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HL858GA 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 one LCD panel. The device is designed and recommended for use by people over the age of 18 with arm circumference ranging from approx.9 inches to 17 inches (23 cm to 43 cm) and for home use.

When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. And this device can let the memory data be transferred to the connected personal computer (PC) via USB cable.

Besides, Risk Category Indicator (Six Levels) feature will judge blood pressure results into six levels based on WHO (World Health Organization) classification with corresponding bar segment on the edge of screen.

HL858GA 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 one LCD panel. The device is designed and recommended for use by people over the age of 18 with arm circumference ranging from approx.9 inches to 17 inches (23 cm to 43 cm) and for home use.

The device is equipped with Irregular Heartbeat Detector function which display a symbol of or or ma, to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Besides, user can save and manage the measurement data by transferring the measured readings of blood pressure to the connected personal computer (PC) via USB cable. Additionally, the Risk Category Indicator (Six Levels) feature will classify the blood pressure results with WHO (World Health Organization) Classifications, which are Sever Hypertension, Moderate Hypertension, Mild Hypertension, High Normal, Normal, and Optimal. The Corresponding LCD segment will be turned on along with the systolic, diastolic, and heart rate information.

The provided text describes the 510(k) summary for the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858GA. Here's an analysis of the acceptance criteria and the study information:

Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Same as left" in the "Subject device HL858GA" column for these performance criteria, indicating that the new device aims to meet the same specifications as its predicate device. The clinical study confirmed that these criteria were met.

Study Details

1. Sample size used for the test set and the data provenance:

   • The document states that the device is "compliant to the ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002 / / A 1:2003/(R )2008 & ANSI/AAMI SP10:2002/ A2:2006/(R)2008 Manual, electronic or automated sphygmomanometers."
   • These standards typically specify the number of subjects required for validation (e.g., 85 subjects with specific age and blood pressure distributions as per AAMI SP10). However, the specific sample size used in this particular study is not explicitly stated in the provided text.
   • Data provenance: Not explicitly stated. These standards generally involve prospective clinical studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not explicitly stated. For blood pressure monitors, ground truth is typically established by trained human observers using a mercury sphygmomanometer or a validated auscultatory reference device, following the AAMI SP10 protocol. The standard would define the qualifications for these observers, generally requiring specific training and certification in auscultatory blood pressure measurement.

3. Adjudication method for the test set:

   • Not explicitly stated. AAMI SP10, which the device complies with, typically involves multiple observers (often two) taking simultaneous measurements, with their readings compared against each other and against the automated device's readings. Discrepancies may be resolved by a third observer or specific statistical methods.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance evaluation was done. The entire premise of automated blood pressure monitors is to provide readings without human-in-the-loop interpretation beyond operating the device. The clinical study assessed the device's accuracy against reference measurements, which is a standalone performance evaluation for such a device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For blood pressure monitors, the ground truth is established through simultaneous measurements by trained human observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer). This aligns with the methodologies prescribed in the ANSI/AAMI SP10 standard.

7. The sample size for the training set:

   • Not applicable / Not stated. Automated blood pressure monitors like this one are based on oscillometric algorithms, which are typically developed using engineering principles and physiological models, rather than machine learning "training sets" in the modern sense of deep learning. While initial algorithm development involves data, it's not typically referred to as a "training set" in the context of these devices. The approval process focuses on validation of the final algorithm's performance.

8. How the ground truth for the training set was established:

   • Not applicable / Not stated. As mentioned above, the concept of a "training set" with established ground truth, as used in AI/ML, doesn't directly apply here in the same way. The oscillometric method's principles are established, and the manufacturer fine-tunes the algorithm to accurately transform cuff pressure oscillations into blood pressure values. Ground truth for validation (testing) would be established by trained observers as per AAMI SP10.

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