(24 days)
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.
| Acceptance Criteria (Inferred from ANSI/AAMI SP10-2002) | Reported Device Performance |
|---|---|
| Mean difference between device and reference for systolic blood pressure (SBP) ≤ 5 mmHg | "BP3BU1-4U met all relevant requirements of this standard, as applicable to our modified device." (No specific numerical performance reported) |
| Standard deviation of difference between device and reference for SBP ≤ 8 mmHg | "BP3BU1-4U met all relevant requirements of this standard, as applicable to our modified device." (No specific numerical performance reported) |
| Mean difference between device and reference for diastolic blood pressure (DBP) ≤ 5 mmHg | "BP3BU1-4U met all relevant requirements of this standard, as applicable to our modified device." (No specific numerical performance reported) |
| Standard deviation of difference between device and reference for DBP ≤ 8 mmHg | "BP3BU1-4U met all relevant requirements of this standard, as applicable to our modified device." (No specific numerical performance reported) |
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.
§ 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).