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Truly Automatic Wrist Bluetooth Blood Pressure Monitor DW702, DW703 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.

The devices' features include irregular pulse rhythm detection during measurement, and will display an alert signal with the reading when irregular heartbeat is detected.

The devices' features include Bluetooth function to transmit data to an external Bluetooth device with wireless communication.

Truly Automatic Wrist Bluetooth Blood Pressure Monitor DW702, DW703 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".

The main components of the Truly Automatic Wrist Blood Pressure Monitor Dw series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to Wrist circumference approximately between 135 and 220 mm, includes the inflatable bladder and nylon shell. All models of the Wrist blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AAA alkaline batteries.

The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.

The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.

Here's the breakdown of the acceptance criteria and study information for the "Automatic Wrist Bluetooth Blood Pressure Monitor" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: 85 subjects.
• Data Provenance: The study was conducted "in the hospital," with no specific country of origin mentioned. It appears to be a prospective study given the description of subjects participating in a clinical study.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Two doctors.
• Qualifications of Experts: Not explicitly stated, only referred to as "two doctors." It is implied they are qualified to perform simultaneous and blinded blood pressure determinations using a standard mercury sphygmomanometer.

4. Adjudication Method

• The text states: "Simultaneous and blinded blood pressure determinations were performed by two doctors." This suggests a method where two independent readings were taken, but it doesn't specify if there was a formal adjudication process (e.g., 2+1, 3+1) if their readings differed. It implies an agreement or average was used, but no explicit adjudication method is detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The study focused on comparing the device's measurements against a reference standard (mercury sphygmomanometer) performed by human experts, not on comparing human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done. The entire clinical study described aims to demonstrate the accuracy of the device's algorithm in measuring blood pressure and pulse rate without human intervention in the actual measurement process (beyond applying the cuff and initiating the device). The device itself performs the measurement and provides the readings.

7. Type of Ground Truth Used

• The ground truth used was expert consensus / reference standard measurements. Specifically, the ground truth was established by "a standard mercury sphygmomanometer" with "simultaneous and blinded blood pressure determinations" performed by two doctors.

8. Sample Size for the Training Set

• The document does not provide any information regarding the sample size used for the training set. This submission is for a 510(k) premarket notification, which often focuses on clinical validation using existing technology (oscillometric method) rather than detailing the machine learning aspects of an AI algorithm from scratch.

9. How Ground Truth for the Training Set Was Established

• As the document does not provide information on a training set, it does not describe how ground truth for a training set was established. The oscillometric method is a well-established technique described as "a well-known technique in the market." The device is an "upgraded version to include the Bluetooth 4.0 Wireless function" of a previous device. The clinical study serves to validate the performance of the device against a known standard.

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