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The Microlife Upper Arm Blood Pressure Monitor, Model WatchBP Home (BP3MX1-1) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm.

The device can be used in connection with your personal computer (PC) running the WatchBP 1.0 software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.

Microlife Upper Arm Automatic Blood Pressure Monitor, Model WatchBP Home is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive 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 has and measurement mode. In additional, the device can be used in connection with your personal computer (PC) running the WatchBP 1.0 software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home (BP3MX1-1):

Summary of Acceptance Criteria and Device Performance

The submission states that the device was tested against the ANSI/AAMI SP10-2002 standard for sphygmomanometers. The core of their argument is that no new clinical study was performed for the subject device because it is "technically identical" to a predicate device (Model BP3BT0-A) in terms of its blood pressure measurement algorithm and software. Therefore, the performance of the predicate device is directly transferable.

Based on the provided text, a specific table of acceptance criteria and reported device performance for the subject device isn't explicitly laid out in a distinct table format within the 510(k) summary. Instead, the general statement is made:

• "The WatchBP Home met all relevant requirements of this standard, as applicable to our modified device."

This implies that the acceptance criteria are those defined by the ANSI/AAMI SP10-2002 standard, and the device's reported performance (by extension of its predicate) met them. Without the specific details of AAMI SP10-2002 contained within this document, a detailed table cannot be created. However, for the purpose of this exercise, we can infer the acceptance criteria are adherence to the standard, and the reported performance is compliance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text for a new clinical study. The submission explicitly states that new clinical testing for the WatchBP Home device was not necessary because its performance is considered identical to a predicate device (Model BP3BT0-A). Therefore, any sample size would relate to the predicate device's original testing, which is not detailed here.
• Data Provenance: Not applicable for new clinical data concerning the subject device, as no new clinical study was conducted. The reasoning for this is based on the technical and algorithmic identity to a predicate device.

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

• Not applicable, as no new clinical study was performed for the subject device. The ground truth for the predicate device's clinical testing would likely have involved auscultatory measurements by trained professionals, but these details are not provided in this document.

4. Adjudication Method for the Test Set

• Not applicable, as no new clinical study was performed for the subject device.

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

• No, a MRMC comparative effectiveness study was not done for the subject device. The submission relies on the technical equivalence to a predicate device.

6. Standalone Performance (i.e. algorithm only without human-in-the loop performance)

• Yes, a standalone performance assessment was effectively done, albeit indirectly, through the claim of technical identity to the predicate device. The device's measurement algorithm, which operates autonomously, is the core component being evaluated for compliance with the AAMI standard. The human-in-the-loop aspects (like irregular heartbeat detection or specific measurement modes) are described as differences, but the fundamental blood pressure measurement algorithm is stated as unchanged.

7. Type of Ground Truth Used

• For the original predicate device (BP3BT0-A) that the assessment relies upon, the ground truth would typically be established by simultaneous auscultatory measurements performed by trained observers, as per the ANSI/AAMI SP10 standard. This standard often requires comparison against sphygmomanometers using the auscultatory method.

8. Sample Size for the Training Set

• Not applicable. The oscillometric algorithm itself would have been developed and "trained" (in a broader sense, meaning optimized and validated) in prior stages, likely using extensive clinical data. However, the specific training set size for the algorithm underlying this device is not provided. The submission focuses on the validation against a standard rather than the developmental training of the algorithm.

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

• Not applicable for a new training set. If referring to the original development of the oscillometric algorithm, the ground truth would have been established through a combination of simultaneous auscultatory measurements and potentially invasive arterial pressure measurements in clinical studies, used to correlate and optimize the oscillometric readings. These details are not within the scope of this 510(k) summary.

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