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Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 are a series devices 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 upper arm.

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

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

Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 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 upper arm. 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 Arm Blood Pressure Monitor DB 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 arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm 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 AA 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 a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Automatic Arm Bluetooth Blood Pressure Monitor (Models DB62, DB63, DB85)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the ISO81060-2 Standard. The reported device performance refers to the results of the clinical study.

Note on Criterion 2: The document provides a table for Maximum permissible standard deviation, Sm, as a function of mean error, xn. The reported Std for Criterion 2 (2.56 mmHg for systolic and 2.10 mmHg for diastolic) would need to be compared against the values in this table based on the reported mean errors (2.5 mmHg for systolic and 1.8 mmHg for diastolic) to explicitly confirm conformance. However, the study directly states, "Through clinical research, we can convinced that the clinical device is safe and effective," implying these values met the standard.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 85 subjects.
• Data Provenance: The clinical study was conducted in a hospital. This suggests prospective data collection in a clinical setting, likely in the country of origin of the manufacturer (China), though not explicitly stated.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Two doctors.
• Qualifications of Experts: The document states "Simultaneous and blinded blood pressure determinations were performed by two doctors." Their specific qualifications (e.g., years of experience, specialization) are not detailed beyond "doctors."

4. Adjudication Method for the Test Set

• Adjudication Method: Implicitly, a simultaneous and blinded comparison against a standard mercury sphygmomanometer (reference standard) with two doctors performing the determinations. This suggests that the readings from the two doctors on the reference standard formed a consensus or averaged ground truth against which the device was compared. The document does not specify a formal adjudication process like "2+1" or "3+1" for resolving discrepancies between the two doctors, but rather implies their measurements constituted the reference.

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

• Was a MRMC study done? No, a MRMC comparative effectiveness study was not done. The study focused on the accuracy of the device against a gold standard, not on how human readers' performance improved with or without AI assistance.

6. Standalone Performance Study

• Was a standalone study done? Yes, the clinical study performed was a standalone study of the algorithm's performance. The device itself (Automatic Arm Bluetooth Blood Pressure Monitor) is the "algorithm only" in this context, as it automatically measures and displays blood pressure readings without a human-in-the-loop directly interpreting raw signals. Its performance was measured against the reference standard.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established using a standard mercury sphygmomanometer as a reference standard, with simultaneous and blinded blood pressure determinations performed by two doctors. This is a form of expert consensus/reference measurement, widely accepted for blood pressure monitor validation.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide information regarding a specific training set or its sample size. This is common for devices that use established physiological measurement principles (like the oscillometric method for blood pressure) rather than complex machine learning models that require explicit training on large datasets for regulatory submission. The "oscillometric method" itself is a well-known technique.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: As no specific training set is mentioned, the method for establishing its ground truth is not applicable/not provided in this document. The device operates based on the "oscillometric method," which is a pre-established principle rather than a continuously learning algorithm requiring a dedicated, labeled training set like many AI/ML devices.

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