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HL858DK 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 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.

HL858DK features BP Category Indicator that will show the information with the readings on the screen for the user tracking their blood pressure level.

HL858DK 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.

HL858DK 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.

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.

HL858DK 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 deviation, the 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.

The device referenced is the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DK.

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

1. Table of Acceptance Criteria and Reported Device Performance

The primary performance criterion for non-invasive blood pressure monitors, as per ISO 81060-2, relates to the accuracy of blood pressure and pulse measurements.

2. Sample Sizes and Data Provenance

• Test Set (Blood Pressure Accuracy):

  • Sample Size: 85 subjects.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the description of a "clinical investigation" strongly suggests a prospective study specifically designed to validate the device's accuracy.

• Test Set (Advanced Irregular Heartbeat Detection):

  • Sample Size: 189 subjects.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Similar to the BP accuracy study, this sounds like a prospective clinical test.

3. Number of Experts and Qualifications (for Ground Truth)

The document does not provide details about the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). For blood pressure monitors, ground truth for clinical validation (e.g., according to ISO 81060-2) typically involves simultaneous auscultatory measurements performed by trained clinicians (often two or more) using a mercury sphygmomanometer or validated reference device. For IHB detection, the ground truth would typically be established by a reference ECG/EKG or similar cardiological assessment.

4. Adjudication Method for Test Set

The document does not explicitly describe the adjudication method used for establishing the ground truth (e.g., 2+1, 3+1). For ISO 81060-2 studies, simultaneous measurements by two independent observers are standard, with a third if discrepancies occur, but this specific detail is not provided.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted, nor is there any mention of an effect size for human readers improving with AI vs. without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance

Yes, a standalone performance study was clearly done. The clinical investigation directly assessed the performance of the device itself (HL858DK) against established standards for blood pressure accuracy (ISO 81060-2) and the performance of its Advanced Irregular Heartbeat Detection feature. There is no human-in-the-loop component described for these performance evaluations.

7. Type of Ground Truth Used

• Blood Pressure Accuracy: The explicit reference to "ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type" implies that the ground truth was established through simultaneous reference measurements (e.g., auscultatory measurements from trained observers using a calibrated reference device) on the same subjects. This is the standard method for validating automated blood pressure devices.
• Irregular Heartbeat Detection: While not explicitly stated, the ground truth for "Advanced IHB detection" performance (sensitivity and specificity) would typically be established by a reference electrocardiogram (ECG) or similar cardiological gold standard to confirm the presence or absence of irregular heartbeats.

8. Sample Size for Training Set

The document does not provide any information about a "training set" or its sample size. This suggests that the device's algorithms (e.g., for oscillometric measurement or IHB detection) were likely developed and validated internally by the manufacturer, and the described studies are the clinical validation/test sets for regulatory submission, not part of an AI model's training phase. Devices like this typically use established, non-AI algorithms.

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

As no training set is mentioned for an AI model, this question is not applicable based on the provided document. The device uses an oscillometric method (a well-established principle) and likely rule-based or signal processing algorithms for IHB detection, rather than a machine learning model requiring a distinct training pipeline and associated ground truth establishment.

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