(120 days)
HL888HD 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 use by people over the age of 18 with arm circumference ranging from approx.9 inches to 17 inches (23 cm to 43 cm) and for home use.
HL888HD features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement.
HL888HD 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 use by people over the age of 18 with arm circumference ranging from approx. 9 inches to 17 inches (23 cm to 43 cm) and for home use.
The user is able to set the personal target values for blood pressure self-management. When the user's blood pressure readings exceed the self management pressure level, a RED LCD backlight of either systolic/diastolic or both will illuminate. If the readings are equal or lower than the preset values, the screen will illuminate BLUE LCD backlight.
User's measuring results can be automatically transmitted to the paired Bluetooth device via the built-in Bluetooth module once measurement completed.
The provided text describes the 510(k) premarket notification for the Full Automatic (NIBP) Blood Pressure Monitor, Model HL888HD. The primary study referenced is for compliance with the ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002 /A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/ A2:2006/(R) 2008 Manual, electronic or automated sphygmomanometers Standard.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
According to the ANSI/AAMI SP10:2002 standard, the acceptance criteria for blood pressure monitors are typically:
- Pressure Accuracy: The mean difference between the device reading and the reference method should be ≤ ± 5 mmHg, with a standard deviation of ≤ 8 mmHg.
- Pulse Rate Accuracy: Usually specified as ± 5% or a similar tolerance compared to a reference standard.
The "Accuracy" section in the Product Specification Comparison Table directly states the device's performance against these criteria:
| Acceptance Criteria (from ANSI/AAMI SP10) | Reported Device Performance (HL888HD) |
|---|---|
| Pressure: Mean Difference ≤ ± 5mmHg, Standard Deviation ≤ 8mmHg | Pressure: +/- 3mmHg |
| Pulse: ± 5% (typical) | Pulse: +/- 5% |
Note: The "Pressure +/- 3mmHg" stated is often the mean difference accuracy. The text directly states the device meets this, implying it also meets the standard's statistical requirements (mean difference and standard deviation) for accuracy due to the claim "All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical validation according to the ANSI/AAMI SP10 standard. The standard itself specifies the minimum number of subjects required for validation (e.g., typically at least 85 subjects with specific distributions across age, gender, and blood pressure ranges).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, clinical studies for medical device approval are generally prospective to ensure controlled data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The text does not provide information on the number of experts or their qualifications for establishing ground truth in the clinical validation. For oscillometric blood pressure monitors validated against a standard like ANSI/AAMI SP10, the "ground truth" (or reference standard) is typically established by trained observers using a mercury or auscultatory sphygmomanometer following a defined protocol, often in a double-blind fashion, as per the standard's requirements. These observers are highly trained healthcare professionals or technicians.
4. Adjudication Method for the Test Set
The text does not explicitly state the adjudication method used. For blood pressure validation studies using auscultatory reference, there are often two or more independent observers, and their readings are compared. If they differ by a certain amount, a third observer might be involved, or the readings averaged, but this specific detail is not in the provided summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done or reported. This type of study typically compares human reader performance with and without AI assistance, which is not applicable to a standalone blood pressure monitor.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone study was done. The device itself is an automated blood pressure monitor that measures blood pressure autonomously. The clinical tests performed "demonstrated that the predetermined acceptance criteria were fully met," indicating that the device's algorithm performs accurately without human intervention during the measurement process. The comparison of the device's readings against a human-obtained reference (as per ANSI/AAMI SP10) is a standalone performance assessment.
7. The Type of Ground Truth Used
The type of ground truth used for the clinical validation is based on reference measurements obtained simultaneously by trained observers using a reference auscultatory method, generally following the protocols outlined in the ANSI/AAMI SP10 standard. This is implicitly confirmed by the device's claim of compliance with this standard.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for any training set. For devices like this, the "training set" would refer to data used for the development and calibration of the oscillometric algorithm. This information is typically proprietary and not usually disclosed in a 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any training set was established. Similar to the test set, it would have been established through simultaneous measurements by trained observers using a reference auscultatory 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).