(233 days)
The Upper Arm Blood Pressure Monitor, Model BP3KV1-5W is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm for a circumference range from 22 to 52cm.
The device is suitable for use by adults with conditions of diabetes, pregnancy, or pre-eclampsia.
The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.
The device can be used in connection with a smart phone via Bluetooth or with a personal computer (PC) via USB. The measurement data can be transferred to a smart phone running the Microlife Connected Health+ mobile software (App) or a PC running the Microlife BP Analyzer+ (BPA+) software.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 22 -52 cm by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but using a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".
The device detects the appearance of irregular heartbeat during measurement, and the symbol " "\\ "is displayed after the measurement. In addition, the device can be used in connection with smart mobile devices running the APP and via Bluetooth.
The blood pressure monitor is a fully automatic digital blood pressure measuring device use by adults on the upper arm at home.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (ANSI/AAMI/ISO 81060-2:2019) | Reported Device Performance (Microlife BP3KV1-5W, validated via BP3KT1-3N) |
|---|---|---|
| Blood Pressure Accuracy | Sphygmomanometer against auscultatory measurement: | |
| • Mean difference (device - reference) ≤ ± 5 mmHg. | ||
| • Standard deviation of differences ≤ 8 mmHg. | ||
| • For at least 85% of subjects, the absolute difference between device and average auscultatory readings must be ≤ 5 mmHg. | Passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 test standard. | |
| Pulse Rate Accuracy | ± 5% of the reading | ± 5% of the reading (stated as identical to BP3KT1-3N) |
| Pressure Resolution | 1 mmHg | 1 mmHg (stated as identical to BP3KT1-3N) |
| Measuring Range (SYS) | 60-255 mmHg | 60-255 mmHg (stated as identical to BP3KT1-3N) |
| Measuring Range (DIA) | 40-200 mmHg | 40-200 mmHg (stated as identical to BP3KT1-3N) |
| Measuring Range (Pulse) | 40 to 199 beats per minute | 40 to 199 beats per minute (stated as identical to BP3KT1-3N) |
| Overall Clinical Validation Outcome | Device passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 test standard for accuracy. | Passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 test standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that a clinical study was conducted using the BP3KT1-3N (European Device) for validation. This study was a "prospective, open-label, non-randomized, single-center validation study." The study followed the ANSI/AAMI/ISO 81060-2:2019 test standard.
While the exact sample size for the test set is not explicitly stated in the provided text, the ANSI/AAMI/ISO 81060-2:2019 standard typically requires a minimum of 85 subjects for validation of blood pressure devices (as referenced in the acceptance criteria regarding absolute differences).
The data provenance is prospective, single-center, and from a European Device (BP3KT1-3N). The specific country is not mentioned beyond "European Device."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing the ground truth. However, for a clinical validation study following the ANSI/AAMI/ISO 81060-2:2019 standard, the ground truth for blood pressure measurements is typically established by at least two trained observers (experts) using a mercury sphygmomanometer or an equivalent reference device, meticulously following standardized auscultatory procedures. These observers are usually trained and certified in blood pressure measurement techniques.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method. In clinical validation studies conforming to the ANSI/AAMI/ISO 81060-2 standard, when multiple observers are used for ground truth, a common adjudication method involves taking the average of the observers' readings, or in cases of significant discrepancy, a third observer might be used to mediate or resolve differences. The standard itself outlines specific requirements for how observer readings should be handled.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. The provided information describes a clinical validation study for the device's accuracy against a reference standard, not a study comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done for the blood pressure measurement component. The clinical study for the BP3KT1-3N device validated its accuracy according to the ANSI/AAMI/ISO 81060-2:2019 standard. This standard assesses the device's ability to accurately measure blood pressure on its own, without direct human interpretation or modification of the measurement itself during the process (though a human activates the device and applies the cuff). The study concluded that "The Microlife device has passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 test standard," which is a testament to its standalone measurement accuracy.
7. The Type of Ground Truth Used
The ground truth used for the clinical validation study was auscultatory measurement (reference sphygmomanometry). This is implied by the ANSI/AAMI/ISO 81060-2:2019 standard which compares the automated device's readings against a series of auscultatory measurements by trained observers.
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set. The clinical study mentioned is a validation study, which typically involves a separate set of subjects from any training data used for algorithm development.
9. How the Ground Truth for the Training Set was Established
The document does not provide information on how the ground truth for the training set was established, as details about the training process and data are not included.
§ 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).