(144 days)
The device are digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging form 5 3/8 inches to 7 2/3 inches (13.5cm to 19.5cm) .
The devices detect the appearance of irregular heatbeats during measurement and gives a warning signal with readings.
The Wrist Blood Pressure Monitor (model: W203,W202,W1681) are battery-powered, automatic, non-invasive blood pressure system intended for home use. The Wrist Blood Pressure Monitor (model: W203,W202,W1681) are intended for use in adult patient population with wrist circumference ranging from 5 3/8 inches to 7 2/3 inches (13.5 cm). These devices are powered by 2 X AAA battery. The device wrist cuff inflates using an integral pump and deflates via an electric valve. During inflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 295 mmHg, and the pulse rate range from 40 to 195 beats/min. When the device detected irregular rhythms, " Y " will display on screen. An irreqular heartbeat rhythm is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while your monitor is measuring blood pressure. The WHO blood pressure indicator bar can classify by WHO and ISH recommendation. The devices display the latest blood pressure reading, while up to 2) 99 readings can be stored in memory.
The provided text describes the acceptance criteria and a study proving that the device meets these criteria. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for accuracy are derived from ISO 81060-2:2013, which is referenced for the clinical study. The specific criteria are:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of Pressure: ±3mmHg | ±3mmHg |
| Accuracy of Pulse Rate: ±5% of reading | ±5% of reading |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "clinical accuracy should be checked by application of the tests of ISO 81060-2:2013, we conducted the the clinical study in accordance with this standard." ISO 81060-2 specifies subject recruitment criteria but not a fixed sample size for all studies.
- Data Provenance: Not explicitly stated. However, since Shenzhen Yuezhongxing Technology Co., Ltd. is based in China, it is reasonable to infer the data provenance is likely China, and the study was conducted to support their submission to the FDA, suggesting a prospective design for regulatory purposes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not available in the provided text, as the device is a blood pressure monitor, not an AI diagnostic tool requiring expert interpretation for ground truth. Blood pressure monitors establish ground truth through direct physical measurements (e.g., using a auscultatory reference method against which the oscillometric device is compared).
4. Adjudication Method for the Test Set
This information is not available in the provided text. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image analysis or subjective interpretations, which is not applicable to a blood pressure monitor's accuracy testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- Was it done? No. MRMC studies are relevant for evaluating AI systems with human interaction. This device is a standalone blood pressure monitor and does not involve human readers in the output interpretation in the manner an AI diagnostic system would.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, a standalone performance evaluation was done. The device (Wrist Blood Pressure Monitor) operates independently to measure blood pressure and pulse rate. Its accuracy was tested against established standards (ISO 81060-2:2013, which describes clinical validation of automated sphygmomanometers).
7. The Type of Ground Truth Used
The ground truth for blood pressure monitor accuracy studies typically involves:
- Simultaneous auscultatory measurements performed by trained observers (manual sphygmomanometry) as a reference method, as prescribed by standards like ISO 81060-2.
- Comparison of the device's readings against these reference measurements to determine accuracy.
8. The Sample Size for the Training Set
This information is not available in the provided text. Blood pressure monitors, especially those using oscillometric methods, are typically designed based on physics and signal processing principles rather than extensive machine learning "training sets" in the modern AI sense. While there might be internal development and calibration data, it's not described as a "training set" like in deep learning models.
9. How the Ground Truth for the Training Set was Established
This information is not available in the provided text, and the concept of a "training set" and "ground truth" in that context is not directly applicable to a traditional blood pressure monitor as it would be for an AI-powered diagnostic device. Device calibration and validation would typically involve reference measurements against known standards.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).