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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

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.

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GX1-5X (BP A3 PC) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual of 12 years and older, with arm circumference sizes ranging from 22 -52 cm by using a non-invasive oscillometric technique in an inflatable cuff being wrapped around the upper arm.

The device is also validated for all adult diabetic users.

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 your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with PC.

The blood pressure monitor is a fully automatic digital blood presure measuring device for use by adults (also applicable for diabetic patients) on the upper arm at home or in your doctor's/nurse's office.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GX1-5X (BP A3 PC) is designed to measure systolic and diastolic blood pressure, pulse rate of an adult 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 use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert 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 " memory data can be transferred to the PC (personal computer) running the Microlife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable. The device is also validated for all adult diabetic users. The blood pressure monitor is a fully automatic digital blood pressure measuring device for use by adults(also applicable to the diabetic patients) on the upper arm at home or in your doctor's/nurse's office.

The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GX1-5X (BP A3 PC), aims to measure systolic and diastolic blood pressure and pulse rate in adults aged 12 and older, with arm circumferences from 22-52 cm, using a non-invasive oscillometric technique. It also detects irregular heartbeats and is validated for all adult diabetic users.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Sizes:
  • K172880 (Predicate Device Study): The original clinical validation study covered ages 56 years and older. The exact number of subjects is not provided in the K183469 document, but it is implied to be sufficient for ISO 81060-2 compliance for that age group.
  • K183469 (Subject Device Study): An additional clinical validation study was conducted using 39 subjects covering ages 22 years to 55 years old.
  • Combined Study: When results from both K172880 and K183469 are combined, the total sample size covers adults aged 22 years and older. The total number of subjects is not explicitly stated as a single sum, but it's the sum of subjects from both studies.
• Data Provenance: The document does not explicitly state the country of origin for the data. The studies were retrospective or prospective is not stated, but given they are clinical validation studies for device approval, they would typically be prospective.

3. Number of Experts and their Qualifications for Ground Truth

The document states that the clinical validation was conducted in compliance with ANSI/AAMI/ISO 81060-2. This standard requires the use of trained observers to take reference blood pressure measurements. While the exact number and detailed qualifications of these "experts" (observers) are not specified in this FDA summary, compliance with ISO 81060-2 implies that:

• Multiple observers were used (usually at least two per subject).
• These observers were trained and certified in auscultatory blood pressure measurement techniques. Their qualifications would typically involve extensive experience and demonstrated proficiency in taking accurate manual blood pressure readings, ideally from a clinical setting.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for disagreements between observers. However, compliance with ANSI/AAMI/ISO 81060-2 dictates that a robust methodology is used to establish reference blood pressure. This typically involves:

• Simultaneous measurements by at least two trained observers (often blinded to each other's readings).
• A mechanism to handle discrepancies, such as averaging readings that are within a certain tolerance, or having a third observer adjudicate if discrepancies exceed a defined threshold. The standard itself specifies criteria for acceptable differences between observers.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The study focuses on the standalone performance of the blood pressure monitor against reference measurements, not on how human readers' performance improves with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone (algorithm only, without human-in-the-loop performance) study was conducted. The clinical validation studies (both K172880 and the additional K183469 study) assess the accuracy of the device's measurements against reference measurements taken by trained observers, demonstrating the algorithm's performance.

7. Type of Ground Truth Used

The ground truth used was expert consensus / reference measurements from trained observers. This is explicitly stated by the compliance with ANSI/AAMI/ISO 81060-2, which relies on simultaneous auscultatory measurements by trained personnel as the gold standard for blood pressure.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. This is typical for medical devices that utilize established oscillometric algorithms, where proprietary development data (often from extensive internal testing and algorithm tuning) is not disclosed in K numbers. The focus of the 510(k) submission is on the clinical validation (test set performance).

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

Information on how the ground truth for the training set was established is not provided in this document. As mentioned above, the training data and its ground truth establishment are typically part of the manufacturer's proprietary development process and are not detailed in the FDA 510(k) summary. However, for blood pressure monitors, training data would typically involve a large dataset of oscillometric waveforms paired with simultaneously obtained auscultatory reference measurements from human observers.

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