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

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

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

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

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

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GX1-5X (BP A3 PC) is designed to measure systolic and diastolic blood pressure, pulse rate of an adult individual with arm circumference sizes ranging from 22 -52 cm by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The device detects the appearance of irregular heartbeat during measurement. and the symbol is displayed after the measurement. In addition, the memory data can be transferred to the PC (personal computer) running the Microlife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable.

The device is also validated for patients with diabetes mellitus.

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

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

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

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

Acceptance Criteria and Device Performance for Diabetic Patients

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

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

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

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

For each pressure (systolic and diastolic):

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

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

Study Details (Specifically for Diabetic Patients Validation):

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

1. Table of acceptance criteria and reported device performance:

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

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

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

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

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

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

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

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a validation study for an automated blood pressure monitor, not a diagnostic imaging AI system involving human readers. Therefore, an MRMC study is not applicable here.

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

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

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

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

8. The sample size for the training set:

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

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

   • As stated above, this question is not applicable as there is no training set in the context of an adaptive AI model. The device's algorithm for determining systolic and diastolic pressure is described as one that "converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the 'oscillometric method'". The algorithm itself is pre-programmed, not learned from data in the field.

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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-4A (BP A200 Comfort) is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual with arm circumference sizes ranging from 14 -52 cm by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the single upper arm.

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

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

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-4A (BP A200 Comfort) 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 uses a 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 symbol " memory data can be transferred to the PC (personal computer) running the Microlife Blood Pressure Analyzer (BPA) software by connecting the monitor via cable.

The provided FDA 510(k) summary for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-4A (BP A200 Comfort) includes information about clinical validation testing. However, it does not provide all the specific details requested regarding acceptance criteria, reported performance, and the full methodology of the study.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that a clinical validation was conducted in accordance with ISO 81060-2. This standard defines the accuracy requirements for automated non-invasive sphygmomanometers. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between device and reference measurements) are not explicitly stated in this summary, they are implicitly those outlined in ISO 81060-2.

The summary states: "Results were passing and the subject device was found to be substantially equivalent to the predicate device." This indicates that the device met the acceptance criteria defined by ISO 81060-2 for blood pressure measurement accuracy.

Therefore, for the table:

• Mean difference between device and reference: ≤ ±5 mmHg
• Standard deviation of differences: ≤ 8 mmHg
  (These are examples from ISO 81060-2 and might not be the exact numbers used or reported if different versions of the standard apply, but the device must meet some such criteria) | "Results were passing" |
  | Irregular Heartbeat Detection Accuracy (if applicable in ISO 81060-2 for this device type) | "The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected." (No specific accuracy metrics reported here, but functionally stated as working) |

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

The document does not explicitly state the sample size used for the clinical validation in accordance with ISO 81060-2.

• Sample Size: Not explicitly stated. ISO 81060-2 typically requires a minimum number of subjects (e.g., 85 subjects with specific demographic and blood pressure distribution).
• Data Provenance: Not explicitly stated. The document doesn't mention the country of origin of the data or whether it was retrospective or prospective. Clinical validation studies for device clearance are almost always prospective.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth.

• ISO 81060-2 typically requires measurements by multiple trained observers (e.g., at least two) to establish reference blood pressure readings using a standardized auscultatory method. These observers must be highly trained and follow strict protocols. Their qualifications are usually medical professionals with specific training in blood pressure measurement.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method.

• In clinical validation according to ISO 81060-2, the reference blood pressure is typically determined by two independent observers. If there is a significant discrepancy between their readings, a third observer might be used, or the readings might be discarded. This can be considered a form of 2-or-3 observer consensus for ground truth establishment rather than a formal "adjudication" in the AI sense.

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

No. An MRMC comparative effectiveness study is not mentioned or described. The clinical validation appears to be a standalone accuracy study of the device against a reference method, not a comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes. The clinical validation study described is a standalone performance study of the device (which includes its algorithm) against a reference method (auscultatory blood pressure measurement according to ISO 81060-2). The summary focuses on the device's ability to accurately measure blood pressure.

7. Type of Ground Truth Used

The ground truth for blood pressure measurement in this context is established by expert auscultatory measurements (often referred to as a "reference standard" or "gold standard") carried out by trained observers according to strict protocols defined by standards like ISO 81060-2.

8. Sample Size for the Training Set

The document describes the submission as a 510(k) for a medical device that uses an "oscillometric method" with an algorithm to define systolic and diastolic blood pressure. It states the device "uses the same algorithm" as a predicate device. This implies the algorithm was already developed and potentially refined using historical data.

However, the summary does not provide any information about the sample size used for training this underlying algorithm. This information is typically not included in a 510(k) summary unless the AI/ML algorithm itself is novel and part of the substantial equivalence claim, requiring specific validation of its training pipeline. In this case, it appears the algorithm is considered established.

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

Since no training set information is provided, how its ground truth was established is also not documented in this 510(k) summary. For a blood pressure algorithm, the training set would ideally consist of blood pressure recordings (oscillometric waveforms) paired with simultaneously taken auscultatory reference measurements.

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