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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 BP3MS1-3B 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 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 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 an automatic digital blood pressure measuring device for use by adults on the upper arm at home or in your doctor's/nurse's office.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-3B 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 device can be used in connection with smart mobile devices running the APP. The memory data can be transferred to the smart mobile devices via Bluetooth.

The blood pressure monitor is an automatic digital blood pressure measuring device for use by adults on the upper arm at home or in your doctor's/nurse's office.

This document is a 510(k) premarket notification for a blood pressure monitor, not a study evaluating a new AI/ML-driven device. Therefore, it does not contain the information requested in points 1-9, which are typically associated with the rigorous testing and validation of AI/ML systems, particularly in medical imaging or diagnostic contexts.

Specifically:

• No AI/ML Component: The device described, the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-3B, is a traditional oscillometric blood pressure monitor. It uses established techniques for blood pressure measurement and irregular heartbeat detection. There is no indication of an AI or machine learning algorithm being used for diagnosis, image analysis, or complex pattern recognition as would be relevant for the requested criteria.

• Clinical Testing for BP Monitors: The "Discussion of Clinical Tests Performed" (Section 8) explicitly states that repeated clinical testing for the subject device (BP3MS1-3B) was not necessary because its technical and algorithmic aspects are identical to a previously cleared predicate device (BP3MS1-4A). The clinical performance of this type of device is typically validated against a standard like ANSI/AAMI IEC81060-2, which focuses on accuracy compared to a reference method, not against complex diagnostic criteria or human reader performance.

• Scope of 510(k) Submission: A 510(k) submission primarily aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove novel clinical efficacy or superiority through comparative studies like MRMC.

Therefore, I cannot provide the requested information based on the provided text. The document describes a traditional medical device and its regulatory clearance process, not the validation of an AI/ML-driven diagnostic or assistive system.

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The Microlife Upper Arm Automatic Dizital Blood Pressure Monitor. Model BP3MW1-4B is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual by using a non-invasive oscillometric technique in one inflatable cuff is wrapped around the single upper arm.

The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.

This device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.

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 for use by adults on the upper arm at home.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW 1-4B is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method". This device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia.

The device detects the appearance of irreqular heartbeat during measurement. and the symbol " 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 provided text is a 510(k) Summary for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4B. It primarily describes how the new device is substantially equivalent to previously cleared predicate devices. While it mentions clinical validation and standards, it explicitly states that new clinical testing for the subject device was not performed because it is technically identical to a predicate device regarding the measurement algorithm and program codes. Therefore, the details requested about acceptance criteria and a new study done to prove the device meets these criteria are largely absent for this specific device model.

However, I can extract information related to the predicate device's clinical validation as that is what the new device is inheriting its performance claims from.

Here's a breakdown of the available information based on your requested points:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria and reported device performance for the specific device in question (BP3MW1-4B). It states that the device's performance is identical to its predicate device, BP3MW1-4X(R), due to identical technical specifications, measurement algorithm, and program codes.

Therefore, the acceptance criteria and performance would be those established for the predicate device, which would have been validated against standards such as ANSI/AAMI IEC81060-2: "Non-invasive sphygmomanometers – Part 2: Clinical validation of automated measurement type." This standard sets criteria for accuracy in blood pressure measurements.

Based on the reference to ANSI/AAMI IEC81060-2 in the text, typical acceptance criteria for blood pressure monitors would involve:

• Mean Difference (Bias): The average difference between the device's readings and reference measurements (e.g., auscultatory readings).
• Standard Deviation (Precision): The variability of the device's readings compared to reference measurements.
• Number of readings within certain absolute differences: For example, how many readings are within ±5 mmHg, ±10 mmHg, etc.

As the document explicitly states "Repeat clinical testing in accordance with the standard ANSI/AAMI IEC81060-2 for the subject device BP3MW1-4B is therefore not necessary," it does not provide a new table of acceptance criteria and reported performance for this specific model.

Study Information (Inherited from Predicate Device)

Given that the clinical performance is inherited from the predicate device BP3MW1-4X(R), the following points relate to the type of study that would have been performed for that predicate device to meet the ANSI/AAMI IEC81060-2 standard, which is referenced. The document for K153077 does not provide the specific details for that predicate device's study.

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

   • Sample Size: Not specified in this 510(k) summary for the predicate device's clinical validation. The ANSI/AAMI IEC81060-2 standard typically requires a minimum of 85 participants for clinical validation.
   • Data Provenance: Not specified. Clinical validation studies for such devices are typically prospective, conducted in a clinical setting.

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

   • Number of Experts: Not specified. For blood pressure monitor validation studies (e.g., against ANSI/AAMI IEC81060-2), at least two trained observers (e.g., physicians or nurses) are typically used for reference auscultatory measurements.
   • Qualifications: "Trained observers" who are specifically skilled in auscultatory blood pressure measurement.

3. Adjudication method for the test set:

   • Adjudication Method: Not explicitly stated. In blood pressure validation studies using multiple observers, differences between the observers' readings are typically handled by averaging the readings if they are within a specified tolerance, or by discarding the measurement if they are outside a tolerance, or by having a third observer adjudicate.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done:

   • MRMC Study: No. This type of study (MRMC) is generally for diagnostic imaging devices assessing reader performance. Blood pressure monitor validation primarily focuses on the device's accuracy in comparison to a reference standard, not on human reader improvement with AI assistance.

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

   • Standalone Performance: Yes, the clinical validation is a standalone performance assessment of the oscillometric algorithm against the auscultatory reference. The "algorithm only" aspect is inherent in the device's automated function.

6. The type of ground truth used:

   • Ground Truth: Expert consensus auscultatory readings obtained concurrently by trained observers using a mercury sphygmomanometer or validated equivalent are the standard ground truth for blood pressure monitor validation according to ANSI/AAMI IEC81060-2.

7. The sample size for the training set:

   • Training Set Sample Size: Not specified. Blood pressure monitor algorithms are typically developed using internal datasets, and the clinical validation (as discussed above) is usually a separate external validation.

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

   • Training Set Ground Truth: Not specified in this document. During algorithm development, it would likely involve carefully measured blood pressure data (potentially also using auscultatory reference) from a diverse population to train and optimize the oscillometric algorithm.

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF 1-2B is a device intended to measure the systolic and diastolic blood pressure, pulserate of an adult individual by using a non-invasive oscillometric technique in 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 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. The device can also be used in connection with smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The device detects the appearance of irregular heartbeat during measurement, and the symbol " " is displayed with the reading. The device can be used in connection with your personal computer (PC) running the software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable. The device can also be used in connection with smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.

The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria in the format requested.

The document is a 510(k) premarket notification for a blood pressure monitor, focusing on demonstrating substantial equivalence to a predicate device. It briefly mentions non-clinical and clinical tests but does not provide the specific data points requested in the prompt.

Here's a breakdown of what is mentioned, and what is missing:

What is mentioned:

• Non-Clinical Tests: The document states that testing was conducted in accordance with FDA guidance and various national and international standards (e.g., IEC 60601-1, AAMI/ANSI SP10, EN 1060-1, ISO 14971, AAMI/ANSI/IEC 80601-2-30). These standards typically define performance requirements and test methods for electrical safety, EMC, and blood pressure measurement accuracy.
• Clinical Tests: It explicitly states that repeat clinical testing in accordance with ANSI/AAMI IEC81060-2 for the subject device BP3NF1-2B was not necessary. The justification is that the subject device is technically identical to the predicate device (BP3MC1-PC) in terms of its blood pressure measurement algorithm and program codes, meaning their performance should be identical.
• Predicate Device: The clinical performance of the device is inferred from the performance of its predicate devices, specifically "Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC, K061471". While the standards listed (like AAMI/ANSI SP10 and AAMI/ANSI/IEC 80601-2-30) define accuracy requirements, the document does not report the specific performance metrics of the predicate device or the subject device against these requirements.
• Sample Size (Clinical): Not applicable for the subject device, as no new clinical study was performed.
• Ground Truth (Clinical): Not directly applicable for a new clinical study. The implied ground truth would be from the clinical studies conducted for the predicate device, likely using auscultation by trained observers.

What is missing from the provided text to fulfill your request:

1. A table of acceptance criteria and the reported device performance: This is the most crucial missing piece. While standards like AAMI/ANSI SP10 and IEC 81060-2-30 are mentioned, which contain accuracy criteria (e.g., mean difference and standard deviation between device and reference measurements), the document does not report the actual performance of the device against these criteria. It only states that the device "met all relevant requirements."
2. Sample sized used for the test set and the data provenance: Not provided, as no new clinical study was documented for this submission. This information would be found in the original clinical validation for the predicate device(s).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. This information would be part of the predicate device's clinical validation report.
4. Adjudication method: Not provided. This information would be part of the predicate device's clinical validation report.
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 a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device itself is a standalone algorithm for blood pressure measurement. However, the specific performance metrics are not reported here.
7. The type of ground truth used: Implied to be auscultatory reference measurements by trained observers for the predicate device's clinical validation, as per standard blood pressure validation protocols (e.g., AAMI/ANSI/ISO 81060-2).
8. The sample size for the training set: Not applicable. This document pertains to the evaluation of a medical device, not the development of a machine learning model with a distinct training set. The "algorithm" here refers to the oscillometric measurement method.
9. How the ground truth for the training set was established: Not applicable.

In summary, the document leverages the concept of substantial equivalence by arguing that no new clinical data is needed because crucial components, especially the measurement algorithm, are identical to a previously cleared predicate device. Therefore, the detailed acceptance criteria and performance data for the subject device are not presented, but are implicitly covered by the predicate device's prior approval against relevant standards.

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R) is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual by using a non-invasive oscillometric technique in one inflatable cuff is wrapped around the single upper arm.

The device detects the appearance of irregular heartbeat during measurements, and gives a warning signal with the reading once the irregular heartbeat is detected.

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

The device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R) is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well known technique in the market called the "oscillometric method".

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

The device detects the appearance of irregular heartbeat during measurement, and the symbol " " "is displayed after the measurement. In addition, the device can be used in connection with your personal computer (PC) running the software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable.

Here's a breakdown of the acceptance criteria and study information for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions clinical validation reports but does not explicitly state the sample size used for the clinical test set.

• Sample Size (Test Set): Not explicitly stated in the provided text for the clinical validation or other tests.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical validation report," implying prospective clinical testing.

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

This information is not provided in the text. The document refers to the ANSI/AAMI/ISO 81060-2:2009 and AAMI SP10 protocols for blood pressure measurement validation, which typically involve a specific number of observers (experts) for reference measurements. However, the exact number and qualifications of these experts are not detailed in this summary.

4. Adjudication Method for the Test Set

This information is not provided in the text. The AAMI protocols typically have specific requirements for how reference measurements are compared and adjudicated, but the summary does not elaborate on this for this specific study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication of an MRMC comparative effectiveness study involving human readers or AI in this document. This device is an automatic digital blood pressure monitor, not an AI-assisted diagnostic imaging or interpretation tool.

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

Yes, the primary clinical testing described is a standalone validation of the device's accuracy in measuring blood pressure and detecting irregular heartbeats, according to the ANSI/AAMI/ISO 81060-2:2009 protocol. This protocol evaluates the device's performance without human interpretation or assistance beyond the typical operation of a blood pressure monitor.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the blood pressure accuracy validation, the ground truth would be established through reference measurements taken by trained observers using a calibrated sphygmomanometer (or similar reference method) according to the ANSI/AAMI/ISO 81060-2:2009 protocol. This often involves simultaneous or nearly simultaneous measurements with the test device and a highly accurate reference method. For "irregular heartbeat detection," the ground truth would likely be established by a physician's or cardiologist's diagnosis using an ECG or other standard diagnostic methods.

8. The Sample Size for the Training Set

This device is based on the "oscillometric method," which is a well-known and established technique for blood pressure measurement. While software is involved in analyzing the signals, the document does not suggest a machine learning model that would require a distinct "training set" in the modern sense (i.e., for deep learning or AI). The software algorithm is described as using the "well-known oscillometric method." Therefore, the concept of a separate "training set" for an AI model, as typically understood, does not apply in this context.

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

As explained under point 8, the concept of a "training set" for an AI model with a distinct ground truth establishment method is not applicable to this device. The oscillometric method itself is based on established physiological principles and signal analysis techniques, not a data-driven machine learning training process described in the document.

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GT1-6X 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.

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

The device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GT1-6X is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive MAM (Microlife Average Mode) technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses a capacitor 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".
And the device has Irregular Heartbeat Detection (IHD) function. It detects the appearance of irregular heartbeat during measurement and the irregular heart beat symbol "is displayed on the LCD screen if any irregular heart beat signal has been detected. In addition, the device has a traffic light function. And the device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.
· The device features an interactive touch screen which operates similarly to traditional buttons, but requires only a light touch of the finger to operate.

Here's a breakdown of the acceptance criteria and study information for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GT1-6X, based on the provided text:

Key Finding: The submission does not contain a standalone clinical study for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GT1-6X. Instead, it relies on a declaration of clinical identity and substantial equivalence to a previously cleared predicate device, Model BP3AP1-3E.

1. Table of Acceptance Criteria and Reported Device Performance

• Storage test
• Operating test
• Vibration test
• Drop test
• Life test |
  | EMC (Electromagnetic Compatibility) | Met requirements. |
  | Electrical, Mechanical, Environmental Performance | Met all relevant requirements as per FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND. |
  | Software Validation | Conducted in accordance with:
• FDA November 2005 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (moderate level of concern)
• FDA September 1999 "Guidance for Off-The-Shelf Software Use in Medical Devices" (for PC-link function) |

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

• Sample Size: Not applicable. No dedicated clinical test set for blood pressure accuracy was performed for this specific device model.
• Data Provenance: Not applicable for a new clinical study. The device's clinical accuracy is inferred from a predicate device.

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

• Number of Experts: Not applicable. No new clinical study was conducted for this device.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No new clinical study was conducted for this device.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.

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

• Standalone Study: No, a standalone clinical accuracy study for blood pressure measurement was not done for this specific device. The clinical accuracy is based on the technical identity to a predicate device, which itself would have undergone such validation against a standard like ANSI/AAMI SP10.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the claim of blood pressure accuracy, the ground truth would have been established through a clinical validation study of the predicate device (Model BP3AP1-3E) in accordance with a recognized standard like ANSI/AAMI SP10. This standard typically involves comparison against mercury sphygmomanometry (auscultatory method performed by trained observers).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device uses an oscillometric method, not a machine learning algorithm that typically requires a 'training set' in the conventional sense. The "training" for such devices is inherent in their design and calibration based on established physiological principles and prior validation data from similar devices.

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

• Ground Truth for Training Set: Not applicable in the context of an AI/ML training set. The calibration and underlying principles of the oscillometric method are based on established medical science and validated against clinical standards.

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