(92 days)
The UA-767BT 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-767BT memory. UA-767BT 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. The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. UA-767BT 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-767BT digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. UA-767BT 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 are determined by oscillometric method. The deflation rate is controlled by a preset 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 are displayed on the LCD and transmitted to a Bluetooth enabled devices, such as a PC, a PDA, a printer, or and access point.
Here's a breakdown of the acceptance criteria and study information for the A&D Medical UA-767BT Digital Blood Pressure Monitor, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (SP-10 Section) | Description | Reported Device Performance |
|---|---|---|
| 4.1.1 | General requirements | Conformed |
| 4.1.2.1 | Device labeling | Conformed |
| 4.1.2.2 | Outer container labeling | Conformed |
| 4.1.3 | Information manual | Conformed |
| 4.1.4.1 | Component replacement information | 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 resistance | Conformed |
| 4.2.4.1 | Voltage range | Conformed |
| 4.2.4.2 | Life (durability) | Conformed |
| 4.3.1.1 | Maximum cuff pressure | Conformed |
| 4.3.1.2 | Cuff deflation rate | Conformed |
| 4.3.2 | Electrical safety | Conformed |
| 4.3.3 | Conductive components safety | Conformed |
| 4.4.1 | Pressure indicator accuracy | Conformed |
| 4.4.2 | Overall system efficacy (measurement accuracy) | Conformed |
| 4.4.2.1 | Auscultatory method as the reference standard (for overall system efficacy) | Conformed |
| 4.4.2.2 | Intra-arterial method as the reference standard | Not applicable |
| 4.4.3 | Battery-powered devices requirements | Conformed |
| 4.5 | Requirements for devices with manual inflation systems | Conformed |
Note: The document explicitly states, "UA-767BT is not clinically tested." Instead, it relies on demonstrating conformance to the NIST/AAMI SP-10 standard and FDA guidance "Non-invasive Blood Pressure (NIBP) Monitor Guidance." The performance reported is "Conformed" for each section, indicating the device met the requirements outlined in the standard for non-invasive blood pressure monitors.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided document. The document refers to conformance to AAMI SP-10 tests, which typically involve a specified number of subjects and measurements, but these details are not provided here.
- Data Provenance: Not explicitly stated. The tests are described as conforming to the AAMI SP-10 standard, which implies a standardized testing methodology. However, details about the location or specifics of the test data (e.g., country of origin, retrospective/prospective) are not included.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not explicitly stated. For the "Overall system efficacy" (4.4.2) and "Auscultatory method as the reference standard" (4.4.2.1) criteria, the AAMI SP-10 standard typically requires measurements to be taken by trained observers (experts) using a reference method. However, the exact number and qualifications of these observers are not detailed in this submission.
- Qualifications of Experts: Not explicitly stated. For the auscultatory method, the experts would typically be trained clinicians (e.g., physicians, nurses) proficient in taking manual blood pressure measurements.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. In AAMI SP-10 testing, when multiple observers are used for the auscultatory reference, there are usually methods for reconciling differences in their readings (e.g., averaging, discarding outliers, or requiring consensus). However, this document does not describe the specific adjudication method used.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a standalone blood pressure monitor and does not involve AI assistance for human readers or interpretation of medical images/data in a way that would necessitate such a study. The product is a direct measurement device rather than an interpretive aid.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the device's performance was evaluated in a standalone manner. The entire testing listed in the table under "DEVICE TESTING" refers to the performance of the UA-767BT device itself, measuring its accuracy and conformance to the AAMI SP-10 standard without human intervention in the measurement process (other than operating the device as intended for a non-invasive blood pressure monitor). The key statements are: "UA-767BT is not clinically tested" and "It uses the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate." This indicates technical performance validation against a standard, not a human-in-the-loop study.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for the device's accuracy (specifically for blood pressure measurements) was established through the auscultatory method as the reference standard (SP-10 Section 4.4.2.1). This method involves trained human observers using a stethoscope and sphygmomanometer to manually determine systolic and diastolic blood pressure, which is considered the gold standard for non-invasive blood pressure measurement against which automated devices are compared.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense. Its function is based on oscillometric principles and pre-programmed algorithms, not a learning model developed from a data set. The document states it uses "identical software codes and pressure detection related hardware as the predicate devices."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set for machine learning. The device's underlying algorithms are based on established oscillometric principles and inherited from a predicate device, which would have undergone its own validation based on the auscultatory method as ground truth.
§ 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).