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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 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ ( BP4GAPO-2M ) 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 Cardio+ (BP4GAPO-2M) achieves its function by integrating the device with an iPhone, iPad, or iPod Touch.

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 via cable with the PC.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ (BP4GAPO-2M) 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 Cardio+ (BP4GAPO-2M) achieves its function by integrating the device with an iPhone, iPad, or iPod Touch. Because the device does not contain an LCD or other display components, it is necessary for the device to connect with an iPhone, iPad, or iPod Touch containing supporting software to constitute a complete blood pressure measure system.

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.

Due to the nature of the provided text, which primarily describes a 510(k) premarket notification for a blood pressure monitor, it does not contain the detailed information typically found in a study report regarding acceptance criteria and performance of the device against those criteria.

Specifically, the document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical tests (reliability, EMC, safety) and stating that clinical testing for blood pressure accuracy is "not required" because the core measurement technology is identical to a previously cleared device.

Therefore, for the requested information, the following points can be extracted or noted as explicitly not provided in the given text:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study that proves the device meets the acceptance criteria:

The document states:

• "The subject modified device Model Cardio+ (BP4GAPO-2M) is, from the technical point of view, identical to the blood pressure monitor Model BP3AC1-1 PC. The differences between these two devices do not relate to blood pressure measurement technology. Therefore, the clinical accuracy in terms of blood pressure detection will not be affected. Based on this, repeated clinical testing in accordance with ANSI/AAMI SP10 is therefore not required."

This indicates that no new clinical study was performed or presented in this 510(k) submission to directly prove the device's accuracy against specific acceptance criteria. Instead, the argument for substantial equivalence relies on the technical identity of the blood pressure measurement technology with a predicate device (Model BP3AC1-1 PC) that would have previously met such clinical accuracy standards (e.g., ANSI/AAMI SP10).

Additional Information (Extracted or Not Provided):

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

  • Not provided. No new clinical test set was described for blood pressure accuracy.

• 3. 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):

  • Not provided. No new clinical test set was performed.

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

  • Not provided. No new clinical test set was performed.

• 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/Not provided. This device is a blood pressure monitor, not an AI-assisted diagnostic tool.

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

  • Not applicable/Not provided in the context of diagnostic performance. The device is an automated blood pressure monitor. Its "algorithm" (oscillometric method) is inherent to its function, and its performance is assumed to be equivalent to the predicate.

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

  • Not explicitly stated for this submission. For blood pressure monitors, ground truth for clinical accuracy studies typically involves concurrent measurements by trained observers using a mercury sphygmomanometer (auscultatory method), often following standards like ANSI/AAMI SP10. The submission states that the predicate device would have met such standards.

• 8. The sample size for the training set:

  • Not applicable/Not provided. This is not an AI/machine learning device that involves a training set in the typical sense. The "training" would refer to the development and calibration of the oscillometric algorithm in the predicate device, for which details are not in this document.

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

  • Not applicable/Not provided. (See point 8).

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D 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 atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive MAM (Microlife Average Mode) technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

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

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criteria for the atrial fibrillation (AF) detection function of the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D, are related to its sensitivity and specificity in detecting AF when compared to an electrocardiogram (ECG) as ground truth. While no explicit quantitative "acceptance criteria" are stated as a minimum threshold in the document, the studies demonstrate the device's performance against expected clinical measures.

The studies compared two methods of analyzing the BP3MQ1-2D readings: individual readings and combined (three sequential) readings. The combined readings generally show higher performance, likely reflecting how a user might be instructed to use the device (e.g., taking multiple readings for confirmation).

Note: The document also references a prior test of the AfibAlert™ algorithm (the underlying AF detection component), which showed 92% sensitivity and 96% specificity against the MIT-BIH AFIB database. This indicates a pre-existing level of performance for the core algorithm, which was then validated within the new device.

Study Details Proving Device Meets Acceptance Criteria:

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

• TRIPPS 1.0: 205 subjects
• TRIPPS 1.1: 157 subjects
• Combined Studies: 362 subjects (205 + 157)
• Data Provenance: The document does not explicitly state the country of origin for the TRIPPS studies. The studies are described as "clinical trials," implying prospective data collection for the purpose of validating the device. The MIT-BIH AFIB database for the AfibAlert™ algorithm is a publicly available, retrospective database of ECG recordings, but this was for the underlying algorithm, not the device's clinical validation.

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

• The document states that the ECG readings were "read in a blinded fashion" to establish ground truth.
• Number of experts: Not explicitly stated.
• Qualifications of experts: Not explicitly stated.

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

• The document does not explicitly describe an adjudication method for disagreements in ECG interpretation, only that ECG readings were obtained and "read in a blinded fashion."

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, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done.
• The clinical studies described (TRIPPS 1.0 and 1.1) were standalone performance studies of the device's AF detection capabilities against an ECG reference.

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

• Yes, a standalone performance evaluation was conducted. The entire purpose of the clinical trials (TRIPPS 1.0 and 1.1) was to evaluate the device's automatic AF detection capabilities (algorithm only) compared to the ECG ground truth. The tables provided (Table 1 and Table 2) directly present the standalone performance of the BP3MQ1-2D in detecting AF.

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

• Electrocardiogram (ECG) readings. For the clinical validation studies (TRIPPS 1.0 and 1.1), the rhythm determined by an ECG was used as the ground truth.

8. The sample size for the training set:

• The document does not specify the sample size for any training set related to the BP3MQ1-2D's algorithm. It mentions that the "AfibAlert™ algorithm was tested using published available annotated MIT-BIH AFIB database," which would be a test or validation set for that specific algorithm, not necessarily a training set for the overall device's AF detection function. For the BP3MQ1-2D itself, no training set information is provided in this document.

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

• As the training set information is not provided for the BP3MQ1-2D's AF detection algorithm, the method for establishing its ground truth also cannot be determined from this document. If we assume the AfibAlert™ algorithm was "trained" on data, the MIT-BIH AFIB database is mentioned as an "annotated" database, implying expert annotations for ground truth, but this is used for testing and not explicitly stated as training.

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The Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

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

Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50) is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well known technique in the market called the "oscillometric method".

The device detects the appearance of irregular heartbeat during measurement and the irregular heart beat symbol " irreqular heart beat signal has been detected.

This document describes the 510(k) submission for the Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50). The primary claim of substantial equivalence is based on its similarity to a previously cleared device, Model BP2BI0, with the addition of an irregular heartbeat detection function inherited from another cleared device, Model BP3BT0-AP.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria in a table format for accuracy. Instead, it refers to compliance with a recognized standard, ANSI/AAMI SP10: 2002 "National Standard for Noninvasive Sphygmomanometers".

2. Sample Size for Test Set and Data Provenance

The document states:
"Since the cleared device, BP2BI0, and the program codes of the BP3MR1-H(BP A50) remain unchanged and the fundamental scientific technology of the modified device is the same as the 510(k) cleared device, BP2BI0. Clinical performance of the modified device will remain unchanged; therefore another clinical test for the modified device, BP3MR1-H(BP A50) is not required."

This indicates that no new clinical test set was used for the BP3MR1-H(BP A50) to demonstrate its blood pressure measurement accuracy. The clinical performance is inferred from the predicate device (BP2BI0). Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a new test set for the BP3MR1-H(BP A50) device is not provided.

For the irregular heartbeat detection feature, it is stated that the technology is the "same as what is used in Microlife Upper Arm Automatic Blood Pressure Monitor, model BP3BT0-AP, with 510(K) cleared number K#041411." To understand the sample size and data provenance for the irregular heartbeat detection, one would need to refer to Exhibit#3, which contains the 510(k) summary for BP3BT0-AP. This information is not available in the provided text.

3. Number of Experts and Qualifications for Ground Truth of Test Set

As no new clinical test was conducted for the blood pressure measurement accuracy of the BP3MR1-H(BP A50), this information is not provided. If an ANSI/AAMI SP10 study was performed for the predicate device (BP2BI0), it would typically involve trained observers (likely clinicians or medical professionals) taking reference measurements, but the specifics are not detailed here. For the irregular heartbeat detection, the information might be in the 510(k) for BP3BT0-AP, but is not provided in the given text.

4. Adjudication Method for Test Set

Since no new clinical test was conducted for the blood pressure measurement accuracy of the BP3MR1-H(BP A50), this information is not applicable/provided. For studies adhering to ANSI/AAMI SP10, there are specific requirements for agreement between observers, which implicitly involves a form of "adjudication" if discrepancies arise, but the details are not given here. For the irregular heartbeat detection, the information might be in the 510(k) for BP3BT0-AP, but is not provided in the given text.

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

No MRMC comparative effectiveness study was mentioned or conducted, as the device is a standalone blood pressure monitor and does not involve human readers interpreting its output in a comparative AI-assisted vs. non-AI-assisted scenario. Therefore, not applicable, and no effect size for human readers with/without AI assistance is provided.

6. Standalone Performance Study

A standalone performance evaluation (algorithm only without human-in-the-loop) for blood pressure measurement accuracy was implied to have been conducted for the predicate device (BP2BI0) in accordance with ANSI/AAMI SP10: 2002. The current device's performance is asserted to be unchanged due to identical programming and fundamental technology.

A standalone performance evaluation for the irregular heartbeat detection feature was likely conducted for the predicate device BP3BT0-AP, as the technology is stated to be derived from it. The specifics are not provided in the given text but would be in the 510(k) for BP3BT0-AP.

7. Type of Ground Truth Used

For blood pressure measurement accuracy, the ground truth for studies adhering to ANSI/AAMI SP10 typically involves simultaneous auscultatory measurements performed by trained observers using a mercury manometer or a validated reference device. This is a form of expert consensus/reference measurement.

For irregular heartbeat detection, the ground truth for the BP3BT0-AP (from which this device's technology is derived) would typically involve a gold standard like electrocardiogram (ECG) recordings. This implies outcomes data/reference standard.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning, as this is a traditional medical device (oscillometric blood pressure monitor) and not explicitly an AI/ML-driven device in the modern sense. The "program codes" for the BP3MR1-H(BP A50) are stated to be "unchanged" from the predicate BP2BI0, implying that any underlying algorithms were developed and "trained" (or validated) as part of the predicate device's clearance. Therefore, a specific training set size for this device is not provided or explicitly applicable in the context of its submission strategy.

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

Similar to point 8, the concept of a "training set" with distinct ground truth establishment for this device is not directly applicable given the submission strategy of substantial equivalence to a predicate. The underlying algorithms for the core oscillometric measurement and irregular heartbeat detection would have been developed and validated using relevant physiological data (e.g., simultaneous auscultatory readings or ECGs) in accordance with recognized standards for the predicate devices. The specifics of how this ground truth was established for the predicate devices are not detailed in the provided text.

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The Microlife Wrist Watch Blood Pressure Monitor, Model BP 3MK1-3 (BP W100) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.

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

Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3(BP W100) is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The device detects the appearance of irregular heartbeat during measurement and the irregular heart beat symbol " irregular heart beat signal has been detected.

Here's a summary of the acceptance criteria and study information for the Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100), based on the provided text:

Acceptance Criteria and Device Performance:

The document explicitly states that the device's performance is compared to its predicate device (BP3BU1) and other models (BP3BT0-AP) based on non-clinical and clinical testing. Crucially, the application for this model (BP3MK1-3) argues that no new clinical testing is required because the measurement algorithm and program codes are unchanged from the predicate device and the fundamental scientific technology is the same. Therefore, the device meets the acceptance criteria by being demonstrated as equivalent to an already cleared device that met the ANSI/AAMI SP10-2002 standard.

Study Details:

Since the submission claims substantial equivalence to a predicate device (BP3BU1) and states that "anther clinical test for the modified device, BP3MK1-3(BP W100) is not required" due to unchanged algorithms and technology, the following details pertain to the implication of that claim rather than direct studies for this specific device model. The document does not provide details of the original clinical study for the predicate device BP3BU1 beyond mentioning compliance with ANSI/AAMI SP10-2002.

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

   • Test Set Sample Size: Not explicitly stated for either non-clinical (reliability, EMC) or clinical (from predicate) tests.
   • Data Provenance: Not specified for the predicate device's clinical testing. The non-clinical tests (reliability, EMC) for the BP3MK1-3 were conducted by the manufacturer.

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

   • This information is not provided for the predicate device's clinical testing, nor is it relevant for the non-clinical tests conducted for the BP3MK1-3.

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

   • Not provided for the predicate device's clinical testing.

4. 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 is a blood pressure monitor, not an AI-assisted diagnostic imaging device for human readers.

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

   • The core functionality of the device is to measure blood pressure using an oscillometric method, which is an algorithm-only measurement. The document states the "measurement algorithm and the program codes of the BP3MK1-3(BP W100) remain unchanged." This implies standalone performance was measured for the predicate and is assumed for this device. Specific performance metrics (accuracy, precision) are not detailed but are implied to meet the ANSI/AAMI SP10-2002 standard.

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

   • For blood pressure monitors seeking compliance with standards like ANSI/AAMI SP10, the "ground truth" typically involves simultaneous measurements by trained observers using a mercury sphygmomanometer (auscultatory method), often double-blinded, which serves as the "reference method." This would have been the case for the predicate device's clinical testing.

7. The sample size for the training set:

   • Not applicable as this is not an AI/machine learning device that uses a "training set" in the conventional sense. The "training" of the device refers to its design and calibration based on known physiological principles and validated algorithms.

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

   • Not applicable (see point 7).

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The Microlife Upper Arm Blood Pressure Monitor, Model BP 3BT0-AP, is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

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

The Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-AP is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

Here's an analysis of the provided text regarding the Microlife Blood Pressure Monitor, Model BP3BT0-AP:

Acceptance Criteria and Study Details for Microlife Blood Pressure Monitor, Model BP3BT0-AP

The provided 510(k) summary focuses primarily on establishing substantial equivalence to predicate devices based on the blood pressure measurement algorithm and a separate simulator study for the irregular heartbeat detection function.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Blood Pressure Measurement: No specific test set or data provenance for blood pressure measurement is described. The submission states that "no clinical validation for blood pressure measurement is required" because the algorithm is identical to that of the predicate device (BP3BT0-1).
• Irregular Heartbeat Detection: The submission mentions a "simulator comparison study."
  • Sample Size: Not specified for this simulator study.
  • Data Provenance: The nature of a "simulator" implies artificially generated or controlled data, not human patient data from a specific country. It's a prospective study in the sense that the simulator tests were performed specifically for this submission.

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

• Blood Pressure Measurement: Not applicable, as no new clinical validation was performed for the blood pressure algorithm. Ground truth for the predicate device would have been established according to relevant standards (e.g., ANSI/AAMI SP10-1992), likely requiring a panel of experts often including physicians or trained clinical staff.
• Irregular Heartbeat Detection: Not specified. Since it was a simulator study, the "ground truth" would be determined by the simulator's programmed conditions for irregular heartbeats and standard definitions of such events. Experts (e.g., biomedical engineers, cardiologists) might have designed or validated the simulator's output, but this is not explicitly stated.

4. Adjudication Method for the Test Set

• Both are not applicable directly from this summary. For the simulator study, adjudication methods are less typical than for human reader studies, as the truth is defined by the simulator itself.

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 MRMC comparative effectiveness study was done or mentioned. This submission does not describe an AI system designed to assist human readers; it's a standalone device that provides measurements.

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

• Yes, the device operates in a standalone manner. The blood pressure measurement algorithm is described as "oscillometric method" which is inherent to the device's function. The irregular heartbeat detection is also an algorithmic function within the device. The "simulator comparison study" for irregular heartbeat detection would evaluate this standalone algorithmic performance.

7. The Type of Ground Truth Used

• Blood Pressure Measurement: Implicitly, the ground truth for blood pressure measurement would be the auscultatory method (mercury manometer with stethoscope) as defined by the standards (e.g., ANSI/AAMI SP10-1992) that the predicate device would have followed.
• Irregular Heartbeat Detection: The ground truth for the simulator study would be the pre-defined, programmed irregular heartbeat patterns generated by the simulator.

8. The Sample Size for the Training Set

• Blood Pressure Measurement: Not explicitly stated. The algorithm is "exactly the same as in the predicate device, BP3BT0-1." The training data for the original predicate device's algorithm is not provided here.
• Irregular Heartbeat Detection: Not explicitly stated. The irregular heartbeat detection function is new to this specific model compared to the BP3BT0-1 predicate but is present in the A&D Medical Lifesource predicate. It's possible the algorithm was developed (trained, if applicable) using internal data or known irregular heartbeat signal patterns, but no details are given.

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

• Blood Pressure Measurement: Not explicitly stated. For the predicate device's algorithm, the ground truth would have been established through clinical trials comparing oscillometric readings against a gold standard like the auscultatory method, following established protocols (e.g., those in ANSI/AAMI SP10).
• Irregular Heartbeat Detection: Not explicitly stated. If the irregular heartbeat detection algorithm involved machine learning (unlikely given the 2004 submission date, but possible for rule-based systems), its ground truth would have been based on expert-labeled physiological signals or known irregular heartbeat patterns. However, the submission doesn't provide this level of detail.

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This device is intended for monitoring PEF (Peak Expired Flow Rate) for patient home use. The device is designed for pediatric to adult patients. The simple device interface provides ease of use for pediatric patients. When the device is used to monitor lung conditions such as asthma, the user should be under the care of a licensed health care professional. A licensed health care professional's advice is required to understand the meaning and importance of the measurements reported by the device and how to decide on an appropriate treatment plan. This treatment plan will tell the patient what action to take when there are changes in their PEF measurements.

The Microlife Electronic Peak Flow Monitor. Model PF-100. comprises a hand held microprocessor based unit, incorporating a removable micro medical digital volume transducer. The transducer consists of an acrylic tube with a freely rotating vane supported on jeweled bearings positioned between a fixed swirl plate and a cross bar. As air is passed through the transducer, a vortex is created by the swirl plate, which causes the low inertia vane to rotate. The rotation of the vane is detected by the interruption of an infrared beam which produces an electrical pulse train at the output of a phototransistor. The number of rotations is proportional to the volume of air passed through the turbine, and the rate of rotation is proportional to the flow rate.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Microlife Electronic Peak Flow Monitor, Model PF-100:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document explicitly states that the device was tested using "the ATS Standard Waveforms." However, it does not specify the number of waveforms or the duration of these tests. It only mentions "using the 26 flowtime waveform" in the description of the measuring principle, which might imply the type of waveform used by the ATS standard but not the sample size of tests performed.
• Data Provenance: Not specified, but given the manufacturer (Microlife Corporation) is from Taiwan and the submission is to the FDA in the USA, the testing was likely conducted by the manufacturer or a contracted lab to demonstrate compliance for US market approval. The data would be considered retrospective as it was generated specifically for the submission.

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

• Not Applicable. The ground truth for the performance claim (flow accuracy) was established directly by the ATS Standard Waveforms using a "waveform generator." This implies a standardized, objective set of conditions rather than expert interpretation of medical data. For electrical safety and electromagnetic compatibility, the ground truth is defined by the respective IEC standards, again not requiring human expert interpretation in the context of this submission.
• The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This further confirms that human expert-derived ground truth from patient data was not a component of this submission's testing.

4. Adjudication Method for the Test Set

• Not Applicable. As the ground truth was established by standardized waveforms and objective technical standards (ATS, IEC), there was no need for human adjudication of results. The device's output was compared directly against the known, precise values of the generated waveforms or compliance criteria of the technical standards.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This type of study would involve human readers (healthcare professionals) using the device with and without AI assistance (though this device does not appear to have AI) on multiple patient cases, which was not part of the submitted evidence.

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

• Yes, a standalone performance assessment was conducted. The "subject device was tested to and passed the ATS Standard Waveforms using a waveform generator." This is an assessment of the device's inherent accuracy and performance characteristics in isolation, without a human operator's influence on the measurement itself (though a human activates the test and reads the result). Electrical safety and EMC testing are also standalone assessments.

7. The Type of Ground Truth Used

• Standardized Waveforms and Technical Standards:
  • For performance (flow accuracy): The ATS Standard Waveforms, generated by a "waveform generator." This represents a highly controlled, objective, and reproducible standard.
  • For safety and EMC: IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility). These are objective technical standards.

8. The Sample Size for the Training Set

• The document describes a physical device with a "removable micro medical digital volume transducer," not a software algorithm that would typically require a training set in the context of AI. Therefore, Not Applicable. The device's function is based on physical principles (vortex creation, vane rotation, infrared beam interruption) rather than a learned model from data.

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

• Not Applicable. As there is no training set for this type of device, this question is not relevant.

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The Microlife Digital Basal Thermometer is a device intended for measuring, and aiding in the monitoring and tracking of basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).

The Microlife Digital Basal Thermometer, which uses the Basal Temperature method can be used for helping in family planning in healthy adults by understanding their menstrual cycle and ovulation and interpreting basal temperature changes. This Thermometer provides easy, quick and highly accurate readings over the body temperature range. The body temperature is measured by the thermistor (inside the probe tip) and displayed as numbers on the LCD (liquid crystal diplay) through microprocessor of IC. The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit. Therefore, temperature can be given by measuring the frequency of oscillator. For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.

The provided text describes the Microlife Digital Basal Thermometer and its 510(k) submission, confirming its substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria or the specifics of a study that proves the device meets those criteria in the way requested by the prompt.

The document states:

• "Controlled human clinical studies were conducted using the Microlife Digital Basal Thermometer MT1921 for measurement and accuracy."
• "Compliance to applicable voluntary standards includes ASTM E1112, as well as IEC60601-1 and IEC60601-1-2 requirements."
• "Guidance documents included the "FDA Guidance on the Content of Premarket Notification 510(K) Submissions for Clinical Electronic Thermometers."

While these statements indicate that testing was performed and standards were met, the actual acceptance criteria values and the results of those tests are not provided in the summary. Therefore, directly filling out most of the requested fields is not possible from the given input.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

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

• Sample size: Not specified.
• Data provenance: "Controlled human clinical studies were conducted," but country of origin and retrospective/prospective nature are not specified.

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

• Not specified. The document does not describe the establishment of a ground truth by experts for the clinical studies.

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

• Not specified.

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/Not done. This device is a thermometer, not an AI-assisted diagnostic tool that would involve "human readers" or "AI improvement." The study focused on the accuracy of the device itself.

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

• This device is a standalone electronic thermometer. The "controlled human clinical studies" would have assessed the device's performance in human subjects, implying a standalone assessment of the device's ability to measure temperature.

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

• Given it's a thermometer, the ground truth for accuracy would typically be a reference thermometer or a calibrated temperature standard against which the device's readings are compared. This is implied by "measurement and accuracy" testing and compliance with ASTM E1112 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature).

8. The sample size for the training set:

• Not applicable/Not specified. This device is a hardware-based electronic thermometer, not an AI/ML algorithm that requires a separate training set. The "human clinical studies" are for validation/testing, not training.

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

• Not applicable. (See #8)

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The Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1-5 is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. This device can be used in connection with the Microlife Thermal Printer, Model PR 1KA1.

The Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1-5 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which as inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronics capacitive pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".

The provided document describes the Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1-5. However, it does not contain the detailed acceptance criteria or a specific study proving the device meets new acceptance criteria. Instead, it asserts substantial equivalence to a predicate device based on the predicate device's performance and a series of non-clinical tests.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the new device's blood pressure or pulse rate accuracy. It relies on the predicate device's performance.

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

The document does not provide details on the sample size used for the clinical test set or the data provenance (country of origin, retrospective/prospective). It explicitly states: "Repeat testing was not performed for the modified device, as clinical testing results were not affected by the changes to the modified device." This implies that the clinical data referred to pertains to the predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide any information on the number of experts or their qualifications for establishing ground truth, as new clinical testing was not performed for the modified device. The reference to "ANSI/AAMI 'National Standard for Electronic or Automated Sphygmomanometers'" implies that the ground truth for the predicate device's validation would have followed the methodology outlined in this standard, which typically involves trained observers and mercury sphygmomanometers.

4. Adjudication Method for the Test Set

The document does not provide any information on an adjudication method, as new clinical testing was not performed for the modified device.

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

No, an MRMC comparative effectiveness study was not done. The 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

The device is inherently a standalone measurement device. Its performance, as validated by the ANSI/AAMI standard for the predicate, would represent its standalone accuracy. The non-clinical tests (e.g., General Functions, Reliability, Pulse Rate Accuracy) assess the algorithm and hardware without human intervention for interpreting results.

7. The Type of Ground Truth Used

For the predicate device's clinical validation (which is being leveraged for substantial equivalence), the ground truth for blood pressure measurements would typically be established using simultaneous auscultation by trained observers with a mercury sphygmomanometer, as per the methodology of the ANSI/AAMI standard. This is considered an expert consensus or reference method.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. The device uses an "oscillometric method" which is a "well-known technique in the market." This suggests that the underlying algorithms were developed and refined over time based on established physiological principles and data, rather than being a novel machine learning algorithm that requires a dedicated training set as understood in modern AI contexts. The "temperature measurements algorithm and its software codes of the modified devices remains unchanged."

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

As above, the concept of a "training set" as in machine learning is not directly applicable here. The "oscillometric method" relies on analyzing pressure oscillations in the cuff. The fundamental principles and parameters for this method would have been established through extensive research and validation against reference methods (like auscultation) in the development of such devices generally. The document does not describe the specific ground truth establishment for the development of the oscillometric algorithm itself, only the validation of the device against accepted standards.

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The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

The Microlife Digital Infrared Ear Thermometer, Model IR1DE1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Their operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces.

The Microlife Digital Infrared Ear Thermometer, consists mainly of the five parts:

• IR Thermopile Sensor a)
• ASIC b)
• E2 PROM IC C)
• LCD and Blacklight d)
• Kev "2. Buzzer" 1 e)

Here's an analysis of the provided text regarding the acceptance criteria and study for the Microlife Digital Infrared Ear Thermometer, Model IR1DE1:

Key Finding: This 510(k) submission does not contain any clinical study data for the IR1DE1 model. It relies on the substantial equivalence to a previously cleared device (IR1DA1) and states that clinical studies were already conducted for the original, unmodified device. Therefore, a complete table of acceptance criteria and reported device performance directly from this document, as well as several other requested details, cannot be provided.

Acceptance Criteria and Study Details for Microlife Digital Infrared Ear Thermometer, Model IR1DE1

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, specific numerical acceptance criteria and reported device performance from a new study for the specific model IR1DE1 are not available. The submission states that compliance to various standards was performed, but it does not detail specific performance thresholds or results.

However, the document indicates compliance with the following:

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

• Test Set Sample Size: Not applicable. No new clinical human testing was conducted for this specific modified device (IR1DE1).
• Data Provenance: Not applicable for new clinical data. The submission refers to "clinical studies/low power testing were conducted for the original unmodified device," but details of those prior studies are not provided in this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. No new clinical studies requiring expert ground truth establishment for a test set were conducted for this device according to the document.

4. Adjudication Method for the Test Set:

• Not applicable. No new clinical studies were conducted for this device.

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

• No, a MRMC comparative effectiveness study was not done for the modified device (IR1DE1). Clinical studies were explicitly not conducted for this modified device.

6. Standalone Performance Study:

• No, a standalone (algorithm only without human-in-the-loop) performance study was not done specifically for the modified device (IR1DE1) as a new clinical study. The submission states that "Accuracy performance, reliability and EMC testing is only applicable," suggesting engineering and bench testing, but no specific in-depth performance study results are detailed in this document.

7. Type of Ground Truth Used:

• Not applicable for new clinical data. The ground truth for the original device's clinical studies (referenced but not detailed here) would likely have been reference thermometer readings or medical consensus, but this is speculative given the lack of detail.

8. Sample Size for the Training Set:

• Not applicable. The device's temperature measurement algorithm and software codes "remain unchanged" from the predicate device. Therefore, no new training set was used for the IR1DE1 model. The document does not provide details on the training set (if any, as an infrared thermometer might not 'train' in the AI sense) used for the original algorithm development.

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

• Not applicable, as no new training set was described for the IR1DE1 model. Details on the ground truth establishment for the original algorithm are not provided in this document.

Summary of the Submission's Approach:

The submission for the Microlife Digital Infrared Ear Thermometer, Model IR1DE1, is a 510(k) for a modified device. The core argument for substantial equivalence relies on:

1. The device having the same intended use as the predicate device (Model IR1DA1).
2. The temperature measurement algorithm and software codes remaining unchanged.
3. The fundamental scientific technology remaining the same.
4. Modifications being limited to "ergonomics of the user interface, dimensional specifications and environmental specifications," and PCB layout, which are considered to not affect the intended use or alter the fundamental scientific technology.
5. Compliance with applicable voluntary standards and guidance documents.

Therefore, the submission explicitly states: "Controlled human clinical studies were not conducted for the Microlife Digital Infrared Ear Thermometer modified devices, as well as no low power test as clinical studies/low power testing were conducted for the original unmodified device and remain unchanged." This means no new primary clinical data for the IR1DE1 model is presented in this document.

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