(66 days)
HL858CB automatically measuers 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.
HL858CB detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring reading. And the device features a built-in "Bluetooth Data Transmission'' function, which enables the device automatically transmit measuring results to paired Bluetooth device.
HL858CB 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 wor 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. 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 ( & TIME ) 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.
Here's a breakdown of the acceptance criteria and the study details for the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CB, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The primary performance criteria for accuracy are based on ISO 81060-2: First Edition 2009-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation thresholds) are not explicitly listed in the provided document, the summary states: "The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device HL858CB in the group of 90 subjects with qualified distribution."
Therefore, the table would look like this:
| Acceptance Criteria Category | Specific Acceptance Criteria (based on ISO 81060-2) | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy | Required limits for mean difference and standard deviation (defined by ISO 81060-2) | Fulfilled by the device |
| Pulse Accuracy | Pressure ± 3mmHg | Same as predicate device (not explicitly re-tested based on this document, but established for predicate) |
| Pulse ± 5% | Same as predicate device (not explicitly re-tested based on this document, but established for predicate) |
Note: The document focuses on showing substantial equivalence to predicate devices, and the accuracy specifications for pressure and pulse are listed as "Same as left" when comparing to the predicate device HL858CA (K131121). Therefore, the reported performance for these is assumed to meet the same specifications as the predicate. The ISO 81060-2 study directly addresses the overall accuracy.
2. Sample size used for the test set and the data provenance
- Sample Size: 90 subjects
- Data Provenance: Not explicitly stated (e.g., country of origin), but it was a "clinical investigation," implying prospective collection for the purpose of validating the device. The nature of the study (clinical validation of automated measurement type) suggests a prospective study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications for establishing ground truth. ISO 81060-2 generally requires trained evaluators for reference measurements, but the specifics are not detailed in this summary.
4. Adjudication method for the test set
The document does not specify an adjudication method. ISO 81060-2 protocols often involve multiple reference measurements against which the device is compared, but an explicit adjudication between different measurements or readers is not mentioned.
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 device is a Full Automatic (NIBP) Blood Pressure Monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The entire clinical validation described by compliance with ISO 81060-2 is a standalone performance study of the device's accuracy in measuring blood pressure and pulse without human intervention in the measurement process (other than initiating it and positioning the cuff).
7. The type of ground truth used
The ground truth for the clinical validation according to ISO 81060-2 typically involves auscultatory measurements performed by trained observers using a reference sphygmomanometer (mercury or calibrated aneroid) with a stethoscope. This is considered "expert reference measurement" or "clinical reference."
8. The sample size for the training set
The document does not mention a training set because this is a hardware device with a fixed algorithm, not a machine learning model that requires training. The "development" or "calibration" of the algorithm would have occurred during the device's design and engineering phase, separate from the clinical validation.
9. How the ground truth for the training set was established
As there is no "training set" in the context of a machine learning model, this question is not applicable. The ground truth for the clinical validation (test set) would have been established via expert reference measurements as described in point 7.
§ 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).