(535 days)
UM-211 blood pressure monitor is designed to measure systolic, diastolic pressure, and pulse rate of adults who are twelve (12) years and older in the clinics and hospitals. The arm size is from 16 cm (6.3 inches) to 50 cm (19.7 inches). UM-211 can measure blood pressure in auscultatory (device class DXQ) and oscillometric (device class DXN) methods. It can detect irregular heartbeats and display a symbol on its display.
UM-211 Digital Blood Pressure Monitors have the same design as the predicate devices with an inflatable cuff which is wrapped around the patient's upper arm. The blood pressure measurement starts with the inflation process by an internal pump. The systolic and diastolic blood pressures are determined by oscillometric method during the deflation process. The deflation rate is controlled by an internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released immediately. Furthermore, there is a maximum pressure safety setting at 299 mmHg. UM-211 Digital Blood Pressure Monitor will not inflate the cuff higher than 299 mmHg. UM-211 will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. For the oscillometric method, systolic and diastolic are determined by the internal algorithm. For the auscultatory method, systolic and diastolic are determined by the medical professionals. The results are shown on the LCD. The cuff is also deflated automatically to 0 mmHg at the same time. This auscultatory method is identical to the predicate device, UM-101 digital blood pressure monitor. The oscillometric method is identical to the predicate device with the capability to perform averaging function of multiple measurements (AOBP mode).
UM-211 also detects the patient daily activities and environmental conditions of ambient temperature and barometric pressure. These are non-medical features which will be only available for the medical professionals to review. These information are not displayed to the patient on the TM-2441 display. The BP waveform is another non-medical feature which can be used by the medical professional and A&D engineers to verify the accuracy of the blood pressure measurement. Basically, we can reconstruct the systolic, and pulse rate from the BP waveform. There is no other medical diagnose from the information of the BP waveform.
If the monitor receives no further action from the user for 1 minute, it will automatically turn off by itself and waiting for the next measurement timing. UM-211 has a memory capacity of 99 for the previous measurements.
The provided document describes the A&D Medical UM-211 Digital Blood Pressure Monitor, a non-invasive blood pressure measurement system.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Standard Requirement (Acceptance Criteria) | Reported Device Performance (Test Result) | Result |
|---|---|---|
| Criterion 1: Mean value ± 5 mmHg or less | Mean value: SYS = 3.05 mmHg, DIA = 2.87 mmHg | Passed |
| Criterion 1: Standard deviation 8 mmHg or less | Std Deviation: SYS = 3.59 mmHg, DIA = 3.48 mmHg | Passed |
| Criterion 2: Standard deviation SYS=6.20 mmHg or less, DIA=6.30 mmHg or less | Std Deviation: SYS = 3.50 mmHg, DIA = 3.11 mmHg | Passed |
Note: The table for "Criterion 2" in the original document appears to have values under "Standard Requirements" that are actually performance metrics (SYS=6.20, DIA=6.30 or less) rather than a specified standard requirement. I've interpreted these as another set of limits for standard deviation that the device performance should meet.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of participants) used for the clinical blood pressure measurement study. It also does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For blood pressure monitors, the "ground truth" (reference measurement) is typically established by trained observers using a mercury sphygmomanometer or another validated reference device, following specific protocols (e.g., simultaneous arm measurements). The document only states that "Clinical BP Measurement: ISO 81060-2:2013" was performed, which implies these procedures were followed.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method. For blood pressure measurement validation studies, ground truth is usually established by multiple observers independently taking measurements, with averaged or expert-adjudicated readings used as the reference. However, the exact method is not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This device is a digital blood pressure monitor, not an AI-assisted diagnostic tool for which human-in-the-loop performance is typically assessed in this manner.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was conducted. The accuracy of the UM-211 Digital Blood Pressure Monitor (an algorithm-based device for oscillometric measurement) was evaluated against established standards (ISO 81060-2:2013) to determine its ability to measure blood pressure independently.
7. The Type of Ground Truth Used
The ground truth used for the clinical blood pressure measurement was based on highly accurate reference measurements, as dictated by the ISO 81060-2:2013 standard. This standard specifies the requirements for the clinical validation of automated non-invasive sphygmomanometers, which typically involves comparing the device's readings to those obtained simultaneously by trained observers using a reference method (e.g., auscultatory method with a mercury sphygmomanometer).
8. The Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its size. For medical devices like this, the device's
internal algorithm for oscillometric measurement would have been developed and refined using extensive data, but this
document focuses on the validation of the final device, not the details of its developmental training.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" is not explicitly discussed for this specific device validation, the method for establishing its
ground truth is not provided. However, for the development of such devices, ground truth for training data would
typically be established using the same principles as the validation ground truth: comparison to highly accurate
reference measurements (e.g., auscultatory readings) performed by human experts.
§ 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).