(56 days)
The Wrist Watch Blood Pressure Monitor, Model BP3NN1-3E is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm.
The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.
Microlife Wrist Watch Blood Pressure Monitor, Model BP3NN1-3E is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".
The device can detect electrical signals while inflating . And the device has Irregular Heartbeat Detection (IHD) function. It detects the appearance of irregular heartbeat during measurement and the irregular heart beat symbol "MA" is displayed on the LCD screen if any irregular heart beat signal has been detected. In addition, the device has traffic light function.
This document describes the Microlife Wrist Watch Blood Pressure Monitor, Model BP3NN1-3E, and its substantial equivalence to predicate devices, particularly concerning its performance characteristics.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than explicitly stating acceptance criteria and then presenting a direct comparison. However, the regulatory standards cited implicitly define the acceptance criteria for non-invasive blood pressure measurement devices.
The key performance aspect mentioned is the blood pressure measurement accuracy and the Irregular Heartbeat Detection (IHD) function.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Blood Pressure Measurement Accuracy: Meets the accuracy requirements of relevant standards (e.g., AAMI/ANSI SP10, EN 1060-1, EN 1060-3, AAMI/ANSI/IEC 80601-2-30). These standards outline limits for mean difference and standard deviation between the device's readings and a reference method. | The document states: "The subject device Model BP3NN1-3E is from the technical point of view, identical to the predicate blood pressure monitor. Moreover, the measurement algorithm and its program codes of BP3NN1-3E remain unchanged. The fundamental scientific technology of the modified BP3NN1-3E device is the same as the predicate device BP3MO1-3P. Therefore the performance of the BP3NN1-3E in terms of blood pressure measurement would be identical with performance of the predicate device BP3MO1-3P." This implies the device meets the same accuracy as the predicate, which previously met these standards. |
| Irregular Heartbeat Detection (IHD) Functionality: Detects the appearance of irregular heartbeat during measurement and provides a warning signal. | "The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected." The device has an "Irregular Heartbeat Detection (IHD) function" and displays the symbol "MA" on the LCD. |
| Electrical, Mechanical, and Environmental Performance: Meets safety and performance requirements outlined in standards (e.g., IEC 60601-1, IEC 60601-1-2). | "Testing information demonstrating safety and effectiveness... is supported by testing that was conducted in accordance with the FDA November 1993 Draft 'Reviewer Guidance for Premarket Notification Submissions', DCRND, which outlines Electrical, Mechanical and Environmental Performance requirements." It specifically lists compliance with several IEC standards. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Repeat clinical testing in accordance with the standard ANSI/AAMI IEC81060-2 for the subject device BP3NN1-3E is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device."
Therefore, a new, separate clinical test set for the BP3NN1-3E model was not used for demonstrating blood pressure measurement accuracy. The reliance is on the clinical data for the predicate device BP3MO1-3P.
- Sample Size for Test Set: Not applicable for the BP3NN1-3E's blood pressure measurement accuracy. The performance is inferred from the predicate device (BP3MO1-3P). The document does not specify the sample size for the predicate's original clinical study, nor its data provenance.
- Data Provenance: Not applicable for a new clinical study of the BP3NN1-3E. For the predicate device, it is not specified in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided for the BP3NN1-3E device as a new clinical study for blood pressure measurement accuracy was deemed unnecessary. For the predicate device's original clinical validation, this detail is absent from the provided text.
4. Adjudication Method for the Test Set
This information is not provided for the BP3NN1-3E device as a new clinical study for blood pressure measurement accuracy was deemed unnecessary. For the predicate device, this detail is absent from the provided text.
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 is not applicable. The device described is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers or comparative effectiveness studies of the type described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone evaluation of the device's performance is implied. The document states that the "Microlife Wrist Watch Blood Pressure Monitor, Model BP3NN1-3E is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique". The performance is based on the device's algorithms and hardware, without requiring human interpretation for the primary blood pressure measurement task.
7. The Type of Ground Truth Used
For blood pressure measurement devices, the ground truth for clinical accuracy studies (such as those done for the predicate device) typically involves simultaneous measurements by trained observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer or validated electronic reference device), following a rigorous protocol (like the ANSI/AAMI/ISO 81060-2 standard).
8. The Sample Size for the Training Set
This information is not provided. The document does not discuss a "training set" in the context of machine learning. The device uses an "oscillometric method" with "measurement algorithm and its program codes" which, while involving signal processing, is described as a "well-known technique" rather than a system trained on a specific dataset in the modern AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as the concept of a "training set" in the context of an AI/machine learning model is not explicitly discussed for this device. The underlying oscillometric method and algorithms would have been developed and validated over time based on physiological principles and empirical data, but not necessarily through a formal "training set" with established ground truth as understood in current AI development.
§ 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).