This allows vital monitoring without disturbing the patient either to allow for patient rest or to protect staff that would otherwise need to enter the room with a potentially dangerous patient.
Off-the-shelf components must meet specifications set by the sponsor in order to ensure they will provide adequate quality video capture for analysis by the medical device.
Here's a breakdown of the Oxehealth Vital Signs device's acceptance criteria and the study proving it, based on the provided text:
Oxehealth Vital Signs Device Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Vital Sign | Acceptance Criteria (Study Objective) | Reported Device Performance (RMSD) | One-sided 97.5% Confidence Interval |
|---|---|---|---|
| Pulse Rate |
§ 870.2785 Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
(a)
Identification. The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, breathing rate, and/or respiratory rate. This device is not intended to independently direct therapy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must include:
(i) A full characterization of the software technical parameters, including algorithms;
(ii) If required image acquisition hardware is not included with the device, full specifications of the hardware requirements and testing to demonstrate the specified hardware ensures adequate data for validated and accurate measurements;
(iii) A description of the expected impact of all applicable sensor acquisition hardware characteristics and associated hardware specifications;
(iv) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy; and
(v) Software documentation must include a cybersecurity vulnerability and management process to assure software functionality.
(2) Clinical data must be provided. This assessment must fulfill the following:
(i) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified.
(ii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment.
(iii) The assessment must compare device output with a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner.
(3) A human factors and usability engineering assessment must be provided that evaluates the risk of improper measurement.
(4) Labeling must include:
(i) A description of what the device measures and outputs to the user;
(ii) Warnings identifying sensor acquisition factors or subject conditions or characteristics (garment types/textures, motion, etc.) that may impact measurement results;
(iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information;
(iv) The expected performance of the device for all intended use populations and environments; and
(v) Robust instructions to ensure correct system setup.