(266 days)
BW-BA1 Bluetooth Blood Pressure Monitor is intended to be used to measure systolic and diastolic blood pressure and heart rate from the upper arm with arm circumference ranging from 8.7 inches (approx.22 cm to 42 cm) using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a "IHB" warning signal with readings. The intended patient population of the device is only adult population aged 18 or older at home, not applied to the other populations such as neonatal baby.
It cannot be used while the arm has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The device cannot be used by pregnant patients or patients suffering from pre-eclampsia.
BW-BA1 Bluetooth Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method during inflating @ 3~8mmHg/second from about 30mmHg by inflating a cuff on the upper arm. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. An irregular heartbeat rhythm is defined as rhythm that is 25% less or 25% more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.
BW-BA1 Bluetooth Blood Pressure Monitor without any display component achieves its function by integrating the device with a collateral device iPhone, iPad with a specific mobile app to constitute a complete blood pressure measurement system. And the new device connects the mobile platform with the mobile app through Bluetooth 4.0.
The operational principle is based on oscillometric and pressure sensor technology, it can calculate the systolic and diastolic blood pressure, and the measurement results can be classified by the function of blood pressure classification indicator according to the classification rule developed by WHO.
The BW-BA1 is powered by a rechargeable Lithium battery.
The device has an ON/START button for starting the measuring and stopping the measuring at any time when measuring.
The provided text describes the 510(k) premarket notification for the BW-BA1 Bluetooth Blood Pressure Monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with acceptance criteria and device performance.
However, based on the information provided and the common requirements for blood pressure monitors, we can infer some details and highlight the missing information.
Here's an attempt to structure the answer based on your request, with a clear indication of what is not explicitly stated in the provided documents:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported device performance for blood pressure measurement accuracy. However, it does state the device's accuracy claims and mentions adherence to ISO 81060-2, which dictates such criteria.
| Acceptance Criterion (Inferred from Predicate and Standards) | Reported Device Performance (As claimed and implied by equivalence) |
|---|---|
| Blood Pressure Accuracy: Pressure (Mean Difference) | ± 3 mmHg (Claimed, consistent with predicate and standard) |
| Blood Pressure Accuracy: Pulse (Mean Difference) | ± 5% of reading value (Claimed, consistent with predicate and standard) |
| Cuff pressure range | 0~299 mmHg (Claimed for proposed device) |
| Pulse rate range | 40~180 beat/min (Claimed for proposed device) |
| Irregular Heartbeat (IHB) detection | IHB warning signal if rhythm is 25% less or 25% more than average rhythm (Proposed device feature) |
| Arm circumference range | 8.7 inches (approx. 22 cm) to 16.5 inches (approx. 42 cm) (Claimed for proposed device) |
Important Note: The document explicitly states: "Clinical validation concerning the compliance of ISO 81060-2 has been performed that the device BW-BA1 is the same as the predicate except IHB adding for our device. And the fundamental scientific technology of the device is identical with the predicate and IHB adding does not raise new questions of safety and effectiveness. Therefore the performance of the device in terms of blood pressure measurement would be identical with performance of the predicate." This implies that the device's performance is expected to meet the same accuracy standards as the predicate device, which would have been demonstrated through its own ISO 81060-2 validation. However, the direct results of this "clinical validation" for the BW-BA1 are not provided in the text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the clinical validation or the data provenance. It only mentions that "Clinical validation concerning the compliance of ISO 81060-2 has been performed." For ISO 81060-2, a typical clinical validation would involve an appropriate number of participants (e.g., generally 85 subjects with specific age and blood pressure distributions as per the standard).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For blood pressure monitor validation studies (like those following ISO 81060-2), ground truth is typically established by trained clinical professionals (e.g., physicians, nurses) using auscultatory methods with a mercury sphygmomanometer or validated reference device. The number and qualifications of these experts are usually specified in detailed study protocols, which are not included here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. For blood pressure validation studies, ground truth measurements often involve multiple observers taking readings to ensure accuracy and minimize bias, with methods for reconciling discrepant readings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable to this device. The BW-BA1 is a medical device for measuring blood pressure, not an AI-assisted diagnostic tool that would involve human readers or image interpretation. Its primary function is to accurately measure blood pressure.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicit in the independent validation of a blood pressure monitor, the device's ability to measure blood pressure accurately standalone (i.e., its algorithm for oscillometric measurement) is evaluated against a reference standard. The document mentions "Clinical validation concerning the compliance of ISO 81060-2 has been performed," which is a standalone validation of the device's measurement accuracy. The output (blood pressure readings) is then displayed via a connected app.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For blood pressure monitors, the ground truth is typically established by simultaneous measurements taken by trained observers using a calibrated reference device, such as a mercury sphygmomanometer, via the auscultatory method. This involves multiple expert readings to ensure accuracy. The document does not explicitly state this, but it is the standard for ISO 81060-2 compliance.
8. The sample size for the training set
This is not applicable as the BW-BA1 is a traditional blood pressure monitor, not an AI/machine learning-based device that typically uses "training sets" in the same way. Its fundamental operational principle is based on oscillometric and pressure sensor technology.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8. The accuracy of oscillometric blood pressure monitors is based on their physical measurement principles and calibration, validated against established clinical methods.
§ 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).