(309 days)
The Philips wearable biosensor-G5 is indicated for single patient use whenever heart rate measurement is needed in noncritical hospital settings. The Philips wearable biosensor-G5 solution is used as a higher resolution heart rate log by nurses or physicians retrospectively as an aid in making non-ife threatening therapeutic decisions. The biosensor is intended for patients who are 18 years of age or older.
The G5 Biosensor is intended only for patients with a baseline narrow QRS complex (less than 100 ms).
Philips wearable biosensor-G5 Solution is a physiological sensing solution that gathers and stores a patient's heart rate. Philips wearable biosensor-G5 Solution is comprised of the:
- Philips wearable biosensor-G5
- and data visualization application "G5 application" ●
The Philips wearable biosensor-G5 is a battery operated, single-use device, measuring heart rate by continuously acquiring surface electrical waveforms related to cardiac excitations and measuring beat-to-beat intervals when a patient is stationary or ambulatory. The sensor functions by capturing and then sending physiological data wirelessly to the software application. The sensor's frequency of data collection and transmission is configurable. The G5 application receives and displays data from the Philips wearable biosensor-G5 providing a user interface and exportable file for retrospective review and analysis.The G5 Biosensor is intended only for patients with a baseline narrow QRS complex (less than 100 ms).
The Philips wearable biosensor-G5 Solution is a physiological sensing solution that measures heart rate by continuously acquiring surface electrical waveforms and beat-to-beat intervals.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Heart Rate Resolution | ±1 bpm |
| Heart Rate Range | 30 - 220 bpm (vs. Predicate: 30 - 240 bpm) |
| Heart Rate Accuracy | Meets IEC 60601-2-27 and IEC 60601-2-47 |
| Operational Relative Humidity Range | 15% to 95% non-condensing |
| Wear Duration | Maximum 48 hours |
| Shelf Life | 3 months |
| Biocompatibility | Complies with ISO 10993-1 (cytotoxicity, sensitization, irritation) |
| Electrical Safety & EMC | Complies with IEC 60601-1, IEC 60601-2-27, and IEC 60601-1-2 |
| Software Verification & Validation | Complies with FDA guidance for "moderate" level of concern software |
| Adhesive Performance | Complies with ANSI/AAMI EC12:2000/(R) 2010 |
2. Sample Size Used for the Test Set and Data Provenance:
- Wear Duration Study: 28 normal healthy volunteers.
- Data Provenance: The text does not explicitly state the country of origin. The study appears to be prospective due to its nature of testing volunteers for wear duration.
- Other Performance Testing: The text does not specify sample sizes for biocompatibility, electrical safety, EMC, or general performance bench testing. These typically involve laboratory tests on devices rather than human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Wear Duration Study: The text does not specify the number or qualifications of experts for establishing ground truth regarding adhesive performance or wear duration. The assessment for adhesive performance was "calculated per the ANSI/AAMI EC12:2000/(R) 2010 Disposable ECG Electrodes," suggesting adherence to a recognized standard rather than expert consensus on individual cases.
- Heart Rate Accuracy: For heart rate accuracy, the text refers to compliance with IEC standards (IEC 60601-2-27, IEC 60601-2-47), which imply a standardized testing methodology for accuracy rather than expert adjudication of ground truth for each measurement.
4. Adjudication Method for the Test Set:
- The text does not mention an explicit adjudication method (like 2+1 or 3+1) for any of the studies. This suggests that the performance metrics were determined through standardized testing protocols (e.g., against reference measurements for heart rate) or direct measurement against a defined standard (e.g., ANSI/AAMI EC12 for adhesive performance).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a "multi-reader multi-case (MRMC) comparative effectiveness study" comparing human readers with and without AI assistance was not done. The device is a biosensor that measures heart rate, not an AI-assisted diagnostic imaging or interpretation tool that would typically involve human readers.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
- Yes, the performance data presented primarily reflects the standalone performance of the device.
- The "Performance Testing bench testing" using voluntary standards like IEC 60601-2-27 and IEC 60601-2-47 directly assesses the algorithm's ability to accurately measure heart rate in a controlled setting.
- The "Wear Duration Study" also assesses the physical performance of the biosensor itself.
- The "Software Verification and Validation Testing" is also a standalone assessment of the software's functionality.
7. Type of Ground Truth Used:
- Heart Rate Accuracy: The ground truth for heart rate accuracy would likely be established by a highly accurate reference standard heart rate monitor or ECG system as specified by the IEC 60601-2-27 and IEC 60601-2-47 standards.
- Adhesive Performance: The ground truth for adhesive performance was established through calculation "per the ANSI/AAMI EC12:2000/(R) 2010 Disposable ECG Electrodes," which is a recognized standard for evaluating such performance.
- Biocompatibility: Ground truth is established by the outcomes of standardized biological tests (cytotoxicity, sensitization, irritation) against defined acceptable limits.
8. Sample Size for the Training Set:
- The document does not provide any information regarding a training set sample size. This suggests that the device's algorithms for heart rate detection might be based on established physiological principles and signal processing techniques rather than a machine learning model that requires explicit training on a large dataset mentioned in this summary.
9. How the Ground Truth for the Training Set was Established:
- As no training set is mentioned, this information is not provided. If the device uses algorithms that were developed and validated internally, the "ground truth" for their development would involve a similar process of comparing algorithm outputs against known, accurate physiological signals under controlled conditions, but the document does not elaborate on this developmental phase.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).