(202 days)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor,Model WatchBP O3 (BP3SZ1-1) is a non-invasive 24 hour ambulatory blood pressure monitor (ABPM) using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for or use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm.
The device can accurately measure in pregnant patients including those with known or suspected preeclampsia.
The device provides aortic blood pressure parameters, includes central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff.
The device detects the appearance of atrial fibrillation during measurement and gives a warning signal together with the measured blood pressure value if atrial fibrillation is detected.
The memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth.
The device is intended to be used by healthcare professionals and patient's environments.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP O3 (BP3SZ1-1) is designed to measure systolic and diastolic blood pressure, pulse rate, and mean arterial pressure (MAP) of the adults and pediatrics (but not neonates) populations with arm circumference sizes ranging from 14 -52 cm by using a noninvasive 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 a resistive pressure sensor rather than a stethoscope and mercury manometer. The sensor 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, mean arterial pressure (MAP), central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic pressure (cDBP) which is a well - known technique in the market called the "oscillometric method".
The device is a 24 hour ambulatory blood pressure monitor (ABPM) .It's selected for fully programmable 24-hour patient out-of-office blood pressure measurement, the device automatically takes measurements at fixed intervals programmed by the physician.
The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.
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.
In addition, the memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth.
The device is intended to be used by healthcare professionals and patients in clinical and patient's environments.
The medical device referenced is the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP O3 (BP3SZ1-1).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood pressure monitors generally follow established standards such as ISO 81060-2. While the exact numerical criteria aren't explicitly stated in a table format within the provided document, the text mentions compliance with ISO 81060-2:2018 for clinical validation. This standard outlines the accuracy requirements for intermittent automated measurement types of non-invasive sphygmomanometers.
Reported Device Performance:
The document states that the clinical validation reports for the subject device, following ISO 81060-2:2018, demonstrate the accuracy of blood pressure measurement in the general population across a wide range of arm sizes and for ambulatory blood pressure monitoring (VOL 10, 002 and VOL 10, 003).
Additional performance features and claims for which the device's accuracy is asserted (by leveraging predicate device validation or by implication of compliance with standards) include:
- Accurate measurement in pregnant patients, including those with known or suspected pre-eclampsia.
- Detection of atrial fibrillation.
- Measurement of aortic blood pressure parameters (cSBP, cPP, cDBP).
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Blood Pressure Measurement Accuracy (as per ISO 81060-2:2018 for intermittent automated measurement type) | Clinical validation reports of the subject device following ISO 81060-2:2018 demonstrate the accuracy of the blood pressure measurement for use in the general population across a wide range of arm sizes (VOL 10, 002). |
| Accuracy for Ambulatory Blood Pressure Monitoring (ABPM) | Clinical validation reports for the subject device intended for ambulatory blood pressure monitoring (VOL 10, 003) demonstrate its accuracy for this use. |
| Ability to accurately measure in pregnant patients (including those with known or suspected pre-eclampsia) | The device can accurately measure in pregnant patients, including those with known or suspected pre-eclampsia (stated in Indications for Use and the clinical validation section leverages the predicate's validation for this). The performance of the WatchBP O3 (BP3SZ1-1) in terms of brachial blood pressure measurement in pregnant patients would be essentially equivalent with the predicate device. |
| Atrial Fibrillation Detection | The device detects the appearance of atrial fibrillation during measurement and gives a warning signal. The performance of the WatchBP O3 (BP3SZ1-1) in terms of atrial fibrillation detection would be essentially equivalent with the predicate device. |
| Measurement of Aortic Blood Pressure Parameters (cSBP, cPP, cDBP) | The device provides aortic blood pressure parameters, including central systolic blood pressure (cSBP), central pulse pressure (cPP), and central diastolic blood pressure (cDBP), non-invasively. The performance of the WatchBP O3 (BP3SZ1-1) in terms of central blood pressure measurement would be essentially equivalent with the predicate device. |
| Safety and Essential Performance (as per IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 10993 series, AAMI/ANSI/IEC 80601-2-30, IEC 60601-1-11) | Non-clinical testing was conducted to prove safety and effectiveness as well as substantial equivalence, utilizing national and international standards listed (e.g., IEC 60601-1, IEC 60601-1-2, ISO 14971, AAMI/ANSI/ISO 10993 series, AAMI/ANSI/IEC 80601-2-30, IEC 60601-1-11). It was concluded that the device met all relevant requirements of these tests. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the clinical test sets. It refers to "clinical validation reports of the subject device following ISO 81060-2:2018 for use in general population across a wide range of arm sizes (VOL 10, 002) and intended for ambulatory blood pressure monitoring (VOL 10, 003)".
The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the given text. For non-invasive blood pressure monitors, the ground truth for accuracy studies is typically established by trained observers taking auscultatory measurements using a mercury sphygmomanometer, not usually by "experts" in the sense of physicians establishing diagnoses. The methodology of ISO 81060-2:2018 would dictate the number and training of these observers.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly mentioned. For blood pressure measurement validation studies, ground truth is typically established by simultaneous measurements or sequential measurements by multiple trained observers, with specified acceptable differences between their readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable and was not conducted as this is a device for automated measurement of blood pressure, not an imaging or diagnostic AI system requiring human reader interpretation. Thus, the concept of "how much human readers improve with AI vs without AI assistance" does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary clinical validation conducted falls under a standalone performance evaluation. The device is an "Automatic Digital Blood Pressure Monitor" using an "oscillometric technique." The clinical validation according to ISO 81060-2:2018 assesses the accuracy of the device's automated measurements against a reference standard (typically auscultatory measurements). This evaluates the algorithm's performance directly, as it automatically determines systolic and diastolic blood pressure, pulse rate, MAP, cSBP, cPP, cDBP, and atrial fibrillation detection.
7. The Type of Ground Truth Used
For the blood pressure measurement accuracy (ISO 81060-2:2018), the ground truth is established by a reference standard measurement, typically simultaneous auscultatory measurements performed by trained observers using a mercury sphygmomanometer or equivalent, as per the standard's protocol.
For the atrial fibrillation detection, the ground truth would likely be established by a reference ECG recording interpreted by a cardiologist, although this specific detail is not provided.
8. The Sample Size for the Training Set
The document describes this as a premarket notification for a predicate device. It explicitly states that the subject device (BP3SZ1-1) uses "the same software algorithm to determine the systolic and diastolic blood pressure, pulse rate, mean arterial pressure (MAP), central systolic blood pressure (cSBP) and central diastolic pressure (cDBP), central pulse pressure (cPP) and Atrial Fibrillation Detection" as the predicate device (BP3SK1-3B). This indicates the algorithm was already developed and validated with prior data, likely from the predicate device's development or other studies that are not mentioned in this submission.
Therefore, the sample size for a "training set" for the algorithm itself is not provided in this document, as the focus is on clinical validation of the device using an existing algorithm.
9. How the Ground Truth for the Training Set Was Established
As stated above, the document doesn't provide information on the training set for the algorithm. However, given that the algorithm is the "same" as a predicate device, its original ground truth would have been established through a similar process of comparing automated blood pressure readings against reference standard auscultatory measurements (for blood pressure) and likely expert-adjudicated ECGs (for AFib detection) during its development and initial validation.
§ 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).