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HL858CP automatically measures human's Systolic 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 22 inches (approx.23 cm to 56 cm) and for home use.

The device can accurately measure in pregnant patients including those with known or suspected in preeclampsia condition.

HL858CP detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the user tracking their blood pressure level.

Besides, the device features a built-in "Bluetooth Data 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 monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.

HL858CP 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 22 inches (approx.23 cm to 56 cm) and for home use. The device can accurately measure blood pressure in pregnant patients including those with known or suspected in pre-eclampsia condition.

The device will display a symbol O-W- 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. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.

Besides, when Triple Check mode is turned on by user, the symbol ) will display on the LCD. Then press Start/Stop button the device will take three consecutive measurements automatically at 1 minute intervals. After measurements are completed LCD will display the average values of the three measurements.

HL858CP is equipped with Bluetooth Data Transmission function, which can electronic transfer the measured data of HL858CP to the paired Bluetooth-enabled device. The transferable measured data includes Systolic, Diastolic, and Pulse. The Bluetooth Data Transmission is without controlling or altering the functions or parameters of HL858CP and Paired Bluetooth-enabled device. In addition, the Bluetooth Data Transmission function could transfer the battery status of HL858CP to the Paired Bluetooth-enabled device without any controlling or altering on both devices.

Besides, Bluetooth Data Transmission function could provide Date/Time synchronization for HL858CP, which simply help users set Time/ Date information. It will help users prevent from entering incorrect time information.

The provided text describes the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CP, and its clinical validation, particularly regarding its ability to accurately measure blood pressure in pregnant patients, including those with pre-eclampsia. This information is gleaned from various sections of the 510(k) Summary.

Here's a breakdown of the requested information:

Device: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CP

1. Table of Acceptance Criteria and Reported Device Performance

The core clinical validation for non-invasive sphygmomanometers, including this device, is typically against the ISO 81060-2 standard. This standard sets specific criteria for accuracy.

Note: While the summary states that the criteria were fulfilled, the exact numerical performance values (mean difference and standard deviation) are not explicitly given in the provided text for either the general or pregnant populations. The summary focuses on meeting the standard.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: "90 subjects with qualified distribution."
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, for a clinical validation study for a medical device approval, especially an accuracy study like this, it is almost exclusively prospective and generally conducted in a controlled clinical environment (e.g., a hospital or clinic). The lack of country specification likely means it was conducted where the manufacturer is based or in a region with established clinical trial infrastructure that is recognized by the FDA (e.g., often US, Taiwan, Europe).

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

The document does not specify the number or qualifications of experts used to establish the ground truth. For blood pressure measurement validation according to ISO 81060-2, the ground truth is typically established by trained medical professionals (e.g., physicians or nurses) using a validated reference sphygmomanometer (e.g., mercury sphygmomanometer) following a rigorous protocol (e.g., auscultatory method with trained independent observers). The standard prescribes specific requirements for these observers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not explicitly describe an adjudication method for the test set. For ISO 81060-2 validation, the ground truth is typically captured by two independent observers (auscultatory method), and if there's a significant discrepancy, a third observer might be involved. The standard has specific requirements for the agreement between observers (e.g., differences within certain mmHg). While not explicitly stated as "adjudication," this method ensures robust ground truth.

5. 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

This device is a blood pressure monitor, not an AI-assisted diagnostic imaging device. Therefore, a multi-reader, multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device. The study described is a clinical validation of the device's measurement accuracy against a reference standard.

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

Yes, a standalone performance study was done. The entire clinical investigation described ("compliant to the standard of ISO 81060-2: Second Edition 2013-05-01") is a standalone algorithm (device) performance study. The device's measurements are directly compared to the clinically established ground truth, demonstrating the device's accuracy without requiring human interpretation or intervention in the measurement process beyond device operation.

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

The ground truth used is based on clinically established reference measurements of blood pressure, typically using the auscultatory method with a mercury sphygmomanometer (or an equivalent validated reference device) performed by trained medical professionals, as per the ISO 81060-2 standard. This is most akin to an expert consensus method from trained individuals applying a gold standard technique.

8. The sample size for the training set

The document does not specify a training set sample size. This is common for traditional medical devices like blood pressure monitors, which are validated against standards like ISO 81060-2 based on their mechanical and algorithmic adherence to established measurement principles, rather than being "trained" like machine learning models. The 90 subjects mentioned are for the clinical validation/test set.

9. How the ground truth for the training set was established

As there is no "training set" in the context of machine learning for this device, a specific method for establishing ground truth for a training set is not applicable/not detailed. The device's internal algorithms for oscillometric blood pressure measurement are developed based on established physiological principles and engineering, not typically via a data-driven training process in the way AI models are.

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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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