Search Results

This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure on an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.

Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading. The key components of device are: a pressure sensor, an electric valve and an electronic control module together with an electric pump.

The information provided describes the Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series. Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood pressure measurement devices are typically defined by international standards like ISO 81060-2. The document explicitly references compliance with IEC 81060-2:2009 (and
the new device uses IEC 81060-2:2013). While the document does not list the specific numerical acceptance criteria from this standard, it states that the device was tested in accordance with it and shows the reported performance for key metrics.

Note: The document states compliance with ISO 81060-2. The numerical acceptance criteria for mean difference and standard deviation are standard requirements within ISO 81060-2 for evaluating automated sphygmomanometers. While not explicitly listed with these specifics in the document, the stated "± 3 mmHg" for blood pressure accuracy implies compliance with these underlying statistical criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: One hundred patients (49 males and 51 females).
• Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective as patients were "invited for the study" and measurements were taken during the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: The document does not explicitly state the number of experts. However, it indicates that "Standard auscultation method was used as the reference blood pressure monitor," which implies measurement by trained human observers (likely medical professionals) using a stethoscope and sphygmomanometer.
• Qualifications of Experts: Not specified. However, for a clinical accuracy study using auscultation as the reference, the operators are typically trained medical personnel (e.g., physicians, nurses, or trained technicians) who are proficient in the auscultatory method.

4. Adjudication Method for the Test Set

• The document implies that the auscultation method serves as the ground truth comparator. It states, "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2." This suggests a direct comparison method rather than an adjudication process between multiple automated device readings or between the device and multiple human observers. There is no mention of 2+1, 3+1, or other adjudication methods.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the accuracy of the device against a gold standard (auscultation), not on how human readers might improve with or without AI assistance, as AI is not a component of this blood pressure monitor. The device is a standalone measurement system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone performance study was done. The clinical test evaluated the Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series as a standalone device, measuring its accuracy against the reference auscultation method without human intervention in the device's measurement process.

7. Type of Ground Truth Used

• The ground truth used was established by the standard auscultation method. This is considered the clinical gold standard for non-invasive blood pressure measurement.

8. Sample Size for the Training Set

• There is no mention of a training set in the provided document. This device is a traditional medical device (blood pressure monitor) that operates based on a pre-programmed algorithm (oscillometric methodology) rather than a machine learning or AI algorithm that requires a "training set."

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

• As there is no mention of a training set, the question is not applicable.

Ask a specific question about this device

This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.

Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.

Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and the study proving compliance.

Disclaimer: This document is a 510(k) summary for a blood pressure monitor. It focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive clinical trial report. Therefore, some of your requested information, particularly regarding advanced aspects like MRMC studies, may not be explicitly detailed or even applicable to this type of device submission.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the blood pressure monitor are primarily based on the accuracy standards outlined in ISO 81060-2:2013 and the inherent accuracy specifications of the device itself.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a Clinical Test conducted in accordance with ISO 81060-2:2013.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: One hundred (100) patients (54 males and 46 females).
• Data Provenance: Not explicitly stated (e.g., country of origin). The study seems to be prospective as it involved inviting patients for the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth was established using the Standard Auscultation method. The document does not specify the number of expert clinicians (e.g., physicians, nurses) who performed the auscultation measurements. It also does not provide their specific qualifications or years of experience. It simply refers to the "Standard Auscultation method" as the reference.

4. Adjudication Method for the Test Set

The document states: "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013." This suggests a direct comparison method rather than a separate adjudication process. No specific adjudication method like 2+1 or 3+1 for resolving discrepancies is mentioned, likely because the reference standard (auscultation) is considered the definitive ground truth for each measurement.

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 done. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role in assessing diagnostic accuracy. For a blood pressure monitor, the performance is assessed against a physical reference measurement (auscultation), not typically against multiple human readers interpreting data.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the described clinical test essentially represents a standalone performance evaluation of the algorithm built into the device. The device takes readings automatically and displays them, and these readings are directly compared to the auscultation reference. There is no human intervention in "interpreting" the device's output to make a diagnosis; the device itself provides the measurement.

7. The Type of Ground Truth Used

The type of ground truth used was expert reference standard (Standard Auscultation method). For blood pressure measurement devices, direct auscultation by a trained professional is the established gold standard for determining actual blood pressure values in a clinical setting.

8. The Sample Size for the Training Set

The document does not specify a separate training set sample size. For medical devices like this blood pressure monitor, particularly those using oscillometric methodology, the core internal algorithms are often developed and validated through extensive engineering, mathematical modeling, and internal testing during the design phase, rather than a "training set" in the machine learning sense. The clinical test described is a validation or test set activity.

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

As no separate training set is explicitly mentioned or detailed in the document, information on how its ground truth was established is not provided. If an internal "training" or development process involved ground truth measurements, these details are not part of this 510(k) summary, which focuses on the final validation study against the predicate device and relevant standards.

Ask a specific question about this device