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This device uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being's arm. All values can be read out in the LCD panel. Measurement position is at human being's upper arm. The intended user of this over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use. HL858DM features BP Category Indicator that will show the information with the readings on the user tracking their blood pressure level. HL858DM is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected. Besides, the device features a built-in "Bluetooth Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure montor by means of DailyChek® application software with the paired Bluetooth-enabled device.

HL858DM automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use. The device has the Risk Category Indicator, Irregular Heartbeat Detector, Bluetooth data transmission functions. When the symbol Advanced IHB appears on screen indicates the specific heartbeat irregularity was detected during measurement. Additionally, after measurement, the BP Category Indicator feature will show the information with the readings on the screen for the user tracking their blood pressure level. Besides, HL858DM featured with an IHB feature can identify the specific irregular heartbeats that may cause deviated blood pressure reading.

The device in question is the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM.

Here's an analysis of its acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the sample size used for the clinical validation. It only mentions that the device is compliant with ISO 81060-2:2018, which is the "Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type."
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that "All the relevant activities were performed by designate individual(s)."

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

• The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical validation. ISO 81060-2 typically requires comparisons to expert observer measurements, but the specifics are not detailed here.

4. Adjudication Method for the Test Set:

• The document does not specify the adjudication method used for the test set.

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

• No MRMC comparative effectiveness study was done. This device is a blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve multiple human readers. The clinical validation focuses on the accuracy of the device's measurements against a reference method.

6. Standalone Performance Study:

• Yes, a standalone study was performed. The clinical validation was focused on the device's ability to accurately measure blood pressure and heart rate as a standalone system, in compliance with ISO 81060-2:2018. The document states, "The subject device HL858DM is compliant to the standard of ISO 81060-2:2018 Noninvasive sphygmomanometers- Part 2: Clinical validation of automated measurement type." This standard specifically outlines the requirements for clinical validation of automated blood pressure devices.

7. Type of Ground Truth Used:

• Based on compliance with ISO 81060-2:2018, the ground truth for blood pressure measurement is established through simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer or another validated reference oscillometric device. The standard dictates a rigorous protocol for comparison. The document does not explicitly detail the exact ground truth method used beyond referencing the standard.

8. Sample Size for the Training Set:

• This device is a hardware blood pressure monitor and does not explicitly use a "training set" in the context of machine learning algorithms for its core measurement function. Its measurement principle is based on oscillometry. The "training" in this context would refer to the calibration and internal algorithm development by the manufacturer, which is not detailed in the provided document.

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

• As noted above, this device does not have a "training set" in the machine learning sense. The underlying algorithms for oscillometric blood pressure measurement are developed and validated through engineering and physiological principles, and then verified through clinical trials like the one referenced.

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