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The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm).

The device detects the appearance of irregular heart beats during measurement and gives a warning signal with readings.

The Subject device is not intended to be diagnostic device.

Combei Blood Pressure Monitor are 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 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 420 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, Bluetooth tranismiision (optional) and the LCD. The subject devices are powered by four AA alkaline batteries or adatpter. The device also 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 irreqular pulse rhythm when the difference of the time intervals is over a specified range.

The provided document contains information about the acceptance criteria and study that proves the device meets the acceptance criteria. Here's a summary of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states compliance with ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. This standard outlines the acceptance criteria for blood pressure monitor accuracy. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between the device and reference for systolic and diastolic blood pressure) are not explicitly detailed in the provided text, the document indicates that the results showed the accuracy of the blood pressure monitor is "within acceptable scope specified in ISO 81060-2."

From the "SE Comparison" table, the reported device accuracy is:

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

• Sample size for the test set: 85 patients
• Data provenance: Not explicitly stated, but the study was conducted as a "clinical investigation" for regulatory submission, implying prospective data collection. The manufacturer is Shenzhen Combei Technology Co., Ltd. from China, so the study was likely conducted in China.

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

The document mentions that "The manual Mercury Sphygmomanometer was used as a reference device" and that a "Same arm sequential method was adopted during the clinical testing." For non-invasive sphygmomanometer validation studies following ISO 81060-2, ground truth is typically established by trained observers using a reference manual sphygmomanometer. However, the exact number of experts/observers and their specific qualifications (e.g., radiologist with 10 years of experience) are not provided in this document.

4. Adjudication method for the test set:

The document states "Same arm sequential method was adopted during the clinical testing" using a manual Mercury Sphygmomanometer as a reference. This method involves taking simultaneous or sequential measurements by both the device under test and the reference method. For validation against ISO 81060-2, typically multiple observers take readings, and their readings are often averaged or adjudicated for the reference measurement. However, the specific adjudication method (e.g., 2+1, 3+1, none) is not explicitly detailed in the provided text.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on validating the accuracy of the automated blood pressure monitor against a manual reference standard, not on comparing human readers with and without AI assistance.

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

Yes, a standalone study was done. The clinical investigation described in section 8 (Brief discussions of clinical tests) evaluates the automated blood pressure monitor's performance directly against a reference device, without human interpretation of the device's output influencing the measurement. It's an algorithm-only (device-only) performance evaluation.

7. The type of ground truth used:

The type of ground truth used was measurements from a manual Mercury Sphygmomanometer, which serves as the reference standard for blood pressure measurement in accordance with ISO 81060-2.

8. The sample size for the training set:

The document does not provide information on the sample size for the training set. The clinical study mentioned (85 patients) is for validation/testing, not for training the algorithm. As a medical device that measures blood pressure using well-established oscillometric principles, it's possible that the core algorithm does not rely on a large, distinct "training set" in the same way a machine learning-based diagnostic algorithm would, or that such training data was internal to development and not disclosed in the 510(k) summary.

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

As no information is provided on a training set, the method for establishing its ground truth is also not mentioned.

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The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff (size: 2232cm(8.712.6in) is wrapped around the single upper arm. The Subject device is not intended to be diagnostic device.

The Subject device is battery driven automatic non-invasive Blood Pressure Monitor. It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique. The Automatic Upper Arm style utilizes an inflatable cuff that is wrapped around the upper arm; the cuff circumference is limited to: 22cm32cm (8.7in12.6in).

The document is a 510(k) Pre-market Notification for a Digital Blood Pressure Monitor. It describes the device's characteristics, intended use, and comparison to a predicate device. The clinical validation data provided is specifically for demonstrating the accuracy of the blood pressure monitor.

Here's an analysis of the provided text to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for accuracy are based on ISO 81060-2:2013, which specifies the requirements for clinical validation of automated non-invasive sphygmomanometers. The document states that the device's accuracy is "within acceptable scope specified in ISO 81060-2."

While ISO 81060-2 provides specific statistical criteria (mean difference and standard deviation of differences between the device and reference measurements), the document does not explicitly list these numerical criteria or the exact calculated performance metrics but rather makes a summary statement of compliance.

However, a "Substantial Equivalence Comparison" table (Table 1) provides the following for the subject device and predicate device:

Note: The accuracy characteristic listed as "Pressure: ±3mmHg; Pulse: ±5%" for the subject device seems to be a design specification or internal target, rather than reported clinical performance data resulting from the ISO 81060-2 study. The ISO standard specifies a statistical method to declare accuracy, not a simple range. The statement under section 9 "Brief discussions of clinical tests" that "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2" is the key clinical performance outcome. Without the specific numerical results (mean difference and standard deviation) from the ISO 81060-2 test, a precise performance table cannot be constructed from this document.

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

• Sample Size for Test Set: Eighty-seven (87) patients.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical investigation," which implies prospective data collection for this purpose.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

• For blood pressure accuracy studies following ISO 81060-2, "experts" in the traditional sense of image interpretation for AI are not typically involved in establishing ground truth.
• Ground Truth: The ground truth for blood pressure measurements is established by a manual Mercury Sphygmomanometer as the reference device, with measurements performed by trained personnel according to the standard. The document states: "The manual Mercury Sphygmomanometer was used as a reference device."

4. Adjudication Method for the Test Set

• Adjudication Method: The document describes a "Same arm sequential method" for the clinical testing. This is a specific protocol for comparing automated blood pressure readings to a reference standard, not an adjudication method in the context of multiple human readers for AI. It implies direct comparison of measurements taken immediately after each other.

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

• No, an MRMC comparative effectiveness study was not done. This study is for the clinical validation of a blood pressure monitor's accuracy against a standard, not an AI-assisted diagnostic device where human reader improvement would be measured.

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

• Yes, in essence. The validation described is for the device (the automated blood pressure monitor) itself, which functions as a standalone algorithm (oscillometric technique) to measure blood pressure without human interpretation of complex data (like medical images). It's comparing the device's automated readings to a reference standard.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established using a manual Mercury Sphygmomanometer as the reference device. This falls under the category of a reference standard method (a gold/silver standard where applicable) for physiological measurements.

8. The Sample Size for the Training Set

• Not Applicable/Not Provided: This document describes the clinical validation of a physical medical device (blood pressure monitor), not an AI/machine learning model where a distinct "training set" would be used for algorithm development. The device's underlying oscillometric algorithm is presumably developed and optimized by the manufacturer using internal methods, but this document does not detail that process or any "training set."

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

• Not Applicable/Not Provided: As mentioned above, this document does not refer to a training set for an AI model. The "ground truth" for the device's function is inherent in its design and the physical principles of oscillometry, calibrated and validated against established standards.

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