(101 days)
The UA-767PBT is designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate. At the end of each measurement, the results will be stored in the UA-767PBT memory. UA-767PBT through its Bluetooth wireless communication port can also transfer the measurements stored in memory to other electronic devices, such as an Access Point, PC, a modem, or a printer. UA-767PBT uses the oscillometric method to conduct the measurement. It is not designed for ambulatory use. The arm circumference range shall be between 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).
The A&D Medical UA-767PBT digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
UA-767PBT uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by an electrical air pump. The systolic and diastolic blood pressures arc determined by oscillometric method. The deflation rate is controlled by a presct mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff by pressing the blue "START" button. The measurement results arc displayed on the LCD and transmitted to a Bluetooth enabled devices, such as a PC, a PDA, a printer, or and access point. UA-767PBT measures blood pressure and pulse rate even when an irregular heartbeat occurs.
Acceptance Criteria and Study for A&D Medical UA-767PBT Digital Blood Pressure Monitor
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (AAMI SP-10 Section #) | Section Title | Reported Device Performance |
|---|---|---|
| 4.1.1 | General | Conformed |
| 4.1.2.1 | Device labeling | Conformed |
| 4.1.2.2 | Outer container | Conformed |
| 4.1.3 | Information manual | Conformed |
| 4.1.4.1 | Component replacement | Conformed |
| 4.1.4.2 | Power system labeling | Conformed |
| 4.1.4.3 | Labeling for battery-powered devices | Conformed |
| 4.2.1 | Storage conditions | Conformed |
| 4.2.2 | Operating conditions | Conformed |
| 4.2.3 | Vibration and shock | Conformed |
| 4.2.4.1 | Voltage range | Conformed |
| 4.2.4.2 | Life | Conformed |
| 4.3.1.1 | Maximum cuff pressure | Conformed |
| 4.3.1.2 | Cuff deflation | Conformed |
| 4.3.2 | Electrical safety | Conformed |
| 4.3.3 | Conductive components | Conformed |
| 4.4.1 | Pressure indicator accuracy | Conformed |
| 4.4.2 | Overall system efficacy | Conformed |
| 4.4.2.1 | Auscultatory method as the reference standard | Conformed |
| 4.4.2.2 | Intra-arterial method as the reference standard | Not applicable |
| 4.4.3 | Battery-powered devices | Conformed |
| 4.5 | Requirements for devices with manual inflation systems | Conformed |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for the test set of patients or readings. However, it indicates that the device's performance was evaluated against the NIST/AAMI SP-10 standard. This standard specifies requirements for non-invasive automated sphygmomanometers, which typically involve a certain number of subjects and measurements to demonstrate accuracy. Without further details of the specific test report, the exact sample size for the clinical validation cannot be determined from this summary.
The data provenance is not explicitly stated in terms of country of origin. The study is described as meeting the AAMI SP-10 standard, which is an American national standard. The nature of the study (retrospective or prospective) is also not specified, but AAMI SP-10 typically involves prospective clinical validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that the auscultatory method was used as the reference standard (ground truth) for evaluating the device's overall system efficacy (Section 4.4.2.1 of AAMI SP-10). The AAMI SP-10 standard generally requires trained human observers (e.g., medical professionals) to perform the auscultatory measurements simultaneously with the automated device.
However, the specific number of experts and their individual qualifications (e.g., "radiologist with 10 years of experience") are not detailed in this 510(k) summary. The standard usually mandates that these observers are blinded to the device's readings and are rigorously trained in the auscultatory method.
4. Adjudication Method for the Test Set
The document does not explicitly state an "adjudication method" in the context of expert consensus or disagreement. For the auscultatory method as a reference standard, the AAMI SP-10 standard often involves a technique where two or more trained observers simultaneously measure blood pressure using a mercury sphygmomanometer, and their readings must agree within a certain tolerance. If they disagree, a third observer might be involved, or the reading might be discarded. However, the specific "2+1, 3+1, none" adjudication detail is not provided in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, and therefore no effect size of human reader improvement with AI assistance is reported. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was conducted. The assessment of the A&D Medical UA-767PBT digital blood pressure monitor according to the NIST/AAMI SP-10 standard evaluates the device's accuracy in measuring blood pressure and pulse rate directly. This is an assessment of the algorithm and hardware performance without a human in the loop for interpretation or decision-making beyond operating the device. The device's oscillometric method is an automated algorithm.
7. The Type of Ground Truth Used
The type of ground truth used for evaluating the overall system efficacy (accuracy) was the auscultatory method (as specified in AAMI SP-10 Section 4.4.2.1). This method is considered the clinical reference standard for non-invasive blood pressure measurement and is performed by trained medical professionals using a stethoscope and a mercury sphygmomanometer.
8. The Sample Size for the Training Set
The document does not provide information regarding a "training set" or its sample size. Blood pressure monitors like this typically utilize established oscillometric algorithms that may have been developed and refined over many years using large datasets, but the 510(k) summary focuses on the validation of the specific device against recognized standards, rather than detailing the development of the underlying algorithm.
9. How the Ground Truth for the Training Set Was Established
Since information about a "training set" is not provided, the method for establishing its ground truth is also not described in this document.
§ 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).