(270 days)
The FH Vitals SDK is designed to measure the pulse rate based on the given facial video stream. It is intended for non-invasive spot measurements of pulse rate when the subject is still. This SDK is not intended for use in patients with known or suspected heart arrhythmias.
While the SDK can be used for general healthcare, it is not designed to treat patients. The pulse rate measurement results provided by the FH Vitals SDK should complement, but not replace, the user's usual professional medical care and/or medication. If abnormalities are detected during the measurement with the FH Vitals SDK, users are advised to consult a medical professional.
The FH Vitals SDK is indicated for use in humans 18 years of age or older who do not require critical care or continuous vital signs monitoring. This software should not be the primary or sole method for assessing an individual's health.
FH vitals SDK is a video-based, non-contact pulse rate measurement software with a face recognition function designed to measure and real-time display the pulse rate of adults. This system uses cameras to detect the user's face and obtains the continuous face image data, with signal processing and algorithm to compute the pulse rate. The software is intended to be installed on commercial mobile devices/laptops/computers equipped with cameras. It can be deployed on Android, iOS platform and Windows platforms.
Here's a breakdown of the acceptance criteria and the study details for the FaceHeart Vitals Software Development Kit (FH vitals SDK):
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance) | Reported Device Performance (FH vitals SDK) |
|---|---|
| Pulse Rate Measurement Range | 50-180 bpm |
| Performance (Error Level) | ±3 bpm |
The document notes that the predicate device had a pulse rate measurement range of 50-130 bpm and the same performance error level of ±3 bpm. The FH vitals SDK can measure a wider range of pulse rates.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 527 participants.
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "clinical study," which implies it was prospective data collection.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not specify the number of experts used or their qualifications for establishing the ground truth.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method. It implies a direct comparison to the reference device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The study compares the stand-alone performance of the FH Vitals SDK to a reference device.
6. Stand-Alone Performance (Algorithm Only without Human-in-the-Loop Performance):
Yes, a standalone performance study was done. The clinical study compares the FH Vitals SDK's pulse rate measurements against a reference device (Philips MX100 ECG) without human assistance being part of the measurement process.
7. Type of Ground Truth Used:
The ground truth used was established by a clinically accurate patient-contacting relevant comparator device, specifically the Philips MX100 ECG.
8. Sample Size for the Training Set:
The document does not provide information on the sample size used for the training set. It mentions "Software documentation included a description of algorithm training and validation data," but does not give specific numbers for the training set itself.
9. How the Ground Truth for the Training Set Was Established:
The document does not explicitly state how the ground truth for the training set was established. It generally refers to "algorithm training and validation data" but doesn't detail the method for labeling or establishing truth for that data.
§ 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.