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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual with arm circumference sizes ranging from 22 -42 cm by using a non-invasive oscillometric technique which an inflatable cuff is wrapped around the single 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 memory data can be transferred to the PC (personal computer) running the Microlife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth.

The blood pressure monitor is a fully automatic digital blood pressure measuring device used by adults on the upper arm at home.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 22 -42 cm 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 detects the appearance of irregular heartbeat during measurement. and the symbol " *is displayed after the measurement. In addition, the memory data can be transferred to the PC (personal computer) running the Microlife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth.

The blood pressure monitor is a fully automatic digital blood pressure measuring device use by adults on the upper arm at home.

The provided document is a 510(k) premarket notification for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y. It details the device's indications for use, comparison to predicate devices, and testing performed to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. However, it indicates compliance with the accuracy requirements of the ANSI/AAMI/ISO 81060-2 standard for non-invasive sphygmomanometers. This standard itself defines the acceptance criteria for blood pressure measurement accuracy.

The document states: "The subject clinical validation test report according to the standard ANSI/AAMI/IEC 81060-2 also proved the accuracy of blood pressure detection."

2. Sample Size Used for the Test Set and Data Provenance

The document states that a clinical validation study was conducted "in accordance with the standard ANSI/AAMI/ ISO 81060-2" for the subject device. However, it does not explicitly state the sample size used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective).

It refers to leveraging the clinical validation test report of a predicate device (BP3MS1-4A, K153450), stating: "the subject device BP3MW1-4Y can leverage the clinical validation test report of BP3MS1-4A (BP A200 Comfort)." While it mentions that "Clinical testing in accordance with the standard ANSI/AAMI/ ISO 81060-2 was conducted for the subject device," it primarily relies on the predicate's testing due to the technological similarities.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used to establish ground truth or their qualifications. The ANSI/AAMI/ISO 81060-2 standard typically requires comparison against a reference measurement (often auscultatory measurements performed by trained observers) but the details of these observers are not provided here.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for establishing the ground truth measurements. In studies following ANSI/AAMI/ISO 81060-2, multiple independent observers typically perform auscultatory measurements, and an adjudication method (like averaging or a qualified third party resolving discrepancies) is used. This information is not present in 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is typically done for diagnostic imaging devices where human readers interpret medical images, and the AI assists in that interpretation. This device is an automatic digital blood pressure monitor, not an AI-assisted diagnostic imaging tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was done. The device itself is an "Automatic Digital Blood Pressure Monitor," implying it operates autonomously to measure blood pressure without constant human intervention in the measurement process. The clinical validation, in accordance with ANSI/AAMI/ISO 81060-2, assesses its accuracy in determining systolic and diastolic blood pressure.

7. The Type of Ground Truth Used

The ground truth used for blood pressure monitors is typically reference blood pressure measurements obtained by auscultation (manual sphygmomanometry), performed by trained observers, as specified by standards like ANSI/AAMI/ISO 81060-2. The document mentions compliance with this standard, implying this type of ground truth was used.

8. The Sample Size for the Training Set

This device relies on an "oscillometric method" with an algorithm to determine blood pressure. While algorithms often involve a "training" phase, the document does not specify a training set size. For traditional medical devices like blood pressure monitors, the algorithm is often developed and validated using a cohort of subjects, but it's not typically referred to as a "training set" in the same way machine learning models are. The focus is on the clinical validation of the final algorithm's performance.

9. How the Ground Truth for the Training Set Was Established

As no specific training set is outlined in the context of this traditional device, the document does not describe how ground truth for a training set was established. If algorithmic development involved data, the ground truth would similarly be established by reference blood pressure measurements (auscultation).

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