(52 days)
HL858CC 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.
HL858CC 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 screen for 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, user 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.
HL858CC 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.
The device will display a symbol wor 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. 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 (& THE) 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. Furthermore, the user can use the Bluetooth Data Transmission function, which provides users an optional choice to log, track and store their measurement data. Also 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.
The provided text describes the acceptance criteria and the study conducted for the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CC.
1. Table of Acceptance Criteria and Reported Device Performance:
| Criterion | Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy | Pressure ± 3mmHg | "The required limits for mean difference and standard deviation are fulfilled by the subject device HL858CC..." |
| Pulse Accuracy | Pulse ± 5% | "The required limits for mean difference and standard deviation are fulfilled by the subject device HL858CC..." |
| Adherence to ISO Standard | ISO 81060-2: Second Edition 2013-05-01 compliant | "HL858CC is compliant to the standard of ISO 81060-2: Second Edition 2013-05-01..." |
| Functional Performance | Measures Systolic, Diastolic BP, Heart Rate via oscillometric method during inflation, detects irregular heartbeats, Risk Category Indicator, Bluetooth data transmission. | The device performs these functions as described in the "Device Description" and "Intended Use" sections. The study confirms compliance with standards. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 105 subjects.
- Data Provenance: The document does not specify the country of origin of the data. The study is a clinical investigation, indicating it is likely prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not explicitly state the number of experts or their specific qualifications for establishing ground truth for the clinical validation. It mentions "all the relevant activities were performed by designate individual(s)", which is vague. In typical blood pressure monitor validation studies (like ISO 81060-2), ground truth is established by trained professionals (e.g., clinicians, nurses) using a reference sphygmomanometer.
4. Adjudication Method for the Test Set:
The document does not explicitly describe an adjudication method like 2+1 or 3+1. For blood pressure clinical validation according to ISO 81060-2, multiple measurements are typically taken by the reference method and the device, and the differences are calculated. The standard defines the statistical analysis (mean difference and standard deviation) to determine accuracy, which implicitly involves comparing the device's readings against highly accurate manual readings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a clinical validation of the device's accuracy against a reference standard, not a comparison of human reader performance with and without AI assistance.
6. Standalone Performance:
Yes, a standalone performance study was done. The clinical investigation directly assessed the accuracy of the HL858CC device itself against a clinical reference standard, without human-in-the-loop assistance. The results demonstrated that the device alone met the predetermined acceptance criteria for accuracy.
7. Type of Ground Truth Used:
The ground truth used for the clinical investigation (ISO 81060-2) would be reference blood pressure measurements, typically obtained using a mercury sphygmomanometer or another validated reference oscillometric device by trained clinical personnel. The document does not explicitly state "mercury sphygmomanometer" but refers to "Clinical validation of automated measurement type," which implies comparison against a gold standard method.
8. Sample Size for the Training Set:
The document does not provide any information regarding a training set or its sample size. This is a clinical validation study for a medical device (blood pressure monitor), not a machine learning model that typically requires a separate training set.
9. How the Ground Truth for the Training Set Was Established:
Since no training set is mentioned (as the device is not described as involving a machine learning model that would require one for development), this information is not applicable/provided. The study focuses on clinical validation of the device's accuracy.
§ 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).