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Digital Automatic Blood Pressure Monitor BPM11 Series is for use by medical professional or at home. The BPM11 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 BPM11 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 BPM11 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 a summary of the acceptance criteria and study information for the Digital Automatic Blood Pressure Monitor BPM11 Series, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state the sample size of the test set or the country of origin of the data. It only mentions that "A systematic & independent clinical test was conducted." It also doesn't specify if the study was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

The document does not specify the number of experts used or their qualifications for establishing the ground truth for the clinical test.

4. Adjudication Method for the Test Set:

The document does not describe the adjudication method used for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance study was conducted. The clinical test evaluated the performance of the device itself (the algorithm/hardware combined) in measuring blood pressure and pulse rate, independent of human interpretation or assistance. The device operates automatically.

7. Type of Ground Truth Used:

The type of ground truth used is not explicitly stated, but for blood pressure monitor validation against a standard like ANSI/AAMI SP-10, the ground truth is typically established by simultaneous measurements using a reference method (e.g., a mercury sphygmomanometer with auscultation by trained observers), compared against the device's readings.

8. Sample Size for the Training Set:

The document does not mention a training set or any details about it. This suggests that the device's algorithm might be based on established physiological principles and calibrated, rather than being a machine learning model that requires a distinct training phase with labeled data in the way a diagnostic AI typically would.

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

As no training set is mentioned, information on how its ground truth was established is not provided.

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