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The Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) 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 22 to 40cm. 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. The measurement data can be transferred to a smart phone running the Microlife Connected Health+ mobile software (App).

The Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 22 to 40 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 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 after the measurement. In addition, the device can be used in connection with smart mobile devices running the Microlife Connected Health+ mobile software (App) 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 FDA 510(k) clearance letter and summary for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B), include information about its testing and equivalence to a predicate device. However, it does not contain explicit acceptance criteria thresholds (e.g., specific accuracy ranges for blood pressure measurements) or detailed results beyond stating that the device "met all relevant requirements" and "results were passing."

Based on the provided text, here's an attempt to extract the requested information, with notable gaps where details are not explicitly stated.

Acceptance Criteria and Study Details for Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for blood pressure accuracy (e.g., mean difference and standard deviation standards like those in ISO 81060-2). It only mentions that the device "met all relevant requirements" and "results were passing" according to the relevant standards.

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

• Sample Size: The document does not specify the exact sample size for the clinical validation study conducted in accordance with ISO 81060-2.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Typically, such clinical validations are prospective, but this is not explicitly stated.

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

• The document does not provide details on the number or qualifications of experts used for establishing ground truth, as is typical for an oscillometric blood pressure monitor validation. For ISO 81060-2, readings are independently taken by multiple trained observers, but their specific qualifications (e.g., experience level) are not detailed here.

4. Adjudication Method for the Test Set

• The document does not explicitly state an adjudication method. For ISO 81060-2, the ground truth (reference blood pressure) is established by two or more trained observers using auscultation. Discrepancies between observers are typically handled by a predefined protocol (e.g., averaging, or a third observer if differences are significant), but these specifics are not mentioned in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is not relevant for a standalone blood pressure monitor. The device itself performs the measurement; it does not assist human readers in interpreting complex imagery or clinical data in the way an AI algorithm might.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance assessment was effectively done. The clinical validation conducted according to ISO 81060-2 assesses the device's accuracy in measuring blood pressure independently, without human interpretation other than setting up the device and initiating the measurement. The device's measurement algorithm is evaluated directly against a reference standard.

7. The Type of Ground Truth Used

• Expert Consensus (Auscultation): For blood pressure monitor validation per ISO 81060-2, the ground truth for blood pressure measurements is established through simultaneous or closely timed readings by trained human observers using the auscultatory method (stethoscope and sphygmomanometer/mercury manometer), which is considered the clinical reference standard.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided: The summary indicates that the subject device (BP3T01-1B) uses the "same oscillometric method" and "common blood pressure measurement technological architecture and algorithm" as the predicate device (BP3KV1-5K). It does not describe a new algorithm that required a specific training set. Blood pressure algorithms for oscillometric devices are typically developed based on physiological models and empirical data, rather than being "trained" in the machine learning sense with a discrete "training set" in the context described here. If iterative development was done, the size of data used for such development is not provided.

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

• Not Applicable / Not Provided: As in point 8, the concept of a "training set" with established ground truth as it applies to machine learning models is not explicitly relevant or described for this blood pressure monitor's algorithm development in the provided documentation. The algorithm's fundamental principles are stated to be the same as the predicate device, implying established and verified methods rather than a newly trained model requiring specific ground truth for training.

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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 Upper Arm Blood Pressure Monitor, Model BP3KV1-5W 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 22 to 52cm.

The device is suitable for use by adults with conditions of diabetes, pregnancy, or pre-eclampsia.

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 BP3KV1-5W is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 22 -52 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 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 after the measurement. In addition, 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.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that a clinical study was conducted using the BP3KT1-3N (European Device) for validation. This study was a "prospective, open-label, non-randomized, single-center validation study." The study followed the ANSI/AAMI/ISO 81060-2:2019 test standard.

While the exact sample size for the test set is not explicitly stated in the provided text, the ANSI/AAMI/ISO 81060-2:2019 standard typically requires a minimum of 85 subjects for validation of blood pressure devices (as referenced in the acceptance criteria regarding absolute differences).

The data provenance is prospective, single-center, and from a European Device (BP3KT1-3N). The specific country is not mentioned beyond "European Device."

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 or their qualifications for establishing the ground truth. However, for a clinical validation study following the ANSI/AAMI/ISO 81060-2:2019 standard, the ground truth for blood pressure measurements is typically established by at least two trained observers (experts) using a mercury sphygmomanometer or an equivalent reference device, meticulously following standardized auscultatory procedures. These observers are usually trained and certified in blood pressure measurement techniques.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method. In clinical validation studies conforming to the ANSI/AAMI/ISO 81060-2 standard, when multiple observers are used for ground truth, a common adjudication method involves taking the average of the observers' readings, or in cases of significant discrepancy, a third observer might be used to mediate or resolve differences. The standard itself outlines specific requirements for how observer readings should be handled.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. The provided information describes a clinical validation study for the device's accuracy against a reference standard, not a study comparing human reader performance with and without AI assistance.

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

Yes, a standalone performance study was done for the blood pressure measurement component. The clinical study for the BP3KT1-3N device validated its accuracy according to the ANSI/AAMI/ISO 81060-2:2019 standard. This standard assesses the device's ability to accurately measure blood pressure on its own, without direct human interpretation or modification of the measurement itself during the process (though a human activates the device and applies the cuff). The study concluded that "The Microlife device has passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 test standard," which is a testament to its standalone measurement accuracy.

7. The Type of Ground Truth Used

The ground truth used for the clinical validation study was auscultatory measurement (reference sphygmomanometry). This is implied by the ANSI/AAMI/ISO 81060-2:2019 standard which compares the automated device's readings against a series of auscultatory measurements by trained observers.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. The clinical study mentioned is a validation study, which typically involves a separate set of subjects from any training data used for algorithm development.

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

The document does not provide information on how the ground truth for the training set was established, as details about the training process and data are not included.

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor,Model WatchBP O3 (BP3SZ1-1) is a non-invasive 24 hour ambulatory blood pressure monitor (ABPM) using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for or use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm.

The device can accurately measure in pregnant patients including those with known or suspected preeclampsia.

The device provides aortic blood pressure parameters, includes central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff.

The device detects the appearance of atrial fibrillation during measurement and gives a warning signal together with the measured blood pressure value if atrial fibrillation is detected.

The memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth.

The device is intended to be used by healthcare professionals and patient's environments.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP O3 (BP3SZ1-1) is designed to measure systolic and diastolic blood pressure, pulse rate, and mean arterial pressure (MAP) of the adults and pediatrics (but not neonates) populations with arm circumference sizes ranging from 14 -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 use a resistive pressure sensor rather than a stethoscope and mercury manometer. The sensor 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, mean arterial pressure (MAP), central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic pressure (cDBP) which is a well - known technique in the market called the "oscillometric method".

The device is a 24 hour ambulatory blood pressure monitor (ABPM) .It's selected for fully programmable 24-hour patient out-of-office blood pressure measurement, the device automatically takes measurements at fixed intervals programmed by the physician.

The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.

The device detects the appearance of atrial fibrillation during measurement and the atrial fibrillation symbol "is displayed on the LCD screen if any atrial fibrillation signal has been detected.

In addition, the memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth.

The device is intended to be used by healthcare professionals and patients in clinical and patient's environments.

The medical device referenced is the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP O3 (BP3SZ1-1).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood pressure monitors generally follow established standards such as ISO 81060-2. While the exact numerical criteria aren't explicitly stated in a table format within the provided document, the text mentions compliance with ISO 81060-2:2018 for clinical validation. This standard outlines the accuracy requirements for intermittent automated measurement types of non-invasive sphygmomanometers.

Reported Device Performance:
The document states that the clinical validation reports for the subject device, following ISO 81060-2:2018, demonstrate the accuracy of blood pressure measurement in the general population across a wide range of arm sizes and for ambulatory blood pressure monitoring (VOL 10, 002 and VOL 10, 003).

Additional performance features and claims for which the device's accuracy is asserted (by leveraging predicate device validation or by implication of compliance with standards) include:

• Accurate measurement in pregnant patients, including those with known or suspected pre-eclampsia.
• Detection of atrial fibrillation.
• Measurement of aortic blood pressure parameters (cSBP, cPP, cDBP).

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

The document does not explicitly state the numerical sample size for the clinical test sets. It refers to "clinical validation reports of the subject device following ISO 81060-2:2018 for use in general population across a wide range of arm sizes (VOL 10, 002) and intended for ambulatory blood pressure monitoring (VOL 10, 003)".

The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.

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

This information is not provided in the given text. For non-invasive blood pressure monitors, the ground truth for accuracy studies is typically established by trained observers taking auscultatory measurements using a mercury sphygmomanometer, not usually by "experts" in the sense of physicians establishing diagnoses. The methodology of ISO 81060-2:2018 would dictate the number and training of these observers.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly mentioned. For blood pressure measurement validation studies, ground truth is typically established by simultaneous measurements or sequential measurements by multiple trained observers, with specified acceptable differences between their readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable and was not conducted as this is a device for automated measurement of blood pressure, not an imaging or diagnostic AI system requiring human reader interpretation. Thus, the concept of "how much human readers improve with AI vs without AI assistance" does not apply here.

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

Yes, the primary clinical validation conducted falls under a standalone performance evaluation. The device is an "Automatic Digital Blood Pressure Monitor" using an "oscillometric technique." The clinical validation according to ISO 81060-2:2018 assesses the accuracy of the device's automated measurements against a reference standard (typically auscultatory measurements). This evaluates the algorithm's performance directly, as it automatically determines systolic and diastolic blood pressure, pulse rate, MAP, cSBP, cPP, cDBP, and atrial fibrillation detection.

7. The Type of Ground Truth Used

For the blood pressure measurement accuracy (ISO 81060-2:2018), the ground truth is established by a reference standard measurement, typically simultaneous auscultatory measurements performed by trained observers using a mercury sphygmomanometer or equivalent, as per the standard's protocol.

For the atrial fibrillation detection, the ground truth would likely be established by a reference ECG recording interpreted by a cardiologist, although this specific detail is not provided.

8. The Sample Size for the Training Set

The document describes this as a premarket notification for a predicate device. It explicitly states that the subject device (BP3SZ1-1) uses "the same software algorithm to determine the systolic and diastolic blood pressure, pulse rate, mean arterial pressure (MAP), central systolic blood pressure (cSBP) and central diastolic pressure (cDBP), central pulse pressure (cPP) and Atrial Fibrillation Detection" as the predicate device (BP3SK1-3B). This indicates the algorithm was already developed and validated with prior data, likely from the predicate device's development or other studies that are not mentioned in this submission.

Therefore, the sample size for a "training set" for the algorithm itself is not provided in this document, as the focus is on clinical validation of the device using an existing algorithm.

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

As stated above, the document doesn't provide information on the training set for the algorithm. However, given that the algorithm is the "same" as a predicate device, its original ground truth would have been established through a similar process of comparing automated blood pressure readings against reference standard auscultatory measurements (for blood pressure) and likely expert-adjudicated ECGs (for AFib detection) during its development and initial validation.

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual with arm cuff circumference sizes ranging from 22 -42 cm by using a non-invasive oscillometric technique in one inflatable cuff being wrapped around the upper arm.

The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.

The memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer Home 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 device is intended for use by patient at home or by health care givers in primary care settings.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C) is designed to measure systolic and diastolic blood pressure and pulse rate of an adult 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 a resistive 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 has > and > measurement modes. The > mode is selected for a regular single measurement. The > mode is selected for diagnosis or follow-up.

The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected. If atrial fibrillation is detected during all readings of the triple measurements in usual mode or all four readings of one day in diagnostic mode, the Afib icon is displayed.

In addition, the memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer Home 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 device is intended for use by patient at home or by health care givers in primary care settings.

The provided text is a 510(k) Summary for a medical device, the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C). This summary focuses on establishing substantial equivalence to a predicate device, the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home N (BP3MX1-4) (K100763).

The document does not contain a new study that proves the device meets specific acceptance criteria based on independent clinical data for the subject device (BP3MX1-3C). Instead, it leverages the clinical validation of the predicate device (BP3MX1-4) to argue for substantial equivalence.

Therefore, for the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" for the subject device (BP3MX1-3C), the answer is that a new clinical study was not performed to independently prove the subject device's performance against specific acceptance criteria.

The document explicitly states:

"From a clinical validation standpoint, the subject device is identical to the 510(k) cleared predicate device, WatchBP Home N (BP3MX1-4), K100763, in blood pressure measurement and atrial fibrillation detection."
"Therefore the performance of the WatchBP Home A BT (BP3MX1-3C) in terms of blood pressure measurement and atrial fibrillation detection would be essential equivalent with performance of the predicate device WatchBP Home N (BP3MX1-4). There was no repeated clinical testing required for blood pressure measurement and atrial fibrillation detection to support WatchBP Home A BT (BP3MX1-3C) as the subject device can leverage the clinical validation of WatchBP Home N (BP3MX1-4) that was proven in K100763."

Given this, it is not possible to provide the requested details for the subject device's independent clinical study as it was asserted that such a study was not warranted due to substantial equivalence to the predicate.

Information that CANNOT be Extracted from the Provided Text:

• A table of acceptance criteria and the reported device performance for the subject device's own clinical study: No such study was reported for the subject device.
• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) for the subject device's own clinical study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience) for the subject device's own clinical study.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set for the subject device's own clinical study.
• If a multi reader multi case (MRMC) comparative effectiveness study was done for the subject device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done for the subject device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the subject device's own clinical study.
• The sample size for the training set for the subject device’s algorithm (if applicable).
• How the ground truth for the training set was established for the subject device’s algorithm (if applicable).

Information that MAY be Inferred or Found in the Referenced Predicate Device (K100763):

The document states that the predicate device (WatchBP Home N, K100763) had its clinical validation for blood pressure measurement and atrial fibrillation detection proven. Therefore, the requested information (acceptance criteria, study details, ground truth, etc.) would likely be found in the 510(k) submission for K100763. The current document only refers to that previous clearance.

The only "acceptance criteria" presented are the non-clinical tests performed to demonstrate safety and effectiveness, based on recognized international standards. These are not clinical acceptance criteria for performance in measuring blood pressure or detecting AFib.

Non-Clinical Testing Standards (from section 7):

The device underwent non-clinical testing according to the following standards, demonstrating it met the requirements of these standards:

• IEC 60601-1 / AAMI / ANSI ES60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R) 2012 And A2:2010/(R) 2012 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance)
• IEC 60601-1-2:2014 (Electromagnetic Disturbances - Requirements And Tests)
• ISO 14971: 2007 (Medical devices Application of risk management)
• AAMI/ANSI/ISO 10993-1:2009/(R)2013, -5:2009/(R)2014, -10:2010/(R)2014 (Biological evaluation of medical devices)
• AAMI/ANSI/IEC 80601-2-30: 2013 (Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers)
• IEC 60601-1-11:2015 (Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment)
• AAMI/ANSI /ISO 81060-2: 2013 (Non-Invasive Sphygmomanometers Part 2: Clinical Validation of Automated Measurement Type) - This standard is the relevant one for clinical performance, but the document states that the subject device leveraged the predicate's validation for this, rather than performing a new one.

In summary, the provided text does not contain a report of a new clinical study for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C) to prove its performance against acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a previously cleared device (K100763) which had already undergone such clinical validation.

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor,Model WatchBP Office (BP3SK1-3B) is a noninvasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm.

The device can accurately measure in pregnant patients including those with known or suspected preeclampsia.

The device provides aortic blood pressure parameters. includes central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff.

The device detects the appearance of atrial fibrillation during measurement and gives a warning signal together with the measured blood pressure value if atrial fibrillation is detected.

The memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth.

The device is for hospital use only.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (BP3SK1-3B) is designed to measure systolic and diastolic blood pressure, pulse rate, and mean arterial pressure (MAP) of the adults and pediatrics (but not neonates) populations with arm circumference sizes ranging from 14 -52 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 a resistive pressure sensor rather than a stethoscope and mercury manometer. The sensor 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, mean arterial pressure (MAP), central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic pressure (cDBP) which is a well - known technique in the market called the "oscillometric method".

The device has two measurement modes that can be used :> mode and > mode. It has number of measurements setting function, resting time setting function, measurement intervals setting function, atrial fibrillation detection function, Central Blood Pressure (CBP) measurement function etc. In addition, the device can be used in connection with your personal computer (PC) running the WatchBP Analyzer software. The memory data can be transferred to the PC by connecting the monitor with the PC via USB cable or Bluetooth.

The measurement program in > mode of the device can be set, includes Number of Measurements, Resting Time (Countdown time), Interval Time, AFIB detector, CBP measurement, HIDE and Average calculation (Discard 1st measurement). Select > mode, press the Ubutton to perform automatic measurements based on the settings of > mode. The device shows all the settings and then starts counting down the Resting Time before the first measurement. The average measurement reading is displayed and saved after the measurements are complete.

The measurement program in > mode can be set to preferences. The program includes setting the Highest Cuff Pressure and Hide Cuff Pressure during deflation. Select the >mode if auscultatory blood pressure measurement is preferred above oscillometric blood pressure measurement. In > mode, the device serves as a pressure gauge. No oscillometric measurements will be taken. Systolic and diastolic Korotkoff sounds are determined by the physician using a stethoscope placed over the brachial artery.

The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.

The device detects the appearance of atrial fibrillation during measurement and the atrial fibrillation symbol "is displayed on the LCD screen if any atrial fibrillation signal has been detected.

The device is for hospital use only.

This document is a 510(k) summary for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (BP3SK1-3B).

The information provided does not contain specific acceptance criteria or detailed study results for the device itself. Instead, it focuses on demonstrating substantial equivalence to two predicate devices (ProBP 2400 and WatchBP Office Central (TWIN200 CBP)) by explaining that the new device shares the same fundamental scientific technology and algorithms for blood pressure measurement, AFIB detection, and central blood pressure measurement.

The document claims that no repeated clinical testing was required for the subject device because it leverages the clinical validation of the predicate devices. Therefore, it does not provide original acceptance criteria or study data for the Model WatchBP Office (BP3SK1-3B).

However, it does mention that the predicate device ProBP 2400 was proven in K152770 and the predicate device WatchBP Office Central (TWIN200 CBP) was proven in K171937, implying that these earlier submissions would contain the clinical study data and acceptance criteria for those devices, which the current device is deemed equivalent to.

Based on the provided text, I cannot complete the requested tables and information directly for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (BP3SK1-3B) as it does not present its own clinical study results or acceptance criteria.

The document explicitly states:

• "Repeat clinical testing in accordance with the standard AAMI / ANSI/ISO81060-2 for the subject device WatchBP Office (BP3SK1-3B) regarding brachial blood pressure measurement in pregnant patients including those with known or suspected preeclampsia, adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm is therefore not necessary."
• "There was no repeated clinical testing required for brachial blood pressure, AFIB detection and CBP&CPP measurement to support WatchBP Office as the subject device WatchBP Office (BP3SK1-3B) can leverage the clinical validation of WatchBP Office Central (TWIN200 CBP) that was proven in K171937.Repeat clinical testinq in accordance with the standard AAMI / ANSI/IEC81060-2 for the subject device WatchBP Office (BP3SK1-3B) regarding brachial blood pressure measurement, AFIB detection and CBP&CPP measurement for use in adults is therefore not necessary."

To answer your request thoroughly, one would need access to the 510(k) submissions K152770 and K171937 for the predicate devices, which would contain the original clinical study data and acceptance criteria.

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GY1-2N 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 in which an inflatable cuff is being wrapped around the upper arm.

The device is also validated for all adult diabetic users.

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 running the APP. The memory data can be transferred to the smart phone via Bluetooth.

The blood pressure monitor is a fully automatic digital blood presure measuring device for use by adults (also applicable for diabetic patients) on the upper arm at home or in your doctor's/nurse's office.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GY1-2N 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 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 after the measurement. In addition, the device can be used in connection with smart mobile devices running the APP and via Bluetooth.

The device is also validated for all adult diabetic users.

The blood pressure monitor is a fully automatic digital blood pressure measuring device for use by adults(also applicable to the diabetic patients) on the upper arm at home or in your doctor's/nurse's office.

Here's an analysis of the acceptance criteria and study information for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GY1-2N, based on the provided text:

Important Note: The provided document is a 510(k) summary for a new device (BP3GY1-2N) claiming substantial equivalence to a predicate device (BP3GX1-5X). Therefore, the "study that proves the device meets the acceptance criteria" refers to the predicate device's clinical validation study, which the subject device is leveraging. The new device itself did not undergo a separate clinical validation study for blood pressure accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for blood pressure monitors is typically defined by standards like ANSI/AAMI/IEC 81060-2. While the exact numerical criteria are not explicitly stated in this document (they would be detailed in the standard itself), it is generally understood to involve accuracy metrics for systolic and diastolic blood pressure measurements compared to a reference method.

The document indicates that the device's performance is demonstrated by its substantial equivalence to a clinically validated predicate device.

• Mean difference (device vs. reference) and standard deviation for systolic and diastolic BP
• Within-subject differences (e.g., % of readings within 5 mmHg) | The subject device (BP3GY1-2N) is technically identical to the primary predicate device (BP3GX1-5X, K183469) concerning detection algorithm and fundamental scientific technology. The predicate device was clinically validated according to ANSI/AAMI/IEC 81060-2 and proved accurate for blood pressure detection. Also validated for adult diabetic users. |
  | Irregular Heartbeat Detection: | Detects and signals irregular heartbeat during measurement. |
  | Functional / Safety Standards Compliance: | Complies with numerous IEC, ISO, and AAMI standards for electrical safety, EMC, risk management, biocompatibility, and home healthcare environments (listed in section 7). |

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

• Sample Size: Not explicitly stated in this document for the predicate device's clinical study. The document refers to the predicate's 510(k) (K183469) where this information would be found. Standards like ANSI/AAMI/IEC 81060-2 require specific sample sizes (e.g., at least 85 subjects).
• Data Provenance: Not specified in the provided text. The location of the original clinical validation study for the predicate device is not mentioned.
• Retrospective or Prospective: Not specified in the provided text for the predicate device's clinical study.

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

• Number of Experts: Not explicitly stated. For clinical validation of blood pressure devices based on standards like ANSI/AAMI/IEC 81060-2, multiple qualified observers (e.g., physicians or specially trained technicians) are typically used for the auscultatory reference measurements.
• Qualifications of Experts: Not explicitly stated in this document. However, standard clinical validation protocols require observers to be trained and certified in auscultatory blood pressure measurement.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. In auscultatory reference measurements, it is common to have multiple observers taking measurements simultaneously, and their readings are often averaged or assessed for agreement. The specific method would be detailed in the predicate device's clinical study report.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, an MRMC comparative effectiveness study for human readers with and without AI assistance was not conducted. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic imaging device that would typically involve human readers interpreting cases.
• Effect size of human readers improved with AI vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Yes. The clinical validation of the predicate device (BP3GX1-5X) against the ANSI/AAMI/IEC 81060-2 standard represents a standalone performance study. This standard assesses the accuracy of the automated device (algorithm only) compared to a reference standard (auscultation), without human interpretation of the device's output influencing the measurement itself. The subject device BP3GY1-2N is leveraging this standalone clinical data from the predicate.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for blood pressure accuracy in studies following ANSI/AAMI/IEC 81060-2 is established using auscultatory measurements performed by trained human observers using a stethoscope and manometer. This is considered the clinical reference standard for non-invasive blood pressure.

8. Sample Size for the Training Set

• Sample Size for Training Set: This information is not provided in the document. For a medical device like this, the "training set" typically refers to the data used to develop and refine the oscillometric algorithm. This data is usually proprietary to the manufacturer and not typically disclosed in 510(k) summaries unless specifically required for algorithm-based devices where the training data directly impacts performance claims.

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

• How Ground Truth for Training Set Was Established: This information is not provided in the document. Similar to the sample size, the process for establishing ground truth for the internal development and training of the oscillometric algorithm is generally proprietary. It would likely involve similar auscultatory reference measurements to those used in the final clinical validation, but potentially in a more controlled or varied dataset for algorithm optimization.

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GX1-5X (BP A3 PC) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual of 12 years and older, with arm circumference sizes ranging from 22 -52 cm by using a non-invasive oscillometric technique in an inflatable cuff being wrapped around the upper arm.

The device is also validated for patients with diabetes mellitus in the age 56 years and older.

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 PC.

The blood pressure monitor is a fully automatic digital blood pressure measuring device for use by adults (also applicable for diabetic patients) on the upper arm at home or in your doctor's/nurse's office.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GX1-5X (BP A3 PC) is designed to measure systolic and diastolic blood pressure, pulse rate of an adult individual with arm circumference sizes ranging from 22 -52 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 is also validated for patients with diabetes mellitus.

The blood pressure monitor is a fully automatic digital blood pressure measuring device for use by adults (also applicable to the diabetic patients) on the upper arm at home or in your doctor's/nurse's office.

The provided text is a 510(k) Pre-market Notification for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GX1-5X (BP A3 PC). The document primarily focuses on establishing substantial equivalence to a predicate device (Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GT1-6X) rather than detailing a specific de novo study for the device's acceptance criteria and performance against those criteria.

However, it does mention a clinical trial specifically for diabetic patients to validate the device's performance according to ANSI/AAMI IEC 81060-2. This is the part of the submission that touches upon acceptance criteria and study data.

Let's break down what can be extracted based on your request, and where information is missing or not explicitly stated in this document.

Acceptance Criteria and Device Performance for Diabetic Patients

The document states: "The clinical performance according to ANSI/AAMI IEC 81060-2 of BP3GX1-5X (BP A3 PC) for the diabetic adults was evaluated in a clinical trial (please see VOL 10, 002)."

The ANSI/AAMI IEC 81060-2 standard specifies the clinical validation requirements for automated non-invasive sphygmomanometers. While the specific acceptance criteria and performance results (e.g., mean difference and standard deviation between device and reference measurements) are not directly listed in this document, they would be defined by this standard.

Based on the nature of a 510(k) submission, the implicit "acceptance criteria" here are that the study results demonstrate compliance with the accuracy requirements of ANSI/AAMI IEC 81060-2 for blood pressure monitors.

Implicit Acceptance Criteria (from ANSI/AAMI IEC 81060-2, generally):

For each pressure (systolic and diastolic):

• Criterion 1: Mean difference between the device measurement and reference measurement (Hg equivalent) should be less than or equal to ±5 mmHg.
• Criterion 2: Standard deviation of the differences should be less than or equal to 8 mmHg.

The document does not report the specific achieved performance values (mean difference, std. dev.) against these criteria. It only states that the device was "evaluated in a clinical trial" and implies that it passed, enabling clearance.

Study Details (Specifically for Diabetic Patients Validation):

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and reported device performance:

   Criterion (Implied from ANSI/AAMI IEC 81060-2)	Acceptance Criteria for Systolic/Diastolic BP (mmHg)	Reported Device Performance (Systolic/Diastolic BP) (mmHg)
   Mean difference from reference	≤ ±5	Not explicitly reported in this document.
   Standard deviation of differences	≤ 8	Not explicitly reported in this document.

   Note: The document confirms compliance with the standard but does not provide the specific numerical results of the clinical trial for diabetic patients.

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

   • Sample Size: Not explicitly stated in this document. The ANSI/AAMI IEC 81060-2 standard typically requires a minimum of 85 subjects for clinical validation.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "patients with diabetes mellitus in the age 56 years and older." The study appears to be prospective as it's a clinical trial for validation.

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

   • For blood pressure monitor validation using ANSI/AAMI IEC 81060-2, ground truth is typically established by two trained observers (experts) using a auscultatory method with a mercury sphygmomanometer or equivalent, blinded to each other's readings, and to the automated device's readings.
   • Qualifications: "Trained observers" are generally required, implying specific training in standard blood pressure measurement techniques. Specific qualifications (e.g., "physician with X years of experience") are not detailed here, but are standard for such trials.

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

   • For ANSI/AAMI IEC 81060-2, if the two observers' readings differ by more than a specified amount (e.g., 4 mmHg), a third independent observer (2+1 method) is typically used for adjudication or the measurement is discarded. This specific detail is not explicitly stated but is a standard practice for compliance with this standard.

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. This is a validation study for an automated blood pressure monitor, not a diagnostic imaging AI system involving human readers. Therefore, an MRMC study is not applicable here.

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

   • Yes, the core validation for blood pressure accuracy (the "standalone" performance of the device) was done against reference measurements taken concurrently by human observers. The device itself is an automated system without constant human intervention during the measurement process.

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

   • The ground truth for blood pressure measurement is established through concurrent auscultatory measurements by trained human observers using a validated reference method (e.g., mercury sphygmomanometer), as per the ANSI/AAMI IEC 81060-2 standard. This is a form of expert reference standard.

8. The sample size for the training set:

   • This device is not an AI/machine learning model in the sense that it requires a "training set" to learn how to measure blood pressure. Its algorithm is fixed. Therefore, this question is not applicable. The device uses an "oscillometric method" with a defined algorithm.

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

   • As stated above, this question is not applicable as there is no training set in the context of an adaptive AI model. The device's algorithm for determining systolic and diastolic pressure is described as one that "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 algorithm itself is pre-programmed, not learned from data in the field.

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office Central (TWIN200 CBP) is a device intended to measure the systolic and diastolic blood pressure, pulse rate, Mean Arterial Pressure (MAP), anklearm blood pressure and calculates Pulse Pressure (PP) and Ankle Brachial Index (ABI) of an adult individual with arm circumference sizes ranging from 22-42 cm and ankle circumference sizes ranging from 22-32 cm. It uses a non-invasive oscillometric technique using one (single arm) or two (dual arm measurement) inflatable cuffs wrapped around the upper arms and one inflatable cuff wrapped around the ankle (ABI).

The device provides aortic blood pressure parameters. includes central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic pressure (cDBP), non-invasively through the use of a brachial cuff.

The device detects the appearance of atrial fibrillation during measurement and gives a warning signal together with the measured blood pressure value if atrial fibrillation is detected.

The device can be connected to a personal computer (PC) running the WatchBP Analyzer Office software. The measured patient data can be transferred from the blood pressure monitor to the PC by means of a USB cable connection.

The blood pressure monitor is an automated digital professional clinical device for measuring blood pressure in upper arm and ankle in adults.

The device is for hospital use only.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office Central (TWIN200 CBP) is designed to measure systolic and diastolic blood pressure, pulse rate and calculate Pulse Pressure (PP), Mean Arterial Pressure (MAP),Ankle Brachial Index (ABI), Central Blood Pressure(CBP) and Central Pulse Pressure(CPP) of an adult individual with arm circumference sizes ranging from 22 -42 cm a (rigid cuff for central BP and a soft cuff for brachial BP measurements) and ankle circumference sizes ranging from 22 -32 cm (using a soft cuff) by using a non-invasive technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s) and one inflatable cuff is wrapped around the ankle. 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, Pulse Pressure (PP), Mean Arterial Pressure (MAP),Ankle Brachial Index (ABI) Central Blood Pressure(CBP) and Central Pulse Pressure(CPP) which is a well known technique in the market called the "oscillometric method".

The device has >, > and > measurement modes and has atrial fibrillation detection function, inflation pressure setting function, measurement intervals setting function etc. In addition, the device can be used in connection with your personal computer (PC) running the WatchBP Analyzer Office software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable.

The > mode is selected to complete a fully-automated triple measurements on both arms according to recommended ESH/AHA blood pressure measurement protocols for a patient's first office visit.

The > mode is selected to perform central blood pressure measurements on the preferred arm for prompt and accurate office measurements.

The > mode is selected for Ankle Brachial Index pressure measurement. Select the lateral with the higher blood pressure value according to the measurement result of > mode.

The device detects the appearance of atrial fibrillation during measurement and the atrial fibrillation symbol "is displayed on the LCD screen if any atrial fibrillation signal has been detected.

The blood pressure monitor is an automated digital professional clinical device for measuring blood pressure in upper arm and ankle in adults

The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office Central (TWIN200 CBP), demonstrates substantial equivalence to its predicate devices through non-clinical and clinical testing.

Here's an analysis of the provided text, broken down by your requested categories:

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

The provided text doesn't explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance." However, it does refer to compliance with various standards, which implicitly set the acceptance criteria. The device's performance is affirmed by its clinical validation and demonstration of substantial equivalence.

Based on the information, the primary performance criteria are related to accuracy of blood pressure measurement and detection of Atrial Fibrillation (AFIB) and Ankle Brachial Index (ABI).

Study Details:

The document describes a clinical study that was used to validate the performance of the device, particularly regarding its brachial blood pressure measurement with the new cuff and its ability to estimate central blood pressure.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to a published clinical study by Cheng et al. titled "Measurement Accuracy of a Stand-Alone Oscillometric Central Blood Pressure Monitor: A Validation Report for Central Microlife WatchBP Office Central." However, it does not specify the sample size used in this study. It also does not explicitly state the country of origin or whether it was retrospective or prospective. Given the nature of a validation report for accuracy, it is highly likely to be a prospective study.

For the brachial blood pressure measurement, AFIB detection, and ABI detection, the device leverages the clinical validation of the predicate device (WatchBP Office ABI, K112845). The specifics of the original predicate validation study (including sample size, provenance, etc.) are not detailed in this 510(k) summary.

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

For the validation of brachial systolic and diastolic blood pressure, the standard AAMI / ANSI / ISO 81060-2 dictates specific requirements for the ground truth, typically involving multiple trained observers (experts) using auscultation with a mercury manometer or equivalent standardized reference. The document states that the Cheng et al. study confirmed performance "against auscultation reference measurement," implying that such experts were used. However, the exact number of experts and their specific qualifications are not provided in this document.

For Central Blood Pressure (CBP) parameters, the document states "The efficacy of the use of the rigid conical cuff was proven clinically," likely through the same study. The ground truth for central blood pressure validation typically involves invasive radial artery catheterization and tonometry, or a previously validated non-invasive method often requiring comparison with invasive measurements. The document does not specify the method or the experts involved for CBP ground truth.

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

The document does not explicitly state the adjudication method used in the Cheng et al. study for establishing the ground truth, especially for brachial blood pressure measurements. Standard ISO 81060-2 protocols often involve two observers, with a third observer called upon in case of discrepancies, but this is not confirmed here.

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 done, and this device is not an AI-assisted diagnostic tool for human readers. This device is an automated blood pressure monitor. The evaluation focuses on the device's standalone accuracy against reference methods, not on how it assists human interpretation of images or other data.

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 automated system designed to measure blood pressure, pulse rate, MAP, ABI, and CBP, and detect AFIB. The clinical study (Cheng et al.) directly assesses the accuracy of the device's measurements against reference methods, which is a standalone performance evaluation. The statement "Measurement Accuracy of a Stand-Alone Oscillometric Central Blood Pressure Monitor" directly supports this.

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

• For Brachial Blood Pressure (Systolic and Diastolic): Auscultation reference measurement is stated as the ground truth, which relies on expert observers (human experts) listening to Korotkoff sounds. This falls under a form of "expert consensus/reference standard."
• For Atrial Fibrillation (AFIB) Detection and Ankle Brachial Index (ABI): The device leverages the validation of the predicate device (K112845). While not explicitly stated here, the ground truth for these would typically involve comparison to an ECG for AFIB and Doppler assessment for ABI, overseen by medical professionals.
• For Central Blood Pressure (CBP) Parameters: The document states the efficacy was "proven clinically," but does not specify the ground truth method. For CBP, this typically involves invasive catheterization or a validated non-invasive method that itself was validated against invasive measurements.

8. The sample size for the training set

The document does not provide information on the sample size used for the training set of the device's algorithms. As the core algorithms for brachial BP, AFIB, and ABI are inherited from a predicate device, their "training" would have occurred with the predicate device's development. For the CBP estimation, if it involves a model trained on data distinct from the predicate's main algorithm, the training set size is not disclosed.

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

The document does not provide information on how the ground truth for any potential training set was established. Since the device leverages an existing oscillometric algorithm from a predicate device, its fundamental "training" would likely have been established during the development and validation of that earlier device. For the novel CBP functionality, if a machine learning model was used, the method for establishing ground truth for its training data is not mentioned. Typically, this would involve paired measurements (e.g., non-invasive device reading vs. invasive central arterial pressure).

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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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