(118 days)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R) is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual by using a non-invasive oscillometric technique in one inflatable cuff is wrapped around the single upper arm.
The device detects the appearance of irregular heartbeat during measurements, and gives a warning signal with the reading once the irregular heartbeat is detected.
The device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.
The device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R) is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert 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 accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.
The device detects the appearance of irregular heartbeat during measurement, and the symbol " " "is displayed after the measurement. In addition, the device can be used in connection with your personal computer (PC) running the software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable.
Here's a breakdown of the acceptance criteria and study information for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance Criteria (Standard/Protocol) | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy (Systolic & Diastolic) | ANSI/AAMI/ISO 81060-2:2009 validation criteria (and AAMI SP10 protocol) | Satisfied the validation criterion of the AAMI SP10 protocol. |
| Accuracy in Pregnant Patients (including preeclampsia) | ANSI/AAMI/ISO 81060-2:2009 protocol | Device "can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia." |
| Irregular Heartbeat Detection | (No specific numerical criterion provided, just detection functionality) | Detects the appearance of irregular heartbeat and displays a symbol/warning. |
| Electrical, Mechanical, Environmental Performance | FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND | Met all relevant requirements of the aforementioned tests (Reliability, EMC, IEC 60601-1 Safety). |
| Software Validation | FDA November 2005 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (moderate level of concern) and FDA September 1999 "Guidance for Off-The-Shelf Software Use in Medical Devices" | Software validation conducted in accordance with these guidances. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions clinical validation reports but does not explicitly state the sample size used for the clinical test set.
- Sample Size (Test Set): Not explicitly stated in the provided text for the clinical validation or other tests.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical validation report," implying prospective clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. The document refers to the ANSI/AAMI/ISO 81060-2:2009 and AAMI SP10 protocols for blood pressure measurement validation, which typically involve a specific number of observers (experts) for reference measurements. However, the exact number and qualifications of these experts are not detailed in this summary.
4. Adjudication Method for the Test Set
This information is not provided in the text. The AAMI protocols typically have specific requirements for how reference measurements are compared and adjudicated, but the summary does not elaborate on this for this specific study.
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
There is no indication of an MRMC comparative effectiveness study involving human readers or AI in this document. This device is an automatic digital blood pressure monitor, not an AI-assisted diagnostic imaging or interpretation tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the primary clinical testing described is a standalone validation of the device's accuracy in measuring blood pressure and detecting irregular heartbeats, according to the ANSI/AAMI/ISO 81060-2:2009 protocol. This protocol evaluates the device's performance without human interpretation or assistance beyond the typical operation of a blood pressure monitor.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the blood pressure accuracy validation, the ground truth would be established through reference measurements taken by trained observers using a calibrated sphygmomanometer (or similar reference method) according to the ANSI/AAMI/ISO 81060-2:2009 protocol. This often involves simultaneous or nearly simultaneous measurements with the test device and a highly accurate reference method. For "irregular heartbeat detection," the ground truth would likely be established by a physician's or cardiologist's diagnosis using an ECG or other standard diagnostic methods.
8. The Sample Size for the Training Set
This device is based on the "oscillometric method," which is a well-known and established technique for blood pressure measurement. While software is involved in analyzing the signals, the document does not suggest a machine learning model that would require a distinct "training set" in the modern sense (i.e., for deep learning or AI). The software algorithm is described as using the "well-known oscillometric method." Therefore, the concept of a separate "training set" for an AI model, as typically understood, does not apply in this context.
9. How the Ground Truth for the Training Set Was Established
As explained under point 8, the concept of a "training set" for an AI model with a distinct ground truth establishment method is not applicable to this device. The oscillometric method itself is based on established physiological principles and signal analysis techniques, not a data-driven machine learning training process described 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).