(346 days)
Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series is for use by medical professional or at home. The WBPM15 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. The inflatable cuff circumference is limited to 13.5cm -19.5cm.
Digital Automatic Wrist Blood Pressure Monitor WBPM15 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 WBPM15 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 key components of device are a pressure sensor, electric valve and an electronic control module together with an electric pump, which inflate (and deflate) the inflatable cuff automatically according to our designed architecture.
This response is based on the provided text only, and thus cannot include details not present in the document.
Acceptance Criteria and Study for Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP-10-2002 | Meets the requirement of ANSI/AAMI SP-10-2002 |
Note: The specific numerical targets for accuracy (e.g., mean difference, standard deviation) as defined by ANSI/AAMI SP-10-2002 are not explicitly stated in the provided text, only that the device "meets the requirement" of the standard.
2. Sample Size Used for the Test Set and Data Provenance
The provided text states that a "systematic & independent clinical test was conducted," but does not specify the sample size used for this clinical test, nor does it specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications. For blood pressure monitors, ground truth is typically established by trained clinicians using a reference sphygmomanometer following a specific protocol.
4. Adjudication Method for the Test Set
The document does not specify the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. This type of study is more common for diagnostic imaging AI, not typically for blood pressure monitors.
6. Standalone Performance Study (Algorithm Only)
The device is a physical blood pressure monitor that uses an "oscillometric methodology" and "converts the movements into a digital reading." The clinical test mentioned assesses the performance of the device as a whole. While the oscillometric method involves an algorithm, the provided text does not specifically describe a standalone algorithm-only performance study separate from the overall device performance.
7. Type of Ground Truth Used
The ground truth for validating blood pressure monitors against standards like ANSI/AAMI SP-10-2002 typically involves concurrent measurements by trained human observers using a reference method (e.g., auscultation with a mercury sphygmomanometer or validated electronic reference device) following a specific protocol to obtain the true blood pressure readings. The document does not explicitly state the type of ground truth used, but this is the standard methodology for such devices.
8. Sample Size for the Training Set
The provided text does not mention a training set or its sample size. For traditional medical devices like blood pressure monitors, "training data" in the AI sense is not typically used. The device relies on established oscillometric principles rather than a learned AI model that requires a training set.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned or implied within the context of a traditional blood pressure monitor, this information is not applicable and not provided in the document.
§ 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).