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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP O3 (BP3MZ1-1) 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 03 software .The memory data can be transferred to the PC by connecting the monitor with the PC via USB cable.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP 03 (BP3MZ1-1) is designed to measure systolic and diastolic blood pressure, 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 auscuitatory method but uses an electronic 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 modes and has a medication record function. In addition, the device can be used in connection with your personal computer (PC) running the WatchBP O3 software. The memory data can be transferred to the PC by connecting the monitor with the PC via USB cable.

The provided text describes a 510(k) submission for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP O3 (BP3MZ1-1). This submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study for the new device. The key argument for equivalence in terms of blood pressure measurement accuracy is that the new device uses the identical measurement algorithm and program codes as the previously cleared predicate device, Model WatchBP Home (BP3MX1-1).

Therefore, the acceptance criteria and study information reference the standard applied to the predicate device because the accuracy of the new device is asserted to be the same due to identical core technology for measurement.

Here's the breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary primarily references adherence to the ANSI/AAMI SP10: 2002 standard for blood pressure monitors. The document explicitly states that the WatchBP O3 (BP3MZ1-1) met all relevant requirements of this standard, as applicable to our modified device. As the core measurement technology is identical to the predicate, the performance is implicitly equivalent to the predicate's performance against this standard. Specific numerical performance data for the WatchBP O3 (BP3MZ1-1) itself is not provided, rather it relies on the predicate's established performance.

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

• Sample Size for Test Set: Not explicitly stated for the WatchBP O3 (BP3MZ1-1) clinical testing. The submission states that "Repeat clinical testing in accordance with the standard ANSI/AAMI SP10 for the subject WatchBP O3 (BP3MZ1-1) device is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device." This implies reliance on the clinical data for the predicate device, Model WatchBP Home (BP3MX1-1), which would have undergone testing according to this standard. ANSI/AAMI SP10 typically requires a minimum of 85 subjects for validation.
• Data Provenance: Not specified in the provided text, as the focus is on the claim of identical performance to a previously cleared device. If the predicate's study was used, its provenance would apply.

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

• Number of Experts: Not specified. For AAMI SP10 validation, ground truth is typically established by trained human observers using a mercury sphygmomanometer, often with two or more observers simultaneously to reduce bias, but their "expert" status is primarily based on training rather than specific years of experience in the way a radiologist's experience might be cited.
• Qualifications of Experts: Not specified. Standard practice for AAMI SP10 validation involves trained observers (often nurses or other medical professionals) following a strict protocol for auscultatory measurements.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified directly for the device, as clinical testing was deemed unnecessary due to identical core technology. For AAMI SP10 validation, if multiple ground truth observers are used, their readings are typically averaged or differences adjudicated according to the standard's protocol for comparing to the automated device. The standard aims for high inter-observer agreement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study comparing human readers with and without AI assistance is not relevant for a blood pressure monitor, which is a standalone measurement device rather than an AI diagnostic aid for human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Yes, a standalone study was effectively done for the predicate device, which forms the basis for the current device's performance claim. The "oscillometric method" described is an algorithm-only measurement that does not require human intervention during the measurement process to determine systolic and diastolic blood pressure. The WatchBP O3 (BP3MZ1-1) is stated to have the "measurement algorithm and its program codes... unchanged" from the predicate, implying its standalone performance is identical to the predicate device's standalone performance, which met the ANSI/AAMI SP10: 2002 standard.

7. The Type of Ground Truth Used

• Expert Consensus (Auscultation): For blood pressure monitors, the gold standard (ground truth) is typically human auscultatory measurement using a mercury sphygmomanometer, often performed by multiple trained observers, from which an "expert consensus" or averaged reading is derived. This is the method prescribed by ANSI/AAMI SP10.

8. The Sample Size for the Training Set

• Not applicable / Not specified. Blood pressure monitors using the oscillometric method are often developed using a combination of engineering principles, signal processing, and empirical data, but there isn't a "training set" in the machine learning sense as would be relevant for an AI algorithm that learns complex patterns from labeled data. The algorithm is based on a well-established physiological principle rather than being "trained" on a dataset in the modern AI paradigm.

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

• Not applicable. See explanation for #8. The "ground truth" during the development of traditional oscillometric algorithms would involve physiological understanding and calibration against known reference methods, but not a "training set" with ground truth in the AI sense.

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