(88 days)
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
| Acceptance Criteria (from ISO 81060-2) | Reported Device Performance (Combined K172880 & K183469 Studies) |
|---|---|
| Criterion 1: Mean difference between device and reference measurements for systolic and diastolic blood pressure should be $\leq$ 5 mmHg. | The study results for both systolic and diastolic blood pressure were found to be "passing" and "compatible with ISO 81060-2," implying that this criterion was met. |
| Criterion 2: Standard deviation of the differences between device and reference measurements for systolic and diastolic blood pressure should be $\leq$ 8 mmHg. | The study results were found to be "passing" and "compatible with ISO 81060-2," implying that this criterion was met. |
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.
§ 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).