(13 days)
The Arm Type Digital Blood Pressure Monitor is a table top AC/DC powered operated arm type blood pressure monitor which is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the upper arm and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) blood pressure: 20 to 280 mmHg (2) pulse : 40 to 200 pulses/minutes.
The Ya Horng Arm Type Digital Blood Pressure Monitors, Types BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB , BP-600J, BP-600RJ, BP-600UJ, BP-600BJ, BP-600RBJ, BP-600UBJ are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by oscillometric method in which an inflatable cuff is wrapped around the upper arm. It uses an electronic capacitive pressure sensor to convert tiny alternations in cuff pressure to electrical signals. It analyze those signals to define the systolic and diastolic blood pressure and calculating pulse rate. Some models are with RS232 or USB ports to connect to the personal computer to store the measured data.
The Ya Horng Arm Type Digital Blood Pressure Monitor (Models BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J, BP-600RJ, BP-600UJ, BP-600BJ, BP-600RBJ, BP-600UBJ) was evaluated for its accuracy in measuring blood pressure and pulse rate.
1. Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against the ANSI/AAMI SP-10-2002 standard for non-invasive blood pressure measurement systems. While specific numerical acceptance criteria from the standard are not explicitly stated in the provided text, the summary indicates that the "clinical effectiveness conforms to the standard." This implies that the device met the accuracy and reliability requirements outlined in ANSI/AAMI SP-10-2002.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Effectiveness | Conforms to ANSI/AAMI SP-10-2002 standard |
2. Sample Size and Data Provenance
The provided text does not specify the sample size used for the clinical test set nor the data provenance (e.g., country of origin, retrospective or prospective). It only states "Discussion of clinical tests performed: The clinical effectiveness conforms to the standard of ANSI/AAMI SP-10-2002."
3. Number and Qualifications of Experts for Ground Truth
The provided text does not specify the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication Method
The provided text does not specify any adjudication method used for the clinical tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is focused on the device's standalone performance in accordance with a recognized standard, not on comparing human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was performed. The "Discussion of clinical tests performed" section explicitly states that "The clinical effectiveness conforms to the standard of ANSI/AAMI SP-10-2002." This indicates that the device, operating as an algorithm-only system (without human-in-the-loop performance influencing its core measurement), underwent clinical testing against this standard. The device itself is described as using an "electronic capacitive pressure sensor to convert tiny alternations in cuff pressure to electrical signals. It analyze those signals to define the systolic and diastolic blood pressure and calculating pulse rate." This is the core algorithm being tested in a standalone capacity.
7. Type of Ground Truth Used
The type of ground truth used is implied to be clinical reference measurements that conform to the ANSI/AAMI SP-10-2002 standard. This typically involves simultaneous measurements taken by trained healthcare professionals using a validated reference method (e.g., mercury sphygmomanometry) against which the automated device's readings are compared.
8. Sample Size for Training Set
The provided text does not mention a training set or its sample size. The device relies on an "oscillometric method within the software algorithm," which is a known technique for blood pressure measurement rather than a new machine learning algorithm that typically requires explicit training data.
9. How Ground Truth for Training Set Was Established
Since no training set is mentioned for a machine learning model, the concept of establishing ground truth for a training set is not applicable here. The device's algorithm likely uses established 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).