(100 days)
Digital Automatic Blood Pressure Monitor BPM18 Series is for use by medical professional or home user. The BPM18 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate 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 BPM18 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 provided documentation describes the Digital Automatic Blood Pressure Monitor BPM18 Series. This device is a non-invasive blood pressure measurement system intended for use by medical professionals or at home to measure systolic and diastolic blood pressure and pulse rate.
Here's an analysis of the acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate) | Reported Device Performance (BPM18 Series) |
|---|---|
| Blood Pressure Measurement Accuracy: ± 3 mmHg or 2% of reading | Meets Blood Pressure Measurement Accuracy: Confirmed via clinical test in accordance with ISO 81060-2:2009. |
| Pulse Rate Measurement Accuracy: ± 5 % of the reading | Meets Pulse Rate Measurement Accuracy: Confirmed via clinical test in accordance with ISO 81060-2:2009. |
| Blood Pressure Measurement Range: Cuff Pressure: 0 - 300 mmHg, | Identical: Cuff Pressure: 0 - 300 mmHg, |
| Systolic Pressure: 50 - 250 mmHg, Diastolic Pressure: 30 - 200 mmHg | Systolic Pressure: 50 - 250 mmHg, Diastolic Pressure: 30 - 200 mmHg |
| Pulse Rate Measurement Range: 30 - 180 beats/min | Identical: 30 - 180 beats/min |
| Operating Condition: Temperature: 10 - 40 °C, Humidity: 30 - 85 % R.H. max, Atmospheric Pressure: 700 - 1060 kPa | Equivalent, improved specification: Temperature: 10 - 40 °C, Humidity: 15 - 85 % R.H. max, Atmospheric Pressure: 700 - 1060 kPa |
| Applicable Standards (key ones mentioned): EN 1060-1, EN 1060-3, IEC 60601-1, IEC 60601-1-2, ISO 81060-2 | Complies with updated versions of relevant standards including IEC 60601-1:2012 and IEC 81060-2:2009. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 100 patients (49 males and 51 females) were enrolled in the clinical study.
- Data Provenance: Not explicitly stated, but the submission is from "GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED" in "People's Republic of China", suggesting the study likely took place in that region. The study is prospective in nature as patients were "invited for the study" with blood pressure measurements taken specifically for this evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- The ground truth was established using the "Standard auscultation method." This method is typically performed by trained medical professionals (e.g., a physician or nurse) using a stethoscope and sphygmomanometer.
- The document does not specify the number of experts, nor their specific qualifications (e.g., number of 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 for individual measurements rather than an adjudication process between multiple readers for ground truth generation. The auscultation method likely served as the single reference (ground truth) against which the device's readings were compared. There is no mention of a 2+1 or 3+1 adjudication method.
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 explicitly mentioned or conducted. The study focused on the accuracy of the device against a reference standard (auscultation) rather than comparing human reader performance with and without AI assistance. The device is a standalone blood pressure monitor without AI-assisted interpretation capabilities mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Yes, a standalone performance study was done. The "Clinical Test Summary" describes the device's performance against the "standard auscultation method" without human intervention for the device's measurement and interpretation of blood pressure. The device itself uses an oscillometric methodology to produce digital readings.
7. The Type of Ground Truth Used
- The ground truth used was expert measurement/reference standard, specifically the "Standard auscultation method."
8. The Sample Size for the Training Set
- The document does not specify a training set sample size. This is typical for medical devices like blood pressure monitors that use established physical principles (oscillometric method) rather than complex machine learning algorithms that require extensive training data. The device's design and parameters would be developed and refined through engineering and calibration, not typically by training on a large dataset in the way a deep learning model would.
9. How the Ground Truth for the Training Set Was Established
- Since there's no mention of a training set in the context of machine learning, there's no ground truth established for a training set. The device relies on its internal algorithms and calibration based on known physiological principles of oscillometric blood pressure measurement.
§ 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).