(451 days)
UM-212BLE blood pressure monitor is designed to measure systolic, diastolic pressure, and pulse rate of children and adults who are three (3) years and older in clinics and hospitals. The arm size is from 12 cm (4.7 inches) to 50 cm (19.7 inches). It can detect irregular heartbeats and display a symbol on its display and transmit the measurement by Bluetooth to other devices, such as PC, mobile phones, and gateways.
UM-212BLE 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. There is a maximum pressure safety setting at 299 mmHg. UM-212BLE Blood Pressure Monitor will not inflate the cuff higher than 299 mmHg. The device will display an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressure reading with pulse rate are shown on the LCD. The values can also be transmitted by Bluetooth communication. The cuff is automatically deflated to 0 mmHg at the same time that the measurement is being displayed. If the monitor receives no further action from the user for 1 minute, it will automatically turn off.
Here's a breakdown of the acceptance criteria and study details for the A&D Medical UM-212BLE Blood Pressure Monitor, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria were based on the ISO 81060-2:2013 standard for non-invasive sphygmomanometers. The study evaluated the device's accuracy in measuring systolic and diastolic blood pressure.
| Standard Requirements (Acceptance Criteria) | Reported Device Performance (Adults) | Result |
|---|---|---|
| Criterion 1 (Adults): | ||
| Max Mean error of measurement: ± 5.0 mmHg | Mean value: SYS = +3.05 mmHg, DIA = +2.87 mmHg | Pass |
| Standard deviation (S.D.): 8.0 mmHg or less | Std deviation: SYS = 3.59 mmHg, DIA = 3.48 mmHg | Pass |
| Criterion 2 (Adults) - based on ISO 81060-2:2013 Table 1: | ||
| Permissible Standard Deviation: SYS=6.20 mmHg, DIA=6.30 mmHg | Std deviation: SYS = 3.50 mmHg, DIA = 3.11 mmHg | Pass |
| Criterion 1 (Children): | ||
| Max Mean error of measurement: ± 5.0 mmHg | Mean value: SYS = +3.74 mmHg, DIA = +2.88 mmHg | Pass |
| Standard deviation (S.D.): 8.0 mmHg or less | Std deviation: SYS = 1.15 mmHg, DIA = 1.55 mmHg | Pass |
| Criterion 2 (Children) - based on ISO 81060-2:2013 Table 1: | ||
| Max Permissible Standard Deviation: SYS=5.77 mmHg, DIA=6.30 mmHg | Std deviation: SYS = 1.04 mmHg, DIA = 1.37 mmHg | Pass |
The device passed all specified accuracy requirements for both adult and child measurements.
2. Sample Sizes and Data Provenance
The document does not explicitly state the exact sample sizes (number of subjects) used for the clinical investigation of automated measurement type (ISO 81060-2:2013). However, the standard itself requires a minimum of 85 subjects for the primary validation.
Regarding data provenance, the document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states that "A&D Medical conducted design verification and design validation activities."
3. Number of Experts and Qualifications for Ground Truth
For blood pressure measurement devices, human experts (trained observers) are typically used to establish ground truth through a reference measurement method (e.g., auscultation with a mercury sphygmomanometer). The document does not specify the number or qualifications of experts involved in the clinical investigation. However, for a study following ISO 81060-2, trained observers are a prerequisite, and their training and adherence to the standard's methodology are essential for the validity of the ground truth.
4. Adjudication Method for the Test Set
The document does not describe a specific "adjudication method" in the context of expert consensus, as this device measures a physiological parameter rather than interpreting complex medical images. The ground truth for blood pressure is established through simultaneous or closely sequential measurements by a qualified reference method, usually involving multiple valid measurements per subject. The ISO 81060-2 standard outlines the specific protocol for parallel measurements with an observer.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not applicable here as the device is an automated blood pressure monitor measuring a physiological parameter, not an AI interpreting medical images requiring human reader comparison. Therefore, there's no comparison of human readers improving with AI vs. without AI assistance.
6. Standalone (Algorithm Only) Performance
The entire clinical investigation (ISO 81060-2:2013) is a standalone performance test of the algorithm (device) against a reference standard. The results provided in the table are the standalone performance of the blood pressure monitor.
7. Type of Ground Truth Used
The type of ground truth used is based on reference blood pressure measurements obtained through a validated method (typically auscultation with a mercury sphygmomanometer) by trained observers, as stipulated by ISO 81060-2:2013. This is a direct physiological measurement, not expert consensus on an interpretation, pathology, or outcomes data in the typical sense of AI diagnostics.
8. Sample Size for the Training Set
The document does not provide information on a "training set" or "test set" in the context of machine learning model development. For a device like a blood pressure monitor, the "design verification and design validation activities" are traditionally engineering and clinical studies to confirm the device's adherence to performance standards, rather than training an AI model.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" and its associated ground truth establishment is not directly applicable to this type of device validation in the context of the provided 510(k) summary. The "ground truth" for the device's performance validation is the accurate simultaneous or near-simultaneous measurement of blood pressure by a validated reference method during clinical testing, as per ISO 81060-2.
§ 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).