(48 days)
Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series is for use by medical professional or at home. The WBPM10 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist of an individual.
Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual in each measurement and then displays the readings on a digital panel. The WBPM10 Series utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the wrist of an individual, for the blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movements into a digital reading.
The provided text describes the acceptance criteria and the study conducted for the Grandway Technology (Shenzhen) Limited Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets the requirement of ANSI/AAMI SP-10-2002 | The clinical test results demonstrated that WBPM10 Series meets the requirement of ANSI/AAMI SP-10-2002. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "A systematic & independent clinical test was conducted to validate the performance," but it does not specify the sample size used for this clinical test.
Regarding data provenance, the document does not explicitly state 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 Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth for the clinical test. However, for a device validating against a standard like ANSI/AAMI SP-10-2002, blood pressure measurements from trained healthcare professionals are typically considered the reference.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
An MRMC comparative effectiveness study was not conducted. The study was a clinical validation against a standard, not a comparison of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
Yes, a standalone study was done. The device itself is an automated blood pressure monitor; its performance was evaluated inherently as a standalone algorithm/device without human intervention in the measurement process. The clinical test evaluated the device's accuracy in measuring blood pressure against a recognized standard.
7. The Type of Ground Truth Used
The ground truth used was measured blood pressure readings from a reference method as per the ANSI/AAMI SP-10-2002 standard. This standard typically requires comparative measurements against a sphygmomanometer used by trained observers.
8. The Sample Size for the Training Set
The document does not specify the sample size for any training set. As this is a medical device and not an AI model in the modern sense of deep learning, it's unlikely there's a "training set" in the context of machine learning. The device employs an oscillometric methodology, which is a well-established principle, and its "training" would be more akin to calibration and design optimization rather than learning from a large dataset.
9. How the Ground Truth for the Training Set was Established
As noted above, the concept of a "training set" with established ground truth in the machine learning sense is not explicitly mentioned or implied for this device. The oscillometric methodology relies on detecting oscillations in pressure in the cuff, and the "ground truth" for its development would be based on fundamental physiological principles and engineering design, coupled with iterative testing and refinement. The clinical validation against ANSI/AAMI SP-10-2002 serves to ensure the designed system accurately translates these oscillations into blood pressure readings.
§ 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).