(37 days)
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.
| Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| Pressure Accuracy | +/- 3mmHg | +/- 3mmHg |
| Pulse Accuracy | +/- 5% | +/- 5% |
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.
§ 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).