(75 days)
The Wrist-type Fully Automatic Blood Pressure Monitors BP series are intended for used by adults with 12 years and older to measure the systolic blood pressure and pulse rate.
Measure blood pressure (systolic and diastolic) and pulse rate.
The wrist-type fully automatic digital blood pressure monitors uses an inflatable cuff which is wrapped around the patient's wrist. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg. For BP-202H, BP-2208, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. BP-202H, BP-2206, BP-2208 will display an irregular heartbeat symbol " if an irregular heartbeat was detected during the measurement process. BP-2208 can display average results in three ways: the average of all measurements, the average of all AM (5:00 AM-8:59AM) measurements, and the average of all PM (18:00 PM-19:59 PM) measurements. BP-202H, BP-2206 can calculate the average of the last three measurements. In addition, BP-2208 have LCD backlight. After three minutes without operation, the blood pressure monitors turn off automatically.
Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission references the ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 standard for performance and clinical accuracy requirements. However, the document does not explicitly list the specific numerical acceptance criteria from this standard nor does it present a detailed table of the device's reported performance against these criteria. It only states:
"The test result all meet or exceed the requirement of the standards." (Non-clinical tests)
"Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10..." (Clinical tests)
To provide a hypothetical example of what such a table would look like if the specific values were provided in the submission (based on general knowledge of NIBP standards like AAMI SP10):
| Acceptance Criteria (from ANSI/AAMI SP10) | Reported Device Performance |
|---|---|
| Systematic Error (Mean Difference) | |
| Systolic BP: ≤ ±5 mmHg | (Not specified in document) |
| Diastolic BP: ≤ ±5 mmHg | (Not specified in document) |
| Random Error (Standard Deviation) | |
| Systolic BP: ≤ 8 mmHg | (Not specified in document) |
| Diastolic BP: ≤ 8 mmHg | (Not specified in document) |
| Individual Difference (Cumulative % within thresholds) | |
| % of readings within 5 mmHg: ≥ 60% | (Not specified in document) |
| % of readings within 10 mmHg: ≥ 85% | (Not specified in document) |
| % of readings within 15 mmHg: ≥ 95% | (Not specified in document) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided document. The document only mentions that "Clinical tests were performed."
- Data Provenance: Not explicitly stated. Given the manufacturer's location (Hangzhou, China), it is plausible the data was collected there, but this is not confirmed. The document does not specify if the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated. The ANSI/AAMI SP10 standard typically requires a minimum of two trained observers to establish reference blood pressure measurements.
- Qualifications of Experts: Not explicitly stated. The standard generally requires observers to be trained and validated in auscultatory blood pressure measurement using a mercury sphygmomanometer.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. For clinical validation according to ANSI/AAMI SP10, referent blood pressure is typically determined by trained observers using an auscultatory method. If multiple observers are used, their readings are usually averaged or adjudicated if they differ significantly. The document does not detail this.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, this type of study was not conducted or mentioned. The device described is an automated blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the clinical tests performed evaluate the standalone performance of the device itself (the "algorithm only," as it's an automated device). The accuracy requirements of ANSI/AAMI SP10 validate the device's ability to measure blood pressure independently.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the clinical accuracy studies (as per ANSI/AAMI SP10), the ground truth for blood pressure measurements is established by expert auscultatory measurements (typically using a mercury sphygmomanometer) conducted by trained observers.
8. The Sample Size for the Training Set
- Sample Size for Training Set: The document makes no mention of a "training set" in the context of machine learning or AI. This device is a traditional oscillometric blood pressure monitor, not an AI/ML-driven device that typically requires distinct training and testing datasets for algorithm development. The "training" of such a device is inherent in its design, calibration, and manufacturing process based on established oscillometric principles.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a separate training set or AI/ML algorithm development in the provided document. The device operates on established physiological principles and engineering.
§ 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).