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Digital Automatic Blood Pressure Monitor BPM03 Series is for use by medical professional or at home. The BPM03 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm of an individual. The inflatable cuff circumference is limited to 17cm – 44cm via 3 different size of cuff. 3 different cuff sizes are 17-22cm, 22-32cm and 32-44cm.

Digital Automatic Blood Pressure Monitor BPM03 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual in each measurement and then displays the readings on a digital panel.

The BPM03 Series utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for the blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movements into a digital reading.

Here's an analysis of the acceptance criteria and study information for the Digital Automatic Blood Pressure Monitor BPM03 Series, based on the provided text:

Acceptance Criteria and Device Performance Study

The submission states that the Digital Automatic Blood Pressure Monitor BPM03 Series meets the requirements of ANSI/AAMI SP-10-2002. This standard defines the performance, accuracy, and clinical validation requirements for automated sphygmomanometers. While the document doesn't explicitly list specific numerical acceptance criteria (e.g., mean difference and standard deviation for blood pressure readings), compliance with ANSI/AAMI SP-10-2002 implies adherence to its specified limits for accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided text.
• Data Provenance: Not explicitly stated. The document mentions "A systematic & independent clinical test was conducted," but does not specify the country of origin or whether it was retrospective or prospective.

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

• Number of Experts: Not explicitly stated in the provided text.
• Qualifications of Experts: Not explicitly stated. For a clinical validation study adhering to ANSI/AAMI SP-10-2002, the ground truth (reference blood pressure measurements) would typically be established by two or more trained observers (experts) using a mercury sphygmomanometer or an equivalent reference device, following a standardized protocol. These observers would be trained and certified in blood pressure measurement techniques.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. In clinical validation studies for blood pressure monitors, if multiple observers are used, their readings are usually averaged or adjudicated if there are discrepancies beyond a certain threshold.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a standalone blood pressure monitor and does not involve AI assistance for human readers in interpreting results.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• Standalone Performance Study: Yes, a standalone performance study was conducted. The "systematic & independent clinical test" was performed to validate the performance of the Digital Automatic Blood Pressure Monitor BPM03 Series, which operates as an algorithm-only device (oscillometric method) to determine blood pressure and pulse rate without human oversight or interpretation of results beyond reading the displayed values.

7. The Type of Ground Truth Used

• Type of Ground Truth: Although not explicitly stated as "ground truth," the clinical test was conducted to validate the device's performance against the requirements of ANSI/AAMI SP-10-2002. This standard mandates validation against simultaneous auscultatory blood pressure measurements performed by trained observers using a reference device (e.g., mercury sphygmomanometer). Therefore, the ground truth would have been established by expert auscultatory measurements.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The document describes a "clinical test" for validation, not a study involving machine learning model training. The device uses an oscillometric methodology, which is a well-established algorithm for blood pressure measurement rather than a machine learning model that requires a training set.

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 training set for a machine learning algorithm. The oscillometric algorithm itself is based on pneumatic and physiological principles.

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