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The Upper Arm Type Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult by using the arm cuff (22-42cm), it can be used in medical facilities or at home. It is supplied for OTC use.

The proposed device, Upper Arm Type Blood Pressure Monitor, is a battery or AC adaptor driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at wrist within its claimed range and accuracy via the oscillometric technique. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2. The proposed device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use. The proposed blood pressure monitor includes 2 models, which are F1701T, F1701TA. All models follow the same software, measurement principle and NIBP algorithm. The main difference is the deflation valve.

The provided text describes the clinical testing performed for the Upper Arm Type Blood Pressure Monitor (models F1701T and F1701TA) to verify its accuracy according to ISO 81060-2:2018.

Here's an organized breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

(The document states "The results of this clinical investigation show that the required limits for mean error and standard deviation are fulfilled by the subject device F1701T in the group of 90 adult subjects...")

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

• Sample Size: 90 adult subjects (60 male and 30 female)
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical investigation" or "clinical testing," which typically implies prospective data collection for the purpose of the study.

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

This information is not provided in the given text. For blood pressure monitor accuracy studies per ISO 81060-2, the ground truth is typically established by trained observers (often two) using a reference sphygmomanometer, not a panel of experts. The text mentions "designate individual(s)" performed the activities, but their number or qualifications aren't specified beyond being "trained."

4. Adjudication Method for the Test Set

This information is not explicitly detailed in the given text. For ISO 81060-2 studies, ground truth measurements are usually obtained simultaneously from a reference device by trained observers, and discrepancies typically require a pre-defined adjudication protocol (e.g., repeating measurements, or a third observer if two disagree beyond a certain threshold). However, the specific method used here (e.g., 2+1, 3+1, none) is not mentioned.

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 the standalone accuracy of the device against a reference method, not on human reader performance with or 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 study evaluated the accuracy of the device (F1701T) in measuring blood pressure and pulse rate, which is an assessment of the algorithm's performance without human interpretation or intervention in the measurement process itself. The "human-in-the-loop" in such a context would typically refer to a human reading and interpreting the oscillometric waveform, which is not how automated devices operate. The device itself performs the measurement and provides the reading.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by comparison with a reference standard (human-obtained measurements from a reference sphygmomanometer) as required by ISO 81060-2 for non-invasive sphygmomanometers. While the document doesn't explicitly state "reference sphygmomanometer," this is the standard practice for clinical validation against the ISO 81060-2 standard.

8. The Sample Size for the Training Set

The document does not provide information about the sample size for any training set. Blood pressure monitors using oscillometric techniques typically use pre-established algorithms derived from engineering principles and validation against reference methods, rather than machine learning models that require a separate, large training set in the typical sense.

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

Since no specific training set or machine learning approach is mentioned, the document does not describe how ground truth for a training set was established. The overall accuracy of the device's measurement algorithm would have been developed and validated through extensive engineering and prior testing, ultimately leading to the clinical validation study described.

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