(67 days)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office ABI (TWIN200 ABI) is a device intended to measure the systolic and diastolic blood pressure, pulse rate and calculate Pulse Pressure (PP), Mean Arterial Pressure (MAP) and Ankle Brachial Index (ABI) of an adult individual by using a non-invasive oscillometric technique in one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s) and one inflatable cuff is wrapped around the ankle.
The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.
The device can be used in connection with your personal computer (PC) running the WatchBP Analyzer Office ABI 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 WatchBP Office ABI (TWIN200 ABI) is designed to measure systolic and diastolic blood pressure, pulse rate and calculate Pulse Pressure (PP), Mean Arterial Pressure (MAP) and Ankle Brachial Index (ABI) of an individual by using a non-invasive technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s) and one inflatable cuff is wrapped around the ankle. 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, Pulse Pressure (PP), Mean Arterial Pressure (MAP) and Ankle Brachial Index (ABI), which is a well - known technique in the market called the "oscillometric method".
The device has >, > and > measurement modes and has atrial fibrillation detection function, inflation pressure setting function, measurement intervals setting function etc. In addition, the device can be used in connection with your personal computer (PC) running the WatchBP Analyzer Office ABI software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable.
The > mode is selected to complete fully-automated triple measurements on both arms according to recommended ESH/AHA blood pressure measurement protocols for a patient's first office visit.
The > mode is selected to perform automated triple measurements on the preferred arm for prompt and accurate office measurements.
The > mode is selected for Ankle Brachial Index pressure measurement. Select the lateral with the higher blood pressure value according to the measurement result of > mode.
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.
The provided text describes a 510(k) summary for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office ABI (TWIN200 ABI). While it details the device, its intended use, and comparisons to predicate devices, it does not contain information about specific acceptance criteria, study methodologies for proving device performance against these criteria, or detailed clinical study results and ground truth establishment for a machine learning model.
The document explicitly states:
"The subject modified device Model WatchBP Office ABI (TWIN200 ABI) is from the technical point of view, identical to the blood pressure monitor Model WatchBP Office (Twin200). The differences between them do not relate to blood pressure measurement technology so the clinical accuracy in terms of blood pressure detection will not be affected. Therefore repeated clinical testing in accordance with ANSI/AAMI SP10 is therefore not required."
This means that a new clinical study specifically proving the accuracy of this modified device's blood pressure measurement was not deemed necessary because the core measurement technology was considered unchanged from a previously cleared device. The focus of the 510(k) submission is on demonstrating substantial equivalence based on non-clinical tests (Reliability, EMC, Safety, Software Validation) and the functional additions (ABI calculation, atrial fibrillation detection, PC connectivity).
Therefore, it is not possible to extract the requested information regarding acceptance criteria, study design for proving performance, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these details are not present in the provided text. The document states that clinical testing for blood pressure accuracy was "not required."
If you have a document that details the clinical validation of a blood pressure monitor, or a device that uses a trained algorithm (e.g., for AI/ML features), I would be able to answer your questions using that information.
§ 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).