(142 days)
iHealth BP3 Fully Automatic Arm Cuff Electronic Blood Pressure Dock is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
iHealth BP3 Fully Automatic Arm Cuff Electronic Blood Pressure Dock is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm. iHealth BP3 Fully Automatic Arm Cuff Electronic Blood Pressure Dock is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphyqmanometers. The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irreqular heartbeat is detected, it can be shown to the user. More over, it also obtains the function of averaging the measurement results. iHealth BP3 Fully Automatic Arm Cuff Electronic Blood Pressure Dock achieves its function by integrate the device with an iPhone, ipod or ipad. For it does not contain an LCD or other display components, so It's necessary for the new device to connect to an iPhone, ipod or ipad containing a support software to constitute a complete blood pressure measurement system.
Here's an analysis of the provided text regarding the acceptance criteria and study for the iHealth BP3 Fully Automatic Arm Cuff Electronic Blood Pressure Dock:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the iHealth BP3 are based on compliance with the ANSI/AAMI SP10 standard for manual, electronic, or automated sphygmomanometers. While the document doesn't provide a specific numerical table of acceptance criteria and the device's numerical performance against each, it states a blanket compliance.
| Acceptance Criteria (from ANSI/AAMI SP10) | Reported Device Performance |
|---|---|
| All applicable requirements of ANSI/AAMI SP10 | Device met all applicable requirements of the standard. |
(Note: The document doesn't provide the explicit numerical performance values as would be typical for accuracy studies, but rather asserts compliance with the standard's requirements.)
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "a new clinical test is done in accordance with ANSI/AAMI SP10," but does not specify the number of subjects or measurements included in this test.
- Data Provenance: Not explicitly stated. The document indicates the submitting company is based in Tianjin, P.R. China, but does not confirm where the clinical test was conducted or if the data was retrospective or prospective. Given it was a "new clinical test," it was likely prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not explicitly stated. The ground truth for blood pressure measurements in accordance with ANSI/AAMI SP10 typically involves simultaneous measurements by trained personnel using a reference sphygmomanometer. However, the number and qualifications of these "experts" (e.g., clinicians, trained observers) are not mentioned in this document.
4. Adjudication Method for the Test Set
Not explicitly stated. For blood pressure clinical trials, adjudication often involves averaging multiple expert readings or using a standard auscultatory method as reference. This document does not detail such a method.
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
Not applicable. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic imaging or analysis tool that would typically involve human readers or MRMC studies. Its primary function is to directly measure blood pressure.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in principle. The clinical test described is likely a standalone performance validation of the device's algorithm and hardware. The device itself (when connected to an iPhone/iPod/iPad) automatically measures and reports blood pressure; it doesn't require human interpretation of complex data for a diagnosis, but rather provides a direct measurement. The "algorithm" for calculating systolic and diastolic pressure has changed from the predicate device (inflation detection vs. deflation detection), which necessitated this new clinical test.
7. The Type of Ground Truth Used
The ground truth used would have been a reference measurement from a validated sphygmomanometer performed by trained observers, as prescribed by the ANSI/AAMI SP10 standard. This is a form of expert reference measurement, but not "pathology" or "outcomes data" in the typical sense for diagnostic devices.
8. The Sample Size for the Training Set
Not applicable. This device is a measurement system, not a machine learning model that requires a "training set" in the conventional sense. The "arithmetic" (algorithm) for inflation detection would have been developed and refined through engineering and calibration, not through a data-driven training process in the same way an AI algorithm for image recognition would be.
9. How the Ground Truth for the Training Set was Established
Not applicable for the reasons stated above. The "ground truth" for developing the measurement algorithm would come from physical principles of blood pressure measurement and engineering standards, not a labeled dataset for training a statistical model.
§ 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).