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The Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B 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 wrist for a circumference range from 13.5 to 21.5cm. 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.

Microlife Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B is designed to measure 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 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 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. In addition, the device can be used in connection with smart mobile devices running the APP and via Bluetooth.

The provided text does not contain information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of performance metrics like accuracy for the subject device (Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B).

Instead, it states that:

• The subject device is considered "identical" to a predicate device (BP3NN1-3E, K151330) from a clinical validation standpoint for blood pressure measurement.
• Therefore, "no repeated clinical testing was required for blood pressure measurement to support BP3GK1-4B as the subject device can leverage the clinical validation of BP3NN1-3E that was proven in K151330."

To answer the request fully, the clinical validation study for the predicate device (BP3NN1-3E, K151330) would need to be reviewed. The provided document points to "AAMI / ANSI/IEC81060-2" as the standard for clinical validation, but it does not detail the specific results for the predicate or subject device against those criteria within this submission.

Therefore, I cannot populate the table or answer all the sub-questions directly from the provided text for the subject device.

However, I can extract the general accuracy criteria typically expected for such devices, as mentioned in the comparison table for Pressure and Pulse Rate Accuracy, which is shared between the subject device and Predicate device No.1.

Here's what can be extracted based on the provided text's limited information regarding performance for the subject device, and an acknowledgement of assumptions made based on shared specifications with the predicate device:

Acceptance Criteria and Device Performance (Based on shared specifications with Predicate Device No.1, as a clinical study was not performed on the subject device due to substantial equivalence claim):

There is no specific clinical study detailed for the subject device (BP3GK1-4B) in this document to prove it meets acceptance criteria, as the manufacturer claims substantial equivalence to a predicate device (BP3NN1-3E, K151330) and leverages its clinical validation. The acceptance criteria listed below are common performance specifications for such devices, and for this submission, the subject device is considered to meet these based on its substantial equivalence to the predicate device which presumably met these in its own 510(k) submission (K151330).

1. Table of Acceptance Criteria and the Reported Device Performance (for clinical accuracy)

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

• Not provided for the subject device (BP3GK1-4B). The document explicitly states: "There was no repeated clinical testing required for blood pressure measurement to support BP3GK1-4B as the subject device can leverage the clinical validation of BP3NN1-3E that was proven in K151330."
• To obtain this information, the 510(k) submission K151330 for the predicate device BP3NN1-3E would need to be reviewed.

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

• Not provided for the subject device. This information would be within the clinical validation study of the predicate device (K151330), if detailed. Blood pressure monitor validation studies typically involve comparison against reference measurements taken by trained operators.

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

• Not provided for the subject device. This information would be within the clinical validation study of the predicate device (K151330), if detailed. Standards like AAMI/ANSI/IEC 81060-2 specify requirements for comparing automated blood pressure measurements against auscultatory measurements by human observers.

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 an automated blood pressure monitor for direct blood pressure and pulse rate measurement, not an AI-assisted diagnostic tool for human readers. It does not involve "human readers" in its primary function for diagnosis, but rather provides direct readings to the user.

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

• Yes, implicitly. The device operates standalone to provide blood pressure readings. The claim of substantial equivalence for blood pressure measurement performance means the device's algorithm performs its intended function without human intervention in the measurement process itself. The clinical validation referenced by the predicate (K151330) against the AAMI / ANSI/IEC81060-2 standard would have assessed this standalone performance against reference measurements.

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

• Presumed to be reference blood pressure measurements. For blood pressure monitors, the ground truth is typically established using a reference method, such as auscultatory measurement by trained observers using a mercury sphygmomanometer or another validated reference device, following international standards like AAMI/ANSI/IEC 81060-2.

8. The sample size for the training set:

• Not applicable / Not provided. For a hardware device with an embedded algorithm like this, there isn't typically a "training set" in the machine learning sense for the end-user product. The algorithm development may have involved internal data for calibration and optimization, but this is distinct from a clinical validation "test set." The document does not provide details on algorithm development data.

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

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

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The Wrist Watch Blood Pressure Monitor, Model BP3NN1-3E 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 wrist for a circumference range from 13.5 to 21.5cm.

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 BP3NN1-3E is designed to measure 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 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 can detect electrical signals while inflating . And the device has Irregular Heartbeat Detection (IHD) function. It detects the appearance of irregular heartbeat during measurement and the irregular heart beat symbol "MA" is displayed on the LCD screen if any irregular heart beat signal has been detected. In addition, the device has traffic light function.

This document describes the Microlife Wrist Watch Blood Pressure Monitor, Model BP3NN1-3E, and its substantial equivalence to predicate devices, particularly concerning its performance characteristics.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than explicitly stating acceptance criteria and then presenting a direct comparison. However, the regulatory standards cited implicitly define the acceptance criteria for non-invasive blood pressure measurement devices.

The key performance aspect mentioned is the blood pressure measurement accuracy and the Irregular Heartbeat Detection (IHD) function.

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

The document explicitly states: "Repeat clinical testing in accordance with the standard ANSI/AAMI IEC81060-2 for the subject device BP3NN1-3E is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device."

Therefore, a new, separate clinical test set for the BP3NN1-3E model was not used for demonstrating blood pressure measurement accuracy. The reliance is on the clinical data for the predicate device BP3MO1-3P.

• Sample Size for Test Set: Not applicable for the BP3NN1-3E's blood pressure measurement accuracy. The performance is inferred from the predicate device (BP3MO1-3P). The document does not specify the sample size for the predicate's original clinical study, nor its data provenance.
• Data Provenance: Not applicable for a new clinical study of the BP3NN1-3E. For the predicate device, it is not specified in this document.

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

This information is not provided for the BP3NN1-3E device as a new clinical study for blood pressure measurement accuracy was deemed unnecessary. For the predicate device's original clinical validation, this detail is absent from the provided text.

4. Adjudication Method for the Test Set

This information is not provided for the BP3NN1-3E device as a new clinical study for blood pressure measurement accuracy was deemed unnecessary. For the predicate device, this detail is absent from the provided text.

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

This is not applicable. The device described is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers or comparative effectiveness studies of the type described.

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

Yes, a standalone evaluation of the device's performance is implied. The document states that the "Microlife Wrist Watch Blood Pressure Monitor, Model BP3NN1-3E is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique". The performance is based on the device's algorithms and hardware, without requiring human interpretation for the primary blood pressure measurement task.

7. The Type of Ground Truth Used

For blood pressure measurement devices, the ground truth for clinical accuracy studies (such as those done for the predicate device) typically involves simultaneous measurements by trained observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer or validated electronic reference device), following a rigorous protocol (like the ANSI/AAMI/ISO 81060-2 standard).

8. The Sample Size for the Training Set

This information is not provided. The document does not discuss a "training set" in the context of machine learning. The device uses an "oscillometric method" with "measurement algorithm and its program codes" which, while involving signal processing, is described as a "well-known technique" rather than a system trained on a specific dataset in the modern AI sense.

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

This information is not provided as the concept of a "training set" in the context of an AI/machine learning model is not explicitly discussed for this device. The underlying oscillometric method and algorithms would have been developed and validated over time based on physiological principles and empirical data, but not necessarily through a formal "training set" with established ground truth as understood in current AI development.

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The Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X 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 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.

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 Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X is designed to measure 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 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".

The device has Irregular Heartbeat Detection (IHD) function. It detects the appearance of irreqular heartbeat during measurement and the irreqular heart beat symbol " is displayed on the LCD screen if any irregular heart beat signal has been detected. In addition, 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 with the PC via USB cable.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X.

Based on the provided document, the device did not undergo specific clinical testing for its overall accuracy and performance for this particular submission (K141083). Instead, the submission relies on the "substantial equivalence" principle to predicate devices. Therefore, direct acceptance criteria and study data for this specific model as if it were a novel device are not present in the given text.

The document claims that the device's measurement algorithm and program codes from a predicate device (BP3BS1-3C) remain unchanged, and therefore its performance in terms of blood pressure measurement would be identical. This means the clinical performance data would refer to those predicate devices, not the BP3NU1-4X directly.

However, I can extract information relevant to the type of testing and standards that would typically apply to such a device, and how the manufacturer justifies not conducting new clinical trials for this specific model.

Acceptance Criteria and Study for Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X

Important Note: The provided document states that no new clinical testing was necessary for the Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X because its fundamental scientific technology, measurement algorithm, and program codes are identical to a predicate device (Model BP3BS1-3C). Therefore, the "reported device performance" in the table below reflects the performance expected based on the predicate device, or general expectations for such devices, rather than new, specific performance data for Model BP3NU1-4X itself.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Clinical Performance Test Set: No new clinical test set was used for the BP3NU1-4X device itself, specifically for blood pressure measurement accuracy. The justification for substantial equivalence is based on the performance of a predicate device (BP3BS1-3C). The document does not specify the sample size or data provenance for the original clinical studies performed on the predicate device.
• Non-Clinical Testing: The non-clinical tests (reliability, EMC) were conducted on the BP3NU1-4X device. The sample sizes for these engineering tests are not specified but are typically sufficient to demonstrate compliance with the respective standards.

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

• Not applicable for the BP3NU1-4X directly, as new clinical testing was not performed. For the predicate device, clinical validation (e.g., against ANSI/AAMI SP10) would typically involve qualified clinicians taking reference measurements (e.g., auscultatory readings by trained observers) to establish ground truth. The document does not provide details on these experts for the predicate testing.

4. Adjudication method for the test set

• Not applicable as new clinical testing was not performed for the BP3NU1-4X. In a typical clinical validation for a blood pressure monitor, multiple trained observers often take reference readings, and their agreement (or specific adjudication rules) would be used to establish the validated ground truth.

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 an automated blood pressure monitor, not an AI-assisted diagnostic imaging device requiring human reader intervention.

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

• Yes, implicitly. The blood pressure measurement algorithm operates autonomously without human intervention during measurement. The justification for substantial equivalence relies on the standalone performance of this algorithm, which remains "unchanged" from the predicate device. The accuracy testing required by standards like ANSI/AAMI SP10 is a standalone performance evaluation of the device's measurement capabilities against a reference standard.

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

• For the blood pressure accuracy (referencing the predicate device's clinical validation), the ground truth would typically be established by simultaneous auscultatory measurements performed by trained human observers using a mercury sphygmomanometer or another validated reference device, following standardized protocols (e.g., specified by ANSI/AAMI SP10).
• For non-clinical tests, ground truth is the specified engineering requirement or standard for the test (e.g., specific voltage levels for EMC, impact force for drop tests).

8. The sample size for the training set

• Not applicable. This device is likely using a fixed algorithm based on established oscillometric principles, not a machine learning model that requires a distinct "training set" in the conventional sense. The "training" or development of the algorithm would have occurred during the initial design of the oscillometric method, likely incorporating physiological models and experimental data, but this is not disclosed as a separate dataset in this submission.

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

• Not applicable for the same reasons as (8). Any data used for the development of the oscillometric algorithm would have been associated with reference measurements (e.g., auscultatory) to optimize the algorithm's accuracy, but this is part of the fundamental technology development, not a separate "training set" for an AI model in this context.

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The Microlife Wrist Watch Blood Pressure Monitor, Model BP3BS1-3C 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 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.

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 with the PC via USB cable.

Microlife Wrist Watch Blood Pressure Monitor, Model BP3BS1-3C is designed to measure systolic and diastolic blood pressure, 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 pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The device has an 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 irreqular heart beat signal has been detected. In addition, 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 with the PC via USB cable.

The device being reviewed is the Microlife Wrist Watch Blood Pressure Monitor, Model BP3BS1-3C.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for the clinical performance testing of the modified device.
• Data Provenance: The document states that the modified device (BP3BS1-3C) did not undergo new clinical testing because it is "identical" in technical aspects and measurement algorithm to the predicate device (BP3MK1-3). Therefore, the clinical performance data would be derived from the studies supporting the predicate device, but the specifics of those studies (e.g., country of origin, retrospective/prospective nature) are not provided in this document.

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

• Not Applicable. No new clinical study was performed for the modified device to establish ground truth for blood pressure measurements. Clinical testing for blood pressure monitors typically involves comparison to a reference standard (e.g., sphygmomanometer measurements by trained observers), not expert consensus in the same way an imaging AI might.

4. Adjudication Method for the Test Set

• Not Applicable. As no new clinical test set was used for the modified device, there was no adjudication method described.

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

• No. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers. There is no mention of an MRMC study.

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

• Yes, effectively. The performance of the device's blood pressure measurement algorithm is assessed against a standard (ANSI/AAMI SP10: 2008), which represents standalone performance. The document explicitly states that "the measurement algorithm and its program codes of BP3BS1-3C remain unchanged," implying its standalone performance maintains equivalence to the predicate device.

7. The Type of Ground Truth Used

• Reference Standard Measurements (for predicate device): For blood pressure monitors conforming to standards like ANSI/AAMI SP10, the ground truth for blood pressure measurements is established by trained observers using a reference standard method (e.g., auscultatory method with a mercury sphygmomanometer). While not detailed for this specific submission, it's inferred from the standard adherence.

8. The Sample Size for the Training Set

• Not Applicable / Not provided. Blood pressure monitors using the oscillometric method are based on established physiological principles and algorithms, rather than training a machine learning model on a "training set" in the conventional sense of AI. The algorithm for the device "remains unchanged" from its predicate, which indicates it's a fixed, established algorithm.

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

• Not Applicable / Not provided. As mentioned above, this isn't a machine learning device that requires a training set and corresponding ground truth in the same way an AI diagnostic algorithm would. The algorithm's development (for the predicate device) would have been based on physiological models and empirical data, but not a "training set" in the modern AI context.

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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 Wrist Watch Blood Pressure Monitor, Model BP3BU1-4U is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the wrist.

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 Microlife Wrist Watch Blood Pressure Monitor, Model BP3BU1-4U is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressures is similar to the auscultatory method but uses an electronic semiconductor pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic, diastolic and calculating pulse rate is a well known technique in the market called the "oscillometric method". 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 provided text describes a 510(k) premarket notification for a blood pressure monitor and does not contain detailed information about acceptance criteria or specific study results that would typically be associated with AI/ML-based medical devices or comparative effectiveness studies. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical and some clinical aspects, but not in the way an AI-based device's performance would be evaluated.

However, based on the information provided, here's an attempt to extract and infer relevant details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to the ANSI/AAMI SP10-2002 National Standard for Manual, Electronic or Automated Sphygmomanometers. This standard would define the acceptance criteria for blood pressure measurement accuracy. While the specific numerical criteria are not detailed in the provided text, typically these standards involve criteria for mean difference and standard deviation between the test device and a reference measurement.

Important Note: The document 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 means the performance data provided is for the predicate device (BP3BU1-5), not the new device (BP3BU1-4U), and the assumption is that the modification (addition of PC-link function) did not impact the clinical performance related to blood pressure measurement accuracy.

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

• Test Set Sample Size: Not explicitly stated for the clinical evaluation. The document only mentions that the predicate device (Microlife Wrist Watch Blood Pressure Monitor, Model BP3BU1-5) underwent testing according to ANSI/AAMI SP10-2002. Standards like ANSI/AAMI SP10 typically require a minimum number of subjects (e.g., 85 subjects for validation).
• Data Provenance: Not specified (e.g., country of origin). The study for the predicate device would have been prospective to adhere to the ANSI/AAMI standard.

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

• Number of Experts: Not explicitly stated. The ANSI/AAMI SP10 standard for blood pressure monitor validation typically requires at least two independent trained observers to perform auscultatory reference measurements.
• Qualifications of Experts: Not specified in the document, but for compliance with ANSI/AAMI SP10, these would be clinical professionals (e.g., physicians, nurses, or trained technicians) who are proficient in auscultatory blood pressure measurement.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly detailed. For ANSI/AAMI SP10, if multiple observers are used, their readings are compared, and specific protocols are followed to handle discrepancies (e.g., averaging their readings if within a certain threshold, or rereading if outside the threshold). This isn't a typical "adjudication" in the sense of consensus for image interpretation, but rather a methodology for obtaining a reliable reference measurement.

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

• No MRMC study was done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases. Therefore, the concept of a human reader improving with AI vs. without AI assistance is not applicable here.

6. Standalone Performance Study:

• Yes, a standalone performance study was done for the predicate device. The clinical testing according to ANSI/AAMI SP10-2002 is a standalone performance study of the device's accuracy in measuring blood pressure compared to a reference standard. The document states, "The BP3BU1-4U met all relevant requirements of this standard, as applicable to our modified device," indicating that the predicate device's standalone performance satisfied the standard.

7. Type of Ground Truth Used:

• Expert Consensus of Auscultatory Measurements. For blood pressure monitors, the ground truth (reference method) is typically obtained through skilled clinical professionals performing auscultatory measurements using a mercury sphygmomanometer (or an appropriately validated non-mercury reference device) simultaneously or sequentially with the test device, following standardized protocols outlined in ANSI/AAMI SP10.

8. Sample Size for the Training Set:

• Not Applicable / Not Provided. This device uses the "oscillometric method," which is a well-known technique. While it involves a software algorithm, the document does not suggest an AI/ML model that requires a "training set" in the modern sense (i.e., for supervised learning with data-driven model training). The algorithm is described as a "well known technique," implying a predetermined, fixed algorithm rather than one developed through machine learning.

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

• Not Applicable. As explained above, there's no indication of a machine learning "training set" in the conventional sense for this device. The algorithm likely relies on established physiological principles and signal processing techniques for oscillometric blood pressure determination.

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The Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U with semiconductor pressure sensor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the wrist.

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 Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressures is similar to the auscultatory method but uses an electronic semiconductor pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic, diastolic and calculating pulse rate is a well known technique in the market called the "oscillometric method". 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 provided 510(k) summary for the Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U, focuses on demonstrating substantial equivalence to a predicate device (Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1, K#040002) rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the modified device. The key takeaway is that the clinical performance of the modified device is addressed by relying on the predicate device's compliance with the ANSI/AAMI SP10-2002 standard.

Here's an attempt to extract and synthesize the requested information based on the provided text, noting where information is not explicitly available for the modified device's clinical performance:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document 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 means the reported clinical performance refers to the predicate device's performance against the ANSI/AAMI SP10-2002 standard. Specific numerical performance metrics (e.g., mean difference, standard deviation) for blood pressure accuracy as per the AAMI standard are not provided in this summary for either the predicate or the modified device.

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

• Sample Size for Clinical Performance (Predicate Device): Not explicitly stated in the provided text for the clinical study that proved compliance with ANSI/AAMI SP10-2002.
• Data Provenance: Not explicitly stated for any clinical study. The summary focuses on non-clinical and technical tests for the modified device, and refers to clinical testing performed on the predicate device.

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

• For Clinical Performance (Predicate Device): Not specified in the provided text. The ANSI/AAMI SP10 standard typically involves comparison against mercury sphygmomanometry performed by trained observers, but the number and qualifications of these observers are not detailed here.
• For Non-Clinical Tests (Modified Device): No experts were involved in establishing ground truth for the non-clinical and technical tests (reliability, EMC, PC-link software).

4. Adjudication Method for the Test Set

• For Clinical Performance (Predicate Device): Not specified. Standard practice for AAMI SP10 validation involves specific procedures for comparing automated readings against auscultatory readings, often involving multiple observers, but the adjudication method (e.g., 2+1, 3+1) is not explicitly detailed.
• For Non-Clinical Tests (Modified Device): Not applicable. These tests are objective pass/fail based on engineering specifications.

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

• No such study was performed. This type of study is not relevant to a blood pressure monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool for interpretation by human readers.

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

• Yes, in essence. The blood pressure monitor itself is a standalone device that provides measurements via its internal algorithm. The "oscillometric method" is an algorithm. The clinical testing of the predicate device against the ANSI/AAMI SP10-2002 standard essentially represents a standalone performance evaluation of the device's algorithm against a recognized standard reference method (auscultatory measurement).

7. The Type of Ground Truth Used

• For Clinical Performance (Predicate Device): The ground truth for blood pressure measurement against the ANSI/AAMI SP10-2002 standard would typically be auscultatory blood pressure measurements performed by trained observers using mercury sphygmomanometers. This is generally considered an "expert consensus" or "reference standard" method in this context.
• For Non-Clinical Tests (Modified Device): The ground truths were engineering specifications and functional requirements (e.g., successful data transfer for PC-link).

8. The Sample Size for the Training Set

• Not applicable / Not specified. The device uses the "oscillometric method," which is a well-known, established algorithm, not typically "trained" in the sense of modern machine learning models with large datasets. If there were any algorithmic refinements based on data, the size of that data is not mentioned in the summary.

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

• Not applicable / Not specified. As noted above, the "oscillometric method" is a long-established technique. The summary does not describe a machine learning training process.

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The Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 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 Microlife Wrist Watch Blood Pressure Monitor BP3AX1 is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique with an inflatable cuff wrapped around wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor pressure sensor instead of a stethoscope and uses an electronic convention to define the systolic, diastolic and electrical signals, by analyzing those signals. The method for calculating pulse rate is a well known technique in the market and is the so called "oscillometric method".

The provided text describes the Microlife Blood Pressure Monitor Model BP3AX1 and its 510(k) submission. However, it does not contain a detailed table of acceptance criteria, reported device performance metrics, or a comprehensive study report with the specific information requested in your prompt (e.g., sample sizes for test/training sets, ground truth establishment details, MRMC study results, etc.).

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Microlife Wrist Watch Automatic Blood Pressure Monitor, Model BP-3BU1-5, K# 021305) and lists the non-clinical and clinical tests performed at a high level.

Here's what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that the device "met all relevant requirements" of AAMI SP10-1992. However, it does not provide the specific numerical acceptance criteria (e.g., mean difference, standard deviation limits) or the actual measured performance data (e.g., 2.3 mmHg ± 5.6 mmHg) from the clinical study. Similarly, for non-clinical tests, it only states "None of the testing demonstrated any design characteristics that violated the requirements" and "the relevant requirements...were met," without providing specific pass/fail criteria or quantitative results.

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

• Sample Size for Test Set: Not specified. The document mentions that ANSI/AAMI SP10-1992 testing was performed, but does not provide the number of subjects or measurements included in this clinical validation.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a clinical validation study for a blood pressure monitor, it would typically be prospective.

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 applicable/Not specified. For a blood pressure monitor, "ground truth" during clinical validation is typically established by trained human observers using a mercury sphygmomanometer simultaneously or sequentially with the automated device on the same subject, following a standardized protocol like AAMI SP10. The document does not specify the number or qualifications of these human observers.

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

Not specified. The document does not describe any specific adjudication method for discrepancies during the clinical testing. For AAMI SP10, there are specific requirements for agreement between observers, but the details of implementation are not provided 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

Not applicable. This device is an automated blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve "human readers" or "AI assistance" in the sense of image interpretation or complex clinical decision support. Therefore, an MRMC study and effect size for human readers improving with AI are not relevant to this type of device.

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

Yes, effectively. The "standalone" performance here refers to the device's ability to accurately measure blood pressure on its own. The clinical testing against the ANSI/AAMI SP10-1992 standard is a standalone performance evaluation of the automated device against a reference standard (typically a trained human observer using a mercury sphygmomanometer). The results state that "All relevant sections were met," indicating its standalone performance was deemed acceptable.

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

The ground truth for the clinical study would have been established by trained human observers using a reference standard (e.g., auscultation with a mercury sphygmomanometer), as prescribed by the ANSI/AAMI SP10-1992 standard. This is the accepted method for validating automated blood pressure devices.

8. The sample size for the training set

Not applicable/Not specified. This is an oscillometric blood pressure monitor, not a machine learning or AI-based device that typically requires a distinct "training set" in the context of model development. The algorithm for oscillometric measurement is well-established, and its "training" would be more akin to calibration and design refinement rather than statistical model training. If any internal data was used for initial algorithm development or parameter tuning, it is not disclosed as a "training set" here.

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

Not applicable/Not specified. As mentioned above, a "training set" in the context of machine learning is not directly applicable here. The fundamental principles of oscillometric measurement are physics-based, and calibration procedures would rely on traceable pressure standards, not "ground truth" derived from clinical data in the same way an AI model's training data would be established.

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