(209 days)
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:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).