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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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This device automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. 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.

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.

HL858CA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. 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 will display a symbol "orman, 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: Furthermore, the 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.

Besides, When Triple Check mode is turned on by user, the symbol ( 3 mm ) 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. And this device is designed with Rest Assure function as a countdown timer to help user in relax state for 5 minutes before taking measurement.

Here's a breakdown of the acceptance criteria and study information for the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CA, based on the provided text:

Acceptance Criteria and Reported Device Performance

The device's performance is primarily evaluated against the ANSI/AAMI SP10 standard for manual, electronic, or automated sphygmomanometers. The reported performance for the subject device is stated to be the same as the predicate device.

Note: The document states "All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met" in section 7, "Discussion of Clinical Tests Performed." This implies the subject device met the same accuracy criteria as the predicate.

Study Information

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for the test set. It only mentions compliance with the ANSI/AAMI SP10 standard.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

• This information is not provided in the document. The ANSI/AAMI SP10 standard typically involves a comparison to a reference measurement method (e.g., auscultation by trained observers), but the specifics of the expert panel or their qualifications are not detailed here.

4. Adjudication method for the test set:

• This information is not explicitly stated in the document.

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 is not applicable to this device. The device is a blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting data with or without AI assistance.

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

• Yes, the performance evaluation described in the document for accuracy (Pressure +/- 3mmHg, Pulse +/- 5%) is a standalone performance test of the device's ability to measure blood pressure and heart rate. It operates as an "algorithm only" in the sense that its measurements are automatically generated by the device itself, without a human actively interpreting data to arrive at the measurement.

7. The type of ground truth used:

• The ground truth for blood pressure monitor accuracy studies, as typically conducted under the ANSI/AAMI SP10 standard, involves simultaneous measurements using a recognized reference standard, often referred to as "auscultatory reference pressures" obtained by trained observers. The document states compliance with ANSI/AAMI SP10:2002/(R) 2008 & ANSVAAMI SP10:2002 /A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/ A2:2006/(R) 2008, which implies that this type of ground truth was used.

8. The sample size for the training set:

• This information is not applicable as the device is not described as utilizing a machine learning algorithm that requires a "training set" in the conventional sense. The device uses an oscillometric method, which is a deterministic algorithm.

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

• This information is not applicable for the reason stated above.

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