(108 days)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC is a device intended to measure the systolic and diastolic blood pressure 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 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 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 Blood Pressure Monitor, Model BP3MC1- PC is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive MAM (Microlife Average Mode) technique in which an inflatable cuff is wrapped around the Upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure 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 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 Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.
Here’s a breakdown of the acceptance criteria and study information for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP10-2002 "National Standard for Manual. Electronic or Automated Sphygmanometers" | The BP3MC1-PC met all relevant requirements of this standard, as applicable to the modified device. |
Note: The document explicitly states that "All relevant sections were addressed and testing conducted." and that the device "met all relevant requirements." However, specific numerical performance metrics (e.g., mean difference, standard deviation) for accuracy against the standard are not provided in this summary. The summary focuses on compliance with the standard rather than detailed performance numbers. Also, the document indicates that "Repeat testing was not performed for the modified device, as clinical testing results were not affected by the changes to the modified device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "testing was conducted in accordance with the FDA November 1993 Draft 'Reviewer Guidance for Premarket Notification Submissions'" and that "ANSI/AAMI SP10-2002" testing was performed. These standards typically specify patient recruitment and testing protocols, but the exact number of subjects or measurements is not provided in this summary.
- Data Provenance: Not explicitly stated. It is implied that the clinical testing was conducted in a manner consistent with FDA and AAMI standards, which usually involve prospective studies for device validation. The country of origin is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. For blood pressure monitors, ground truth often involves comparison with a reference method (e.g., auscultation by trained observers), but the specifics of who performed this or their qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was performed. The device itself is an automated blood pressure monitor that uses an algorithm ("oscillometric method") to determine systolic and diastolic blood pressure and pulse rate. The clinical testing against ANSI/AAMI SP10-2002 evaluates the accuracy of this algorithm as embodied in the device.
7. The Type of Ground Truth Used
The ground truth used for clinical testing would typically be established by a reference method, most commonly auscultation by trained observers using a mercury sphygmomanometer or an equivalent validated device, as per the ANSI/AAMI SP10 standard for non-invasive blood pressure monitors. This acts as the "gold standard" against which the oscillometric device's readings are compared. The document states the device's method is "similar to the auscultatory method."
8. The Sample Size for the Training Set
This information is not provided and is generally not applicable in the same way for these types of oscillometric blood pressure devices as it would be for machine learning or AI models developed directly from data. The "training" for such a device involves the development and calibration of the oscillometric algorithm itself, which is based on established physiological principles and extensive prior engineering, rather than a distinct "training set" of patient data as understood in modern AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of a "training set" for a continually learning AI model. The oscillometric algorithm's development and internal validation would rely on established physiological models of cuff pressure changes in relation to arterial pressure, likely refined through engineering tests and initial clinical studies, rather than a dedicated "training set" with established ground truth listed in this type of summary.
§ 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).