(107 days)
HL158LA 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 wrist. The intended use of this over-the-counter device is for use by people over the age of 18 with wrist circumference ranging from approx. 5.3 to 7.7 inches(13.5 cm to 19.5 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.
HL158LA 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 wrist. All values can be read out in one LCD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3 ~ 7.7 inch (13.5 ~ 19.5 cm).
The device is equipped with Irregular Heartbeat Detector function. It will display a symbol of order to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat 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 acceptance criteria for the HL158LA Full Automatic (NIBP) Blood Pressure Monitor are primarily based on the ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/A1:2003/(R)2008 & ANSI/AAMI SP10:2002/A2:2006/(R)2008 Standard for Manual, electronic, or automated sphygmomanometers.
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (from Predicate Device/Standard) | Reported Device Performance |
|---|---|---|
| Accuracy | Pressure: +/- 3 mmHg | Meets +/- 3 mmHg |
| Pulse: +/- 5% | Meets +/- 5% | |
| Measurement Range | Pressure: 0-300 mmHg (cuff pressure) | Rated range of determination: 40-280mmHg (for blood pressure) |
| Pulse: 40-199 beats/minute | Pulse: 40-199 beats/minute |
Note: The document states "Same as left" for the accuracy of the subject device (HL158LA) when compared to the predicate device (HL158BT), indicating it meets the predicate's stated accuracy.
2. Sample size used for the test set and the data provenance:
- The document states that the device is compliant with the ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/A1:2003/(R)2008 & ANSI/AAMI SP10:2002/A2:2006/(R)2008 Standard. This standard outlines the requirements for clinical validation of automated sphygmomanometers. While the specific number of subjects is not explicitly stated in this summary, the ANSI/AAMI SP10 standard typically requires a specific number of subjects (e.g., at least 85 subjects for validation).
- Data Provenance: Not explicitly stated in the provided document. The study is described as a "clinical test" performed in compliance with an international standard, suggesting prospective data collection. There is no information about the country of origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number or qualifications of experts used. However, clinical validation studies for blood pressure monitors generally involve trained professionals (e.g., physicians, nurses) to perform the reference measurements according to established protocols like ANSI/AAMI SP10. The standard dictates the methodology for obtaining reference blood pressure measurements.
4. Adjudication method for the test set:
- The document does not explicitly mention the adjudication method. For AAMI SP10 compliance, reference blood pressure measurements are typically taken by multiple trained observers, and the average or a specific combination of their readings (often a consensus or averaging method) serves as the reference (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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was conducted. The clinical tests evaluate the accuracy of the device itself (HL158LA) in measuring blood pressure and pulse rate, comparing its readings against a validated reference method, as required by ANSI/AAMI SP10. The device operates automatically and provides readings without human intervention for interpretation beyond basic usage.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the clinical study would be reference blood pressure measurements obtained by trained observers using a validated method (e.g., auscultation with a mercury sphygmomanometer or another validated device) according to the ANSI/AAMI SP10 standard. This can be considered a form of "expert consensus" or "gold standard measurement" within the field.
8. The sample size for the training set:
- The document does not mention a "training set" in the context of an algorithm. This device uses an oscillometric method, which is a known algorithm for blood pressure measurement, but the document does not describe its development as an AI/machine learning model that requires a separate training set. The clinical study described is for validation, not training.
9. How the ground truth for the training set was established:
- As there is no mention of a "training set" for an AI/ML algorithm, this question is not applicable based on the provided document. The device relies on an established oscillometric principle rather than a continuously learning or adaptable algorithm requiring a training dataset.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).