(269 days)
VitalSigns Camera Medical Library is a software library that can be integrated into a customer application for use during virtual consults or health screening. It is intended for spot checking of Respiration Rate (RR) in an automatic contactless manner as a data point in the overall assessment of the patient. It is used under the supervision of a health care professional, either in the home or in a clinical environment when the subject is still and positioned properly in front of the camera (Samsung Galaxy A20e), which is placed on a stable surface in an adequately lit environment.
It is intended to be used on patients aged 22 years and older that classify as ASA I (American Society of Anesthesiologists), which is defined as a normal healthy patient, non-smoking and no or minimal alcohol use.
It is not intended for continuous patient monitoring system or as the sole method of checking the physical health of the patient, nor as an apnea monitor, but as a part of a framework which mandates periodic checks by a health care professional to ensure appropriate clinical diagnosis and treatment can be reached.
The Philips VitalSigns Camera Medical Library (hereafter known as Philips VSC-MEDlib) is a software library that shall be used in conjunction with a camera which can be part of another platform or as part of a medical device. The Philips VSC-MEDlib incorporates an algorithm which allow for automatic, contactless measuring of Respiration Rate (RR). Philips VSC-MEDlib utilizes the video stream of an unobstructed view of the subject's torso captured from a camera to calculate the RR from torso motion. The video stream can be captured during a video consult or health screening which should always be conducted in the presence of a physician or other Health Care Professional (HCP). The patient must be properly positioned in front of the camera, sitting still and in an adequately lit environment. From a video stream that typically lasts 60 seconds or less, a spot measurement is taken.
Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) clearance letter:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria (from Predicate Device/Indication) | Reported Device Performance (Philips VitalSigns Camera Medical Library) |
|---|---|---|
| Respiration Rate (RR) Measurement Range | 8-25 bpm (Predicate Device: Thora-3Di, Model T-01) | 7-30 bpm (Substantially Equivalent) |
| Accuracy (Error/Tolerance) | ±2 bpm (Predicate Device: Thora-3Di, Model T-01) | RMSE was 0.80 [95% CI = 0.582 – 1.017], which meets the primary endpoint of ≤ 3 BPM. (Meets Criteria) |
| Measurement Window | 60 seconds (Predicate Device: Thora-3Di, Model T-01) | 60 seconds (Same) |
| Successful Measurement Rate | Not explicitly stated as an acceptance criterion for the predicate, but implied by performance. | VSC-MEDlib provided a RR output for 83 subjects (93.3% of 92 enrolled). |
Note: While the predicate device had an accuracy of ±2 bpm, the Philips VSC-MEDlib's stated primary endpoint (acceptance criterion) for RMSE was ≤ 3 BPM, which it met. This suggests a slightly less stringent accuracy requirement for the new device, but the FDA still deemed it substantially equivalent based on the overall package of evidence.
2. Sample Size and Data Provenance
- Test Set Sample Size: 92 subjects were enrolled in the prospective clinical investigation. VSC-MEDlib provided a RR output for 83 subjects (93.3%).
- Data Provenance: Single center, prospective clinical investigation conducted in the Netherlands. The study explicitly states the subject population was representative of the intended U.S. population and evaluated performance under suboptimal conditions.
3. Number of Experts and Qualifications for Ground Truth
- The document states that the gold standard reference device was manually annotated capnography. It does not specify the number of experts or their qualifications for this manual annotation.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method for establishing the ground truth. It simply states "manually annotated capnography" was used as the gold standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. The study focused on the standalone performance of the device against a gold standard, not on how human readers' performance might improve with AI assistance.
6. Standalone Performance
- Yes, a standalone (algorithm only, without human-in-the-loop performance) study was performed. The clinical investigation directly evaluated the Philips VSC-MEDlib's accuracy in measuring RR against a gold standard reference.
7. Type of Ground Truth Used
- The ground truth used was manually annotated capnography. This is considered a gold standard for respiration rate measurement.
8. Sample Size for the Training Set
- The document does not provide the sample size used for the training set. It only details the clinical investigation used for performance evaluation (test set).
9. How the Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth was established for the training set. This is a common omission in 510(k) summaries, which tend to focus on the validation/test set performance.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).