(158 days)
This product is intended to measure the blood pressure and pulse rate of adult more than 12 years old and with wrist circumference ranging from 13.5 cm at household or medical center (not suitable for neonate, pregnancy or pre-eclampsia.)
The YUWELL® Blood Pressure Monitor (Model: YE8800AR, YE8800CR) is a rechargeable lithium battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system intended for over-the-counter (OTC) use. YE8800AR, YE8800CR is designed for wrist circumference ranging from 13.5 cm to 19.5 cm. The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an air pump and deflates via an exhaust valve. During inflation, the cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure.
The acceptance criteria for the YUWELL® Electronic Blood Pressure Monitor (Model: YE8800AR, YE8800CR) are primarily based on performance standards for blood pressure monitors. The study described is a clinical accuracy test.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Standard) | Reported Device Performance (YUWELL® Electronic Blood Pressure Monitor) |
|---|---|
| Accuracy of Pressure Indicator (per ANSI/AAMI/ISO 81060-2:2018 Criterion 1) | Mean Difference ± Standard Deviation (Test Device vs. Reference BP): |
| Systolic: -1.7 ± 5.66 mmHg | |
| Diastolic: -1.0 ± 5.66 mmHg | |
| (The full criteria for ANSI/AAMI/ISO 81060-2 require that the mean difference be ≤ ±5 mmHg and the standard deviation be ≤ 8 mmHg.) | |
| Accuracy of Pressure Indicator (per ANSI/AAMI/ISO 81060-2:2018 Criterion 2) | Mean Differences (Two Observers vs. YUWELL® Electronic Blood Pressure Monitor): |
| Systolic: -1.7 ± 4.17 mmHg | |
| Diastolic: -1.0 ± 4.99 mmHg | |
| (The full criteria for ANSI/AAMI/ISO 81060-2 for Criterion 2 states that the standard deviation of the differences between the observation and the device should be not greater than 6.91 mmHg for at least two out of three device criteria sets. Values are generally expected for pairs of subjects, not for the entire population at once as given above) | |
| Accuracy of Pulse Rate | Within ±5% of reading |
| Electrical Safety (IEC 60601-1, IEC 60601-1-11, IEC 80601-2-30) | Complies |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies |
| Usability (IEC 60601-1-6, IEC 62366) | Complies |
| Software Verification and Validation (FDA Guidance, IEC 62304) | Complies |
| Biocompatibility (ISO 10993, FDA Guidance) | Complies |
| FCC Compliance (Part 15 federal communications commission rules) | Complies |
The Study Proving Acceptance Criteria:
A clinical accuracy test was conducted on the Yuwell YE8800AR model.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 85 participants.
- Data Provenance: The document does not explicitly state the country of origin. It describes participants as the "general population." The study is described as a "clinical accuracy test," suggesting a prospective collection of data for this validation.
3. Number of Experts and Qualifications for Ground Truth:
The document mentions "reference BP" and "two observers" in relation to the ANSI/AAMI/ISO 81060-2:2018 protocol. This standard typically requires measurements by trained observers or reference devices to establish ground truth.
- Number of Experts/Observers: Two observers are explicitly mentioned in the context of Criterion 2 of the ANSI/AAMI/ISO 81060-2:2018 protocol.
- Qualifications of Experts: Not explicitly stated in the provided text, but adherence to the ANSI/AAMI/ISO 81060-2:2018 protocol implies that the observers would be appropriately trained personnel, potentially medical professionals or technicians, who follow a standardized procedure for manual blood pressure measurement to establish the reference values.
4. Adjudication Method for the Test Set:
The document does not explicitly describe an adjudication method for the test set, such as 2+1 or 3+1. The ANSI/AAMI/ISO 81060-2 standard relies on comparisons between the automated device and simultaneous auscultatory measurements performed by trained observers. Discrepancies between observers might be handled by averaging or requiring re-measurements per the standard's guidelines, but a specific "adjudication" (like a third reader resolving disagreement) is not detailed here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a standalone electronic blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance:
Yes, the described clinical accuracy test is a standalone performance test of the device (algorithm only), without a human-in-the-loop component for the measurement process itself. The "human-in-the-loop" aspect would primarily be the human observers establishing the reference blood pressure for comparison.
7. Type of Ground Truth Used:
The ground truth was established by reference blood pressure measurements, likely obtained through a standardized method such as auscultation (manual measurement with a stethoscope and sphygmomanometer) performed by trained observers, as dictated by the ANSI/AAMI/ISO 81060-2:2018 validation protocol.
8. Sample Size for the Training Set:
The document does not provide information on the sample size used for the training set. The clinical study described is for validation/testing, not for training the device's measurement algorithm. Blood pressure monitors typically rely on established oscillometric principles rather than machine learning models that require explicit "training sets" in the same way as AI diagnostic devices.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as a training set in the context of machine learning is not mentioned or implied for this type of device. The device operates based on physical principles of oscillometry. The inherent algorithm development would likely have been based on extensive physiological and engineering data, but not typically a labeled "training set" with ground truth in the AI sense.
§ 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).