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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 13.5cm to 21.5cm in home and hospital facilities by using a non-invasive oscillometric technique. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Weony Digital Blood Pressure Monitor WBP Series are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual (at least 12 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory 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 main components of the Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 135 and 215 mm, includes the inflatable bladder and PU shell. All models of the wrist blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, and the LCD. The subject devices are powered by two AAA alkaline batteries or adatpter.

The device has irregular heart beat (IHB) indicator which compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over a specified range.

This document describes the FDA 510(k) clearance for the Digital Blood Pressure Monitor WBP Series (K231542) by Weony (Shenzhen) Technology Co., Ltd. The information provided focuses on demonstrating substantial equivalence to predicate devices, particularly regarding performance and accuracy.

Here is an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The primary acceptance criteria for blood pressure monitors is typically defined by the ISO 81060-2 standard for clinical validation of automated measurement type. This standard specifies limits for the difference between the device's measurements and reference measurements. The document states the device was tested against this standard and the results show the accuracy is "within acceptable scope specified in ISO 81060-2."

While the document references the standard for acceptance, it does not provide a specific table of numerical acceptance criteria alongside the actual reported device performance (e.g., mean difference and standard deviation). However, the "SE Comparison" table includes:

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: 85 patients (41 males and 44 females)
• Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer is Weony (Shenzhen) Technology Co., Ltd. in China, and the study was likely conducted in China. The study was a prospective clinical validation as it involved patients participating in a new study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that a "manual Mercury Sphygmomanometer was used as a reference device" for ground truth. It does not mention the number of experts or their qualifications for establishing this ground truth. Typically, for such studies, trained clinical personnel (e.g., doctors, nurses) would perform the manual measurements.

4. Adjudication method for the test set

The document does not describe any specific adjudication method for the test set. The ground truth was established by direct comparison to a manual mercury sphygmomanometer.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not conducted. This refers to studies where multiple human readers assess cases with and without AI assistance. The device is a direct measurement device (blood pressure monitor), not an AI-assisted diagnostic imaging tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the primary clinical validation described is a standalone performance study. The device, as an automated non-invasive sphygmomanometer, inherently performs its measurements and calculations without human intervention in the core measurement process. The study validates the device's accuracy against a gold standard (manual mercury sphygmomanometer).

7. The type of ground truth used

The ground truth used was reference measurements from a manual Mercury Sphygmomanometer.

8. The sample size for the training set

The document does not specify a separate "training set" sample size. For medical devices like blood pressure monitors, the validation typically involves extensive bench testing and a clinical validation study (as described) rather than a machine learning "training set" in the conventional AI sense. If there was any internal algorithm development or calibration, the data used for that is not detailed.

9. How the ground truth for the training set was established

As there's no explicitly mentioned "training set" in the AI sense, this information is not applicable. The device's underlying "algorithm" is the oscillometric method, which is a well-established physiological principle, not a machine learning model that requires a distinct, labeled training dataset from scratch. The performance is validated through the clinical study against a gold standard.

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The device intended to measure the diastolic, systolic blood pressures and pulse rate for adult population in home and hospital facilities by using a non-invasive oscillometric technique with a single upper arm cuff (22-36 cm). The device detects the appearance of irregular heats during measurement and gives a warning signal with readings.

Weony Digital Blood Pressure Monitor WBP Series are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual (at least 18 or above) 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 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 main components of the Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 360 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, and the LCD. The subject devices are powered by four AA alkaline batteries or adatpter.

The device has irreqular heart beat (IHB) indicator which compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over a specified range.

The provided text describes the 510(k) summary for the Digital Blood Pressure Monitor WBP Series. It details the device, its intended use, comparison to a predicate device, and the non-clinical and clinical tests performed to support substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and study proving adherence to them:

1. A table of acceptance criteria and the reported device performance

The primary standard for clinical validation of automated non-invasive sphygmomanometers, ISO 81060-2:2018, sets the acceptance criteria for accuracy.

2. Sample size used for the test set and the data provenance

• Sample Size: 85 patients (47 males and 38 females)
• Data Provenance: Not explicitly stated, but the submission is from a Chinese manufacturer (WEONY (SHENZHEN) TECHNOLOGY CO., LTD.), so it is highly probable the data was collected in China. The text does not specify if the study was retrospective or prospective, but clinical validation studies for device approval are almost always prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth for blood pressure measurements in this context is established by a reference method, not by individual experts' interpretation of images or other subjective data.

• Reference Method: "The manual Mercury Sphygmomanometer was used as a reference device."
• Number of Experts/Operators: While not explicitly stated, clinical validation of automated sphygmomanometers according to ISO 81060-2 typically requires measurements by trained observers using the reference method. The standard mandates specific procedures for these measurements to ensure accuracy and minimize bias, often involving at least two trained observers taking simultaneous or sequential measurements. The document does not specify the number or qualifications of these observers.

4. Adjudication method for the test set

• Adjudication Method: "Same arm sequential method was adopted during the clinical testing." This indicates a direct comparison of the device's reading against the reference standard on the same arm, likely following strict protocols to minimize errors. This isn't an "adjudication" in the sense of resolving conflicting expert opinions, but rather a direct comparison to a gold standard.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This device is a blood pressure monitor, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting data with or without AI assistance. The study is a direct clinical validation of the device's accuracy against a known reference standard (manual mercury sphygmomanometer).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, in spirit. The device itself is an automated system based on the oscillometric method. Its primary function is to measure blood pressure without direct human interpretation of raw signals; humans only read the displayed results. The clinical study validates the performance of this automated algorithm in measuring blood pressure. However, the term "standalone" usually refers to AI algorithms in diagnostic contexts. In this case, the device essentially functions as a "standalone" measurement system.

7. The type of ground truth used

• Expert Consensus / Reference Standard: The ground truth was established using a manual Mercury Sphygmomanometer, which is considered the gold standard (or a highly accurate reference method) for blood pressure measurement in clinical validation studies. The measurements taken with this reference device are performed by trained personnel, effectively serving as an "expert consensus" or highly accurate reference.

8. The sample size for the training set

• Not applicable. This document describes the validation of a traditional medical device (blood pressure monitor) that operates on an established oscillometric principle, not an AI/machine learning model that would require a separate "training set" and "test set" in the conventional sense. The device's algorithm is based on well-understood physiological principles and signal processing, not on learning from a large dataset.

9. How the ground truth for the training set was established

• Not applicable. As stated above, this device does not utilize a machine learning model that requires a "training set" with ground truth established for learning. Its operational principles are fixed and based on physics and established medical techniques.

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