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510(k) Data Aggregation
(107 days)
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
FH Vitals SDK-RR is a software-only respiratory rate measurement tool intended to be integrated into third-party software applications on compatible mobile devices, laptops, or computers. It is intended for spot checking of Respiration Rate (RR) in an automatic contactless manner by analyzing chest wall movement from video input when the subject is still and properly positioned in front of the camera in a well-lit environment.
FH Vitals SDK-RR is intended for use under the supervision of a healthcare professional, either in clinical or home environments, and is not intended for continuous monitoring, apnea detection, or as the sole method for evaluating physical health. It is intended to serve as a supplemental tool to assist in the overall assessment of the patient. The software is indicated for use on individuals aged 18 years and older who do not require critical care or continuous vital sign monitoring.
The FaceHeart Vitals Software Development Kit (FH Vitals SDK-RR) is a software product designed for integration into various software applications, such as those on mobile devices, laptops, or computers. This SDK is strictly a software-only product and is compatible with the following operating systems: Windows 10, Android 14, and iOS 17. It has been tested and is currently only compatible with the following cameras:
- Logitech C930 webcam
- Samsung S24+, S24+ smartphone front-facing cameras
- iPhone 15 Pro, and iPhone 15 Pro Max front-facing cameras
The SDK is non-contact and designed to measure the respiratory rate in breaths per minute based on facial video streams. When the SDK receives a video stream, it first identifies and tracks the face within the video, ensuring consistent positioning of the face. Based on the tracked facial region, the system identifies the chest as the region of interest (RoI) and locates reliable key points. The system then focuses on the movement of the chest within the RoI to further determine the number of respiratory cycles. By analyzing the frequency of chest elevation and depression, the SDK calculates the respiratory rate in breaths per minute.
FH Vitals SDK-RR is designed for non-invasive respiratory rate measurement with a validated measurement range of 5-36 bpm. The SDK is not intended for apnea monitoring or detecting the cessation of breathing. FH Vitals SDK-RR is a prescription-use software device that must be used under the clinical supervision or instruction of a licensed healthcare professional (HCP).
Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) Clearance Letter and 510(k) Summary.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Respiratory Rate Measurement Range | 5-36 bpm (Predicate: 7-30 bpm; Subject device: 5-36 bpm, validated through clinical testing, aligning with intended use population) |
| Performance (Error Level) | ±2 bpm (Predicate: ±3 bpm; Subject device: Root Mean Square Error (RMSE) for all tested devices was 1.2 bpm (95% CI), demonstrating deviations consistently within ±2 bpm when compared to the gold standard. p-values for RMSE > 2 bpm were below 0.001, indicating statistical significance.) |
| Measurement Window | 60 seconds (Same as predicate) |
| Performance Across Respiratory Rate Levels | RMSE ≤2 bpm across all RR ranges (5-8 bpm: RMSE 1.7-1.8 bpm; 9-11 bpm: RMSE 1.0-1.1 bpm; 12-19 bpm: RMSE 1.0-1.3 bpm; 20-29 bpm: RMSE 0.9-1.0 bpm; 30+ bpm: RMSE 1.1-1.2 bpm for all devices. All p-values 2 bpm) |
| Statistical Significance | p-values for RMSE > 2 bpm were below 0.001, confirming the results were statistically significant. |
| Consistency Across Devices | Coefficient of determination (R²) values exceeded 0.98 across all devices, indicating close alignment with the clinical reference device. |
| Performance Across Demographics | No significant differences in accuracy were found based on sex, age, or BMI, confirming consistent performance across demographic groups. |
| Performance Across Disease Subgroups | No major performance issues were noted in cardiovascular, neurological, or pulmonary patients, with minor underestimation in some conditions (e.g., Alzheimer's) still within acceptable limits. |
| Clothing Impact on Accuracy | Negligible correlation between clothing texture and accuracy, confirming robustness across different clothing types. |
| Performance Under Limiting Conditions (for conditions where motion is not intended use) | Motion: Up-and-down or back-and-forth motion increased errors; left-and-right motion had the least impact. (Device is not intended for motion conditions). |
| Behavior: Coughing caused significant errors; shallow breathing had minimal effect. | |
| User Pose: No difference in accuracy between sitting or lying positions. | |
| Illumination: Stable performance across various lighting conditions. | |
| Measurement Distance: Accuracy reliable within 1.5 meters but decreased beyond. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 420 participants
- Data Provenance:
- Country of Origin: Taiwan (377 subjects) and United States (43 subjects)
- Retrospective or Prospective: Not explicitly stated as retrospective or prospective, but the description of "evaluation in a clinical study involving 420 participants" generally implies a prospective collection for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information regarding the number of experts used or their qualifications for establishing the ground truth. It states that the ground truth was established by a "gold standard etCO2 device (manually counted/annotated respiratory rate from analysis of waveform output from the Philips MX100 with Microstream CO2 Extension)." This suggests that human expert annotation may have been involved in the manual counting/annotation, but the specifics are not detailed.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (such as 2+1, 3+1, none) for the test set. The ground truth was derived from a direct comparison to a gold standard medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study's focus was on the standalone performance of the FH Vitals SDK-RR against a gold standard, not on the improvement of human readers with AI assistance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone study was done. The entire clinical performance summary describes the FH Vitals SDK-RR (algorithm only) processing video input to measure respiratory rates and comparing these measurements directly against a gold standard device, without human intervention in the measurement process itself.
7. The Type of Ground Truth Used
The ground truth used was a gold standard etCO2 device, specifically the "manually counted/annotated respiratory rate from analysis of waveform output from the Philips MX100 with Microstream CO2 Extension." This is a form of physiological measurement data, potentially with human expert review/annotation of that waveform.
8. The Sample Size for the Training Set
The document does not provide any information about the sample size used for the training set. The descriptions are exclusively for the clinical performance study (test set).
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established, as the training set details are not included.
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(270 days)
FaceHeart Vitals Software Development Kit (FH vitals SDK)
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.
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