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The Upper Arm Blood Pressure Monitor, Model BP3K V 1-5K 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 upper arm for a circumference range from 17 to 52cm.

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 a smart phone via Bluetooth or with a personal computer (PC) via USB. The measurement data can be transferred to a smart phone running the Microlife Connected Health+ mobile software (App) or a PC running the Microlife BP Analyzer+ (BPA+) software.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5K is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 17-52 cm by using a noninvasive 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 using 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 detects the appearance of irregular heartbeat during measurement, and the symbol " " is displayed with the reading. The device can 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.

This document is a 510(k) Premarket Notification for a blood pressure monitor, not an AI/ML powered medical device. Therefore, the information typically requested regarding acceptance criteria, study design for AI models, and clinician performance with/without AI assistance cannot be extracted from this document, as it is not applicable.

The document discusses the substantial equivalence of the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5K, to predicate devices. The acceptance criteria in this context refer to engineering and clinical performance standards for blood pressure monitors as defined by various international standards (e.g., AAMI/ANSI/IEC 80601-2-30 for non-invasive sphygmomanometers), rather than performance metrics for an AI algorithm.

Below, I'll structure the answer to address the prompt's points based on the information available in the document for a traditional medical device, noting where AI-specific information is not present.

Device: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5K

This device is a traditional non-invasive blood pressure monitor that uses an oscillometric technique. It does not employ artificial intelligence or machine learning for its core blood pressure measurement function. Therefore, many of the questions asked, which are relevant to AI/ML powered devices, are not applicable here.

1. A table of acceptance criteria and the reported device performance

The document states that the device was tested to meet relevant national and international standards for electrical, mechanical, environmental performance, and basic safety and essential performance of automated non-invasive sphygmomanometers. While specific numerical acceptance criteria (e.g., mean difference and standard deviation per ISO 81060-2) are not provided in this summary, the document asserts that the device met all relevant requirements.

Table: General Acceptance Criteria and Stated Performance (Based on Document)

2. Sample size used for the test set and the data provenance

The document states that repeated clinical testing for the subject device (BP3KV1-5K) was not necessary. Instead, the clinical validation of the predicate devices (BP3MW1-4Y and BP3MS1-4A), performed according to ANSI/AAMI/ISO81060-2, was deemed applicable.

Therefore, the specific sample size for a test set for the subject device's core BP measurement accuracy is not mentioned as a new study was not performed. The data provenance would be from the original clinical validation studies performed for the predicate devices. The document does not specify country of origin or whether these prior studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this device, as it is not an AI/ML device requiring expert consensus for ground truth or interpretation. The "ground truth" for blood pressure measurement devices is typically a reference measurement method (e.g., auscultatory method by trained observers) used during clinical validation studies (like those following ISO 81060-2). The document does not provide details on the number or qualifications of experts involved in the predicate device's clinical validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this refers to adjudication for expert labeling/ground truth in AI/ML model validation, which is not relevant for this traditional blood pressure monitor.

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

Not applicable. This device is not an AI-powered diagnostic tool, so an MRMC study comparing human performance with and without AI assistance was not performed.

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

This refers to the performance of an AI algorithm intrinsically. For this traditional blood pressure monitor, the "algorithm" is the oscillometric measurement technique. Its performance is evaluated through clinical validation against a reference method (human observers using auscultation), which is essentially a standalone performance evaluation of the device's measurement accuracy. The document states that the clinical validation for the predicate devices is applicable and meets the ANSI/AAMI/ISO81060-2 standard.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For traditional blood pressure monitors, the ground truth in clinical validation studies is typically established by simultaneous measurements using a recognized reference method, such as the auscultatory method performed by trained human observers using a mercury sphygmomanometer or validated electronic reference device. This is the standard approach for studies structured according to ISO 81060-2.

8. The sample size for the training set

Not applicable. This device does not use an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no AI/ML training set for this device.

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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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