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The Electronic Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adults via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 ~32 cm.

The electronic blood pressure monitor uses fuzzy logic intelligence to detect both upper and lower pressure value simultaneously. The personalized optimal inflation level determines the result of each measurement. It is effective to reduce the discomfort by wrongly inflating the CUFF and also to reduce the wrong measurement value, thus, it improves the accuracy of the measurement. The device would store 99 groups of measurement values for 2 users and display the average reading of the latest 3 groups of measurement results. The device is composed of a main body and a cuff. The main body is composed of a central processing unit, a pressure sensor, an air pump, a solenoid valve, a uniform speed vent valve, a PCB board, and a LCD liquid crystal display.

The provided text is a 510(k) summary for an Electronic Blood Pressure Monitor. It does not contain specific acceptance criteria or detailed study results in a format that lends itself to a direct table of acceptance criteria and reported device performance with numerical values for metrics like sensitivity, specificity, or accuracy (beyond general $\pm 3$ mmHg for static pressure and $\pm 5%$ for pulse rate).

However, I can extract the relevant information regarding the study and ground truth methodologies used to demonstrate substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states compliance with international standards, which implicitly define the acceptance criteria. Specific numerical performance data beyond accuracy statements for static pressure and pulse rate are not provided in this summary.

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

The document mentions clinical testing was conducted per ISO 81060-2: 2013. However, it does not specify the sample size used for this clinical test set, nor the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for the clinical validation. For blood pressure monitors, the "ground truth" during clinical validation typically involves simultaneous or sequential measurements by trained observers using mercury sphygmomanometers (or other validated reference devices), rather than "experts" in the sense of radiologists reviewing images.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. In the context of blood pressure monitor validation, this wouldn't typically involve adjudication among multiple human readers as seen in imaging studies, but rather statistical comparison of device measurements against reference measurements.

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

No. This is a blood pressure monitor, not an imaging device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study of human readers with vs. without AI assistance is not applicable and was not performed.

6. Standalone (Algorithm Only) Performance Study

Yes, implicitly. The clinical validation per ISO 81060-2: 2013 is a standalone performance study. This standard outlines procedures for validating automated non-invasive sphygmomanometers, meaning the device's measurements are directly compared against reference measurements without human interpretation or in-the-loop assistance for the primary measurement function. The device's "algorithm" is the core oscillometric technique it employs to derive blood pressure.

7. Type of Ground Truth Used

The clinical validation per ISO 81060-2: 2013 standard typically uses reference measurements obtained from auscultation by trained observers using mercury sphygmomanometers or other validated reference devices as the "ground truth." The document implies that the standard was followed for clinical testing, suggesting this type of ground truth was used.

8. Sample Size for the Training Set

This device is an Electronic Blood Pressure Monitor based on an oscillometric technique with "fuzzy logic intelligence" for inflation. While it uses "intelligence" (fuzzy logic), it's not described as a deep learning or AI model that requires a "training set" in the conventional sense of machine learning for image classification or complex pattern recognition. The "fuzzy logic" likely refers to rule-based or empirically derived algorithms rather than data-driven machine learning models. Therefore, the concept of a "training set" in the context of large datasets for deep learning is not applicable or mentioned for this device.

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

As explained above, a "training set" in the machine learning sense is not applicable to the description of this device. The "fuzzy logic" would have been developed and refined through engineering and empirical testing against reference measurements, but not through a formal "training set" with established ground truth as seen in AI/ML applications.

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