(16 days)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-4A (BP A200 Comfort) is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual with arm circumference sizes ranging from 14 -52 cm by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the single upper arm.
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 the PC.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-4A (BP A200 Comfort) is designed to measure systolic and diastolic blood pressure, pulse rate of an individual 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 uses a pressure 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 " 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 provided FDA 510(k) summary for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-4A (BP A200 Comfort) includes information about clinical validation testing. However, it does not provide all the specific details requested regarding acceptance criteria, reported performance, and the full methodology of the study.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that a clinical validation was conducted in accordance with ISO 81060-2. This standard defines the accuracy requirements for automated non-invasive sphygmomanometers. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between device and reference measurements) are not explicitly stated in this summary, they are implicitly those outlined in ISO 81060-2.
The summary states: "Results were passing and the subject device was found to be substantially equivalent to the predicate device." This indicates that the device met the acceptance criteria defined by ISO 81060-2 for blood pressure measurement accuracy.
Therefore, for the table:
| Acceptance Criteria (from ISO 81060-2) | Reported Device Performance |
|---|---|
| (Not explicitly detailed in document, but implies compliance with ISO 81060-2) For example, for systolic and diastolic BP: |
- Mean difference between device and reference: ≤ ±5 mmHg
- Standard deviation of differences: ≤ 8 mmHg
(These are examples from ISO 81060-2 and might not be the exact numbers used or reported if different versions of the standard apply, but the device must meet some such criteria) | "Results were passing" |
| Irregular Heartbeat Detection Accuracy (if applicable in ISO 81060-2 for this device type) | "The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected." (No specific accuracy metrics reported here, but functionally stated as working) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical validation in accordance with ISO 81060-2.
- Sample Size: Not explicitly stated. ISO 81060-2 typically requires a minimum number of subjects (e.g., 85 subjects with specific demographic and blood pressure distribution).
- Data Provenance: Not explicitly stated. The document doesn't mention the country of origin of the data or whether it was retrospective or prospective. Clinical validation studies for device clearance are almost always prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts used to establish the ground truth.
- ISO 81060-2 typically requires measurements by multiple trained observers (e.g., at least two) to establish reference blood pressure readings using a standardized auscultatory method. These observers must be highly trained and follow strict protocols. Their qualifications are usually medical professionals with specific training in blood pressure measurement.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method.
- In clinical validation according to ISO 81060-2, the reference blood pressure is typically determined by two independent observers. If there is a significant discrepancy between their readings, a third observer might be used, or the readings might be discarded. This can be considered a form of 2-or-3 observer consensus for ground truth establishment rather than a formal "adjudication" in the AI sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not mentioned or described. The clinical validation appears to be a standalone accuracy study of the device against a reference method, not a comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes. The clinical validation study described is a standalone performance study of the device (which includes its algorithm) against a reference method (auscultatory blood pressure measurement according to ISO 81060-2). The summary focuses on the device's ability to accurately measure blood pressure.
7. Type of Ground Truth Used
The ground truth for blood pressure measurement in this context is established by expert auscultatory measurements (often referred to as a "reference standard" or "gold standard") carried out by trained observers according to strict protocols defined by standards like ISO 81060-2.
8. Sample Size for the Training Set
The document describes the submission as a 510(k) for a medical device that uses an "oscillometric method" with an algorithm to define systolic and diastolic blood pressure. It states the device "uses the same algorithm" as a predicate device. This implies the algorithm was already developed and potentially refined using historical data.
However, the summary does not provide any information about the sample size used for training this underlying algorithm. This information is typically not included in a 510(k) summary unless the AI/ML algorithm itself is novel and part of the substantial equivalence claim, requiring specific validation of its training pipeline. In this case, it appears the algorithm is considered established.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided, how its ground truth was established is also not documented in this 510(k) summary. For a blood pressure algorithm, the training set would ideally consist of blood pressure recordings (oscillometric waveforms) paired with simultaneously taken auscultatory reference measurements.
§ 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).