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The Wrist-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age.

The Wrist-type Fully Automatic Digital Blood Pressure Monitor is consist of sphygmomanometer main body and cuff. The mainbody contains ABS housing, LCD, keys, measurement control module, pneumatic control module, power supply module. The Wrist-type Fully Automatic Digital Blood Pressure Monitor is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment. The device with an inflatable cuff wrapping around the patient's wrist and 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 minutes. The cuff can measure pressure range from 0 to 300mmHg, and the pulse rate range from 30 to 180 beats/min.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the ISO 81060-2:2018+AMD2020 standard for clinical investigation of automated noninvasive sphygmomanometers.

Conclusion: Both tested models (DBP-2208 and DBP-2242) met all specified acceptance criteria according to both Method 1 and Method 2 of ISO 81060-2:2018+AMD2020.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 85 patients for each clinical investigation (one for cuff 13.5-21.2cm using DBP-2208 as representative, and one for cuff 12.5-23cm using DBP-2242 as representative). Each group comprised 43 females and 42 males.
• Data Provenance: The document does not explicitly state the country of origin. It describes clinical studies conducted on "patients" and "subjects" indicating prospective data collection. "All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document states that a "manual Mercury Sphygmomanometer was used as a reference device" to establish the ground truth. It does not explicitly mention the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, for a clinical study involving a mercury sphygmomanometer as the reference, it is implied that trained medical professionals would perform these measurements. The standard ISO 81060-2 typically requires measurements by qualified observers.

4. Adjudication Method for the Test Set

The adjudication method described is the "Same wrist sequential method." This means the device under test and the reference device (manual Mercury Sphygmomanometer) measurements were taken sequentially on the same wrist. The document does not specify a separate "adjudication" process involving multiple experts reviewing discrepancies, but rather a direct comparison to the reference device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the accuracy of the device itself compared to a reference standard, not on how human readers' performance might improve with AI assistance. This is a standalone device accuracy study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this was a standalone performance study. The "Wrist-type Fully Automatic Digital Blood Pressure Monitor" is an automated device designed to measure blood pressure. The clinical investigations directly assessed the device's accuracy against a manual reference without human intervention in the measurement process (other than proper placement and initiation).

7. Type of Ground Truth Used

The ground truth used was established by a manual Mercury Sphygmomanometer. This is considered a gold standard for blood pressure measurement in clinical studies.

8. Sample Size for the Training Set

The document does not provide any information about a training set. This is a validation study for a medical device's accuracy, not an AI/machine learning algorithm that typically requires a training set. The device determines blood pressure using an oscillometric method based on pre-programmed algorithms and hardware.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI/machine learning algorithm is mentioned in the document.

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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):

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.

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