(104 days)
Digital Automatic Blood Pressure Monitor BPM20 Scrics is for use by medical professional or home user. The BPM20 Series is intended to measure the systolic blood pressure, and pulse rate of an adult individual by using a non-invasive technique, in which an inflatable culf is wrapped around the upper arm of an individual. The inflaable cuff circumference is limited to 17cm - 44cm via 3 diffs. The 3 different cuff sizes are 17 - 22cm, 22 - 32cm and 32 - 44cm. For Bluetooth capable the measurement result can be transmitted to pre-approved mobile devices.
Digital Automatic Blood Pressure Monitor BPM20 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. Certain models of Digital Automatic Blood Pressure Monitor BPM20 Series equipment with Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile platform through Bluetooth. User can manage the measurement record by using the mobile application.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on your provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (BPM20 Series) |
|---|---|---|
| Blood Pressure Measurement Accuracy | ± 3 mmHg | ± 3 mmHg or 2% of reading |
| Pulse Rate Measurement Accuracy | ± 4 % of the reading | ± 5 % of the reading |
| Resolution of Measurement | 1 mmHg | 1 mmHg |
| Operation Temperature | +5 to +40 °C | +5 to +40 °C |
| Operation Humidity | 15-93% R.H. max | 15-93% R.H. max |
| Storage Temperature | -25 to 70 °C | -25 to 70 °C |
| Storage Humidity | Up to 95% R.H. max | Up to 95% R.H. max |
| Operation, Storage and Transportation Atmospheric Pressure | 700hPa - 1060hPa | 700hPa-1060hPa |
Note: The reported device performance for "Blood Pressure Measurement Accuracy" and "Pulse Rate Measurement Accuracy" are stated as "Equivalent" and "Similar" respectively, implying they meet or are comparable to the predicate device's criteria. The other metrics are stated as "Identical."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 100 patients (52 males and 48 females).
- Data Provenance: Not explicitly stated, but the study was conducted to comply with ISO 81060-2:2009, which is an international standard for non-invasive sphygmomanometers. This suggests the data was collected clinically, likely in a controlled environment. The country of origin is not mentioned. The study is prospective for the purpose of validating this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document mentions that "Standard auscultation method was used as the reference blood pressure monitor," but it does not specify the number of experts who performed the auscultation or their specific qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set
The document states that "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2009." This implies a direct comparison method against the auscultation standard. An explicit adjudication method like "2+1" or "3+1" is not mentioned.
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
There is no MRMC comparative effectiveness study mentioned. The device is a self-measuring blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone clinical test was performed. The device's performance was compared directly against the standard auscultation method, without human interpretation of the device's readings for adjustment or decision-making. The device, by its nature, is a standalone measurement system.
7. The Type of Ground Truth Used
The ground truth for the clinical test was established using the standard auscultation method.
8. The Sample Size for the Training Set
The document does not mention a training set or any machine learning algorithms that would require one. The device uses an oscillometric methodology, which is a traditional method for blood pressure measurement, not typically involving a "training set" in the context of AI.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned, this information is not applicable.
§ 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).