(101 days)
This device automatically measures human's Systolic 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.
HL868RT 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 additional optional talking function equipped of this device can help the user to know how to use the device to measure the blood pressure and the pulse step by step, and let the user know the measurement results by hearing. Besides, the device will display a symbol if the difference between the longest and shortest heartbeat intervals 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pressure Accuracy: +/- 3mmHg | Compliant to ANSI/AAMI SP-10:2002+A1:2003+A2:2006 Standard |
| Pulse Accuracy: +/- 5% | Compliant to ANSI/AAMI SP-10:2002+A1:2003+A2:2006 Standard |
| Safety Testing | Compliant to IEC 60601-1:1988+A1:1991+A2:1995 |
| EMC Testing | Compliant to IEC 60601-1-2:2001+A1:2004 |
| Reliability Testing | Compliant to ANSI/AAMI SP-10:2002+A1:2003+A2:2006 |
| Risk Assessment | Compliant to ISO 14971:2007 |
| Software V&V | Compliant to IEC 62304 Ed. 1.0; IEC 60601-1-4:2000 |
| Usability Validation | Compliant to IEC 62366 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the clinical test set, nor does it specify the country of origin or whether the data was retrospective or prospective. It only mentions that the device is compliant with ANSI/AAMI SP-10:2002+A1:2003+A2:2006 Standard for Manual, electronic, or automated sphygmomanometers, which would dictate the required number of subjects for clinical validation. This standard generally requires a minimum of 85 subjects for blood pressure device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any specific clinical test set. The compliance to the ANSI/AAMI SP-10 standard usually implies the use of reference measurements taken by trained observers using auscultation, which serves as the "ground truth."
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like 2+1 or 3+1. For blood pressure device validation against the ANSI/AAMI SP-10 standard, the "ground truth" is typically established by trained observers taking mercury sphygmomanometer readings, not through a consensus of multiple reviewers of the device's output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
This section is not applicable to the provided device. The HL868RT is a standalone blood pressure monitor and does not involve AI assistance for human readers or interpretation of medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The device itself, the Full Automatic (NIBP) Blood Pressure Monitor, Model HL868RT, is designed to provide blood pressure and heart rate measurements automatically using the oscillometric method. Its performance was tested and found compliant with relevant standards like ANSI/AAMI SP-10. This indicates a standalone assessment of its accuracy against a reference measurement.
7. The Type of Ground Truth Used
Based on the compliance to the ANSI/AAMI SP-10:2002+A1:2003+A2:2006 Standard, the ground truth for blood pressure measurements would be established using reference measurements from trained observers using auscultation with a mercury sphygmomanometer.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. This type of non-invasive blood pressure monitor typically relies on established algorithms and calibration methods rather than a "training set" in the machine learning sense. The underlying algorithms are developed and refined based on extensive physiological and engineering principles, then validated for accuracy with clinical testing.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the machine learning context is not explicitly mentioned or implied for this device, the concept of establishing ground truth for a training set is not applicable in this submission. The accuracy of the device's measurements is validated against established clinical standards (ANSI/AAMI SP-10) where the gold standard for blood pressure is determined by trained human observers using a reference method.
§ 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).