(36 days)
The A&D LifeSource UB-511 & UB-512 digital blood pressure monitors are intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
Measure blood pressure (systolic and diastolic) and pulse rate.
The A&D LifeSource UB-511 & UB-512 digital blood pressure monitors are intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. UB-511 & UB-512 use an inflated cuff which is wrapped around the wrist. The cuff is inflated automatically by the air pump. The systolic and diastolic blood pressures are determined by oscillometric method while the cuff is inflated. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for one minute. The blood pressure results are compared with WHO (World Health Organization) BP classifications, which are Sever Hypertension, Moderate Hypertension, Mild Hypertension, High Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. UB-511 & UB-512 measure blood pressure and pulse rate even when an irregular heartbeat occurs. After one minute without operation, UB-511 & UB-512 turns off automatically.
Here's a summary of the acceptance criteria and study information for the A&D LifeSource UB-511 & UB-512 Digital Blood Pressure Monitors, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Standard / Section) | Reported Device Performance |
|---|---|
| NIST/AAMI SP-10 Section 4.1.1 (General) | Conformed |
| NIST/AAMI SP-10 Section 4.1.2.1 (Device labeling) | Conformed |
| NIST/AAMI SP-10 Section 4.1.2.2 (Outer container) | Conformed |
| NIST/AAMI SP-10 Section 4.1.3 (Information manual) | Conformed |
| NIST/AAMI SP-10 Section 4.1.4.1 (Component replacement) | Conformed |
| NIST/AAMI SP-10 Section 4.1.4.2 (Power system labeling) | Conformed |
| NIST/AAMI SP-10 Section 4.1.4.3 (Labeling for battery-powered devices) | Conformed |
| NIST/AAMI SP-10 Section 4.2.1 (Storage conditions) | Conformed |
| NIST/AAMI SP-10 Section 4.2.2 (Operating conditions) | Conformed |
| NIST/AAMI SP-10 Section 4.2.3 (Vibration and shock) | Conformed |
| NIST/AAMI SP-10 Section 4.2.4.1 (Voltage range) | Conformed |
| NIST/AAMI SP-10 Section 4.2.4.2 (Life) | Conformed |
| NIST/AAMI SP-10 Section 4.3.1.1 (Maximum cuff pressure) | Conformed |
| NIST/AAMI SP-10 Section 4.3.1.2 (Cuff deflation) | Conformed |
| NIST/AAMI SP-10 Section 4.3.2 (Electrical safety) | Conformed |
| NIST/AAMI SP-10 Section 4.3.3 (Conductive components) | Conformed |
| NIST/AAMI SP-10 Section 4.4.1 (Pressure indicator accuracy) | Conformed |
| NIST/AAMI SP-10 Section 4.4.2 (Overall system efficacy) | Conformed |
| NIST/AAMI SP-10 Section 4.4.2.1 (Auscultatory method as the reference standard) | Conformed |
| NIST/AAMI SP-10 Section 4.4.2.2 (Intra-arterial method as the reference standard) | Not applicable |
| NIST/AAMI SP-10 Section 4.4.3 (Battery-powered devices) | Conformed |
| NIST/AAMI SP-10 Section 4.5 (Requirements for devices with manual inflation systems) | Conformed |
| FDA guidance "Non-invasive Blood Pressure (NIBP) Monitor Guidance" | Conformed |
Study Details
-
Sample size used for the test set and the data provenance:
The document states, "UB-511 & UB-512 are not clinically tested." This implies that there was no separate test set used for clinical validation of blood pressure accuracy from human subjects. The device's performance against the AAMI SP-10 and FDA guidance was reported as "Conformed" for various technical and safety aspects, which would involve testing the device itself, not necessarily on a human subject test set. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set on human subjects was conducted for this specific device. The device's equivalence was based on its identical software codes and pressure detection hardware to predicate devices. -
Adjudication method for the test set:
Not applicable, as no clinical test set on human subjects was conducted for this specific device. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC study was not done. The device was "not clinically tested" and its substantial equivalence was based on technological characteristics and conformity to standards rather than comparative clinical effectiveness with human readers or devices. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document indicates that the UB-511 & UB-512 "use the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate." This implies that the algorithm's performance (specifically the oscillometric method) was relied upon based on the predicate devices' established performance. While not explicitly stated as a standalone study for this specific device, the technical conformity relies on the standalone performance of the underlying technology shared with the predicates. -
The type of ground truth used:
For the technical tests (e.g., pressure indicator accuracy, overall system efficacy), the ground truth would have been established by calibrated instruments and reference methods as dictated by the AAMI SP-10 standard (e.g., auscultatory method as a reference standard for overall system efficacy). For the general performance of the blood pressure measurement technology, the established performance of the predicate devices implicitly serves as the ground truth. -
The sample size for the training set:
Not applicable. As the device was not clinically tested, and its equivalence relies on predicate devices, there is no mention of a training set for an algorithm developed specifically for this device. The shared software codes and hardware indicate that any "training" (if applicable to the algorithm's development) would have occurred for the predicate devices. -
How the ground truth for the training set was established:
Not applicable, as no training set for a new algorithm was utilized for this device.
§ 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).