Search Results

This blood pressure monitor is intended to be used to measure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.

Bluetooth Blood Pressure Monitor, BPW1 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, including irregular heartbeats (IHB) from the wrist. The device is powered by a rechargeable Lithium battery. The device has an START/STOP button for starting the measurement and stopping the measurement at any time when measuring. The MEM button is for displaying the last measurement. The device can also connect the mobile platform with an MMA (mobile medical application) as its accessory which can start/stop the device through Bluetooth 4.0. An irregular heartbeats rhythm is defined as a rhythm that varies by 25% less or more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.

The provided text describes the submission of a 510(k) premarket notification for a "Bluetooth Blood Pressure Monitor, BPW1" and its substantial equivalence to a predicate device. It details various performance tests conducted, including safety, EMC, reliability, and biocompatibility. However, it does not contain the specific acceptance criteria for the device's performance (e.g., blood pressure accuracy in mmHg or pulse accuracy in bpm), nor does it provide the detailed study results that prove the device meets these criteria in a quantitative manner.

Instead, the document states that the device was tested according to relevant standards (e.g., IEC 80601-2-30, ISO81060-2:2013) and that it "met all relevant requirements" or "achieved the requirements." It also states "The evaluation of these results present no new issues related to safety or effectiveness." This indicates that the study was performed, and the results were deemed acceptable, but the specific numerical performance data and detailed acceptance thresholds are not included in this summary.

Therefore, for aspects requiring quantitative data (like specific accuracy tolerances and achieved performance), the information is implicitly covered by conformance to standards, but not explicitly stated.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Note: The "Accuracy" values (Static Pressure: ± 3mmHg, Pulse: ± 5% reading value) are explicitly stated in the "Comparison of Technological Characteristics" table under the "Accuracy" row for both the predicate and modified device. This implies they are the expected performance standard and likely the acceptance criteria for those specific parameters. The broader "Reported Device Performance" for other categories is a general statement of compliance with standards, as detailed numerical results are not included.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The text clearly mentions "Clinical Validation: ISO81060-2:2013 Non-invasive sphygmomanometers —Part 2: Clinical validation of automated measurement type." This standard specifies requirements for the number of subjects and measurements for clinical validation. While the exact number of subjects is not stated in this document, it implies that the sample size adhered to the ISO 81060-2:2013 standard. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For a blood pressure monitor, the ground truth for clinical validation is typically established by trained observers using a reference measurement method (e.g., auscultation with a sphygmomanometer). The ISO 81060-2 standard outlines requirements for such observers, but the specific details are not in this text.

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 clinical validation, ground truth primarily relates to the reference measurement method (e.g., mercury sphygmomanometer with trained observers), rather than expert adjudication of AI output.

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 device is a blood pressure monitor, not an AI-based imaging diagnostic tool that typically involves human readers. Therefore, an MRMC study is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the clinical validation study conducted per ISO 81060-2:2013 is a standalone performance test of the device (its algorithm) against a reference standard. The document states, "The device has achieved the requirements of ISO18060-2:2013," which indicates its standalone performance against a clinical reference.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the clinical validation of the blood pressure monitor, the ground truth would be established through simultaneous or closely sequential measurements using a validated reference method, typically auscultation by trained observers with a mercury sphygmomanometer or another precisely calibrated and validated reference device, as specified by ISO 81060-2:2013. This is implicitly the "ground truth" against which the device's measurements are compared.

8. The sample size for the training set:
This device is a traditional oscillometric blood pressure monitor, not a machine learning/AI device requiring a separate "training set" in the conventional sense of AI model development. Therefore, this concept is not applicable in the context presented. The "training" for such devices is inherent in their design and calibration processes, not a distinct data set for algorithm training.

9. How the ground truth for the training set was established:
As explained in point 8, the concept of a separate "training set" with established ground truth as used in AI/ML is not applicable to this type of medical device based on the information provided.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

BW-BW1 Bluetooth Blood Pressure Monitor is intended to measure blood pressure (systolic and diastolic) and heart rate from the wrist using the oscillometric method, the measured data is transferred to a smart phone for the patient record archiving and/or measured data analysis purpose.

The device is intended for use in only adult population, not applied to the other populations such as neonatal baby.

It can not be used while the wrist (arm) has bleeding or wound the blood flowing from the wound in pressurizing.

Not Found

This document is a 510(k) premarket notification for the BW-BW1 Bluetooth Blood Pressure Monitor. It primarily consists of regulatory correspondence and an "Indications for Use" statement, and does not contain the detailed study information needed to answer the request.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them, because this document does not include that data. This document only states that the device is "substantially equivalent" to predicate devices, which is part of the regulatory approval process but doesn't detail performance studies.

Ask a specific question about this device