(126 days)
Measure blood pressure (systolic and diastolic) and pulse rate.
UA-1200BLE of digital blood pressure monitor has the same design as the predicate devices with an inflatable cuff which is wrapped around the patient's upper arm. After the user starts the blood pressure measurement, the cuff is inflated automatically by an internal pump. The systolic and diastolic blood pressures are also determined by oscillometric method. 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. There is a maximum pressure safety setting at 299 mmHg. UA-1200BLE UltraConnect Digital Blood Pressure Monitor will not inflate the cuff higher than 299 mmHg. UA-1200BLE will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the OLED and transmitted via Bluetooth wireless module to the connected app. The cuff is also deflated automatically to 0 mmHg at the same time. If the monitor receives no further action from the user for 1 minute, it will automatically turn off by itself.
The provided text describes the clinical validation of the A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor, which is a non-invasive blood pressure measurement system. The study aims to demonstrate that the device meets the acceptance criteria for accuracy.
Here's an analysis of the acceptance criteria and study details based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The clinical test summary is based on AAMI/ANSI/ISO 81060-2 Second Edition 2013-05-01 standards.
| Item | Standard Requirements | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| Clinical Study Requirements | |||
| Number of Subjects | 85 or more | 85 | Pass |
| Number of Measurements | 3 times or more | 3 times | Pass |
| Observers | 2 | 2 | Pass |
| Observer Difference | +/-4 mmHg or less | +/- 4 mmHg less | Pass |
| Subject Demographics | |||
| Gender: Male | 30% or more | 69.4% (59 subjects) | Pass |
| Gender: Female | 30% or more | 30.6% (26 subjects) | Pass |
| Age | Older than 12 years: 100% | 100.0% (85 subjects) | Pass |
| Arm Circumference: 22.0-32.0 cm | 40% or more | 57.6% (49 subjects) | Pass |
| Arm Circumference: 32.1-42.0 cm | 40% or more | 42.4% (36 subjects) | Pass |
| Arm Circumference: 22.0-27.0 cm | 20% or more | 32.9% (28 subjects) | Pass |
| Arm Circumference: 37.0-42.0 cm | 20% or more | 20.0% (17 subjects) | Pass |
| BP Range Distribution | |||
| SBP 160mmHg | 5% or more | 5.9% (15 measurements) | Pass |
| SBP 100mmHg | 5% or more | 9.0% (23 measurements) | Pass |
| DBP > 85mmHg | 20% or more | 34.1% (87 measurements) | Pass |
| Measurement Result (Accuracy) | |||
| Average Difference (mean error) | +/-5mmHg or less | SBP: -2.66mmHg | |
| DBP: +0.90mmHg | Pass | ||
| Standard Deviation (Criteria 1) | 8mmHg or less | SBP: 6.90mmHg | |
| DBP: 6.63mmHg | Pass | ||
| Standard Deviation (Criteria 2) | 8mmHg or less | SBP: 5.35mmHg | |
| DBP: 6.12mmHg | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: 85 subjects.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, clinical validation studies for medical devices are typically prospective. The standard referenced, AAMI/ANSI/ISO 81060-2, outlines a methodology for prospective clinical validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: 2 observers (presumably trained clinical professionals, though specific qualifications like "radiologist with 10 years of experience" are not specified).
- Qualifications of Experts: The document states "Observer: 2" and "Observer Difference: +/-4 mmHg or less," which implies that the observers are trained and their measurements are consistent with each other within standard limits. However, detailed qualifications (e.g., years of experience, specific medical profession) are not provided in this summary. For a blood pressure monitor, these would typically be trained clinicians (e.g., nurses, physicians, or technicians) competent in auscultatory blood pressure measurement.
4. Adjudication Method for the Test Set
The document states "Observer: 2" and "Observer Difference: +/-4 mmHg or less," which indirectly suggests a comparison or consensus method involving two observers. For blood pressure measurement, the standard typically involves simultaneous auscultatory measurements by two trained observers, with their readings averaged or compared. The "Observer Difference" criteria implies that their readings must be in close agreement, which is a form of internal validation or adjudication on the ground truth measurement process. It doesn't specify a 2+1 or 3+1 structure, but rather that two observers produced the reference measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study, which typically compares human reader performance with and without AI assistance, was not performed based on the provided summary. This study is a standalone clinical validation for the device's accuracy against a recognized standard.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, a standalone performance study was conducted. The clinical test summary directly assesses the accuracy of the UA-1200BLE device (algorithm only, as it's an automated device) against a "ground truth" established by human observers according to the AAMI/ANSI/ISO 81060-2 standard. The results for "Measurement Result (Accuracy)" (Average Difference and Standard Deviation) directly refer to the device's performance.
7. Type of Ground Truth Used
The ground truth used was based on expert consensus/reference measurements. Specifically, it was established by two human observers performing reference blood pressure measurements (likely auscultatory, which is the gold standard for validating automated devices) in accordance with the AAMI/ANSI/ISO 81060-2 standard. The "Observer Difference" criterion supports this, indicating the two observers' measurements formed the reference.
8. Sample Size for the Training Set
The document does not provide information regarding the sample size for a training set. This summary focuses on the validation of the final device, not on the development or training of its internal algorithms.
9. How the Ground Truth for the Training Set Was Established
As no information about a training set is provided, there is no information on how its ground truth was established.
§ 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).