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HD 3161 Blood Pressure Monitor is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.

This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to be 9.44 to 16.9 inches (24cm〜43cm).

HD 3161 Blood Pressure Monitor measures both systolic and diastolic blood pressure and heart pulse rate via a standard oscillometric method. The oscillometric method senses the vibrating signal via the closed air pipe system and utilizes a microcomputer to automatically sense the characteristics of the pulse signal. Unlike with the traditional measuring method, based on the Korotkov sound, with the oscillometric method the use of a stethoscope is not required. Through simple calculations, this method provides accurate blood pressure readings: the systolic pressure is defined as the blood pressure when the cuff pressure oscillating amplitude begins to increase, while the diastolic blood pressure is defined as the pressure when the cuff pressure oscillating amplitude stops decreasing.

The provided document is a 510(k) premarket notification for the BioCare Asia HD 3161 Blood Pressure Monitor. It presents a comparison of the proposed device with a predicate device, the U-RIGHT TD-3127 Blood Pressure Monitoring System (K100658), to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly uses the predicate device's performance as the acceptance criteria for most metrics, aiming for substantial equivalence. The key performance criteria for blood pressure monitors are accuracy and measurement range.

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

The document mentions "PERFORMANCE & CLINICAL TEST" under IEC 80601-2-30:2013 and AAMI / ANSI / ISO 81060-2:2013. However, it does not explicitly state the sample size used for any clinical test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature) for any clinical study mentioned. It only indicates that these tests were performed and passed.

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

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications for any clinical test. For blood pressure monitors, ground truth is typically established by trained technicians or clinicians using a reference invasive or non-invasive method.

4. Adjudication Method for the Test Set:

The document does not provide any information about the adjudication method used for any clinical test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is not typically applicable to a standalone blood pressure monitor, which directly measures physiological parameters rather than requiring human interpretation of medical images or data.

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

Yes, the regulatory submission is for a standalone device (the HD 3161 Blood Pressure Monitor). Its performance, as demonstrated by meeting the listed standards, is a standalone performance validation. The device itself performs the measurement and provides the readings without needing human interpretation of the underlying signal for the final blood pressure value.

7. The Type of Ground Truth Used:

While not explicitly detailed, for blood pressure monitor validation according to standards like AAMI/ANSI/ISO 81060-2, the ground truth is typically established through simultaneous or near-simultaneous measurements by a validated reference method, often using auscultation by trained observers (using a stethoscope and sphygmomanometer) or sometimes invasive arterial pressure monitoring in specific clinical settings. The document implies that the device's accuracy was compared against such a standard in the "PERFORMANCE & CLINICAL TEST."

8. The Sample Size for the Training Set:

The product is a blood pressure monitor that uses an oscillometric method. This method usually involves pre-programmed algorithms based on physiological principles and validated against clinical data. The document does not specify a "training set" sample size in the context of machine learning, as this device does not appear to be an AI/ML product in the sense of continuously learning from a vast dataset. Instead, its accuracy is validated against established medical device performance standards.

9. How the Ground Truth for the Training Set was Established:

As explained in point 8, the concept of a "training set" in the context of machine learning is generally not applicable here. The fundamental algorithms for oscillometric blood pressure measurement are based on established physiological understandings and bioengineering principles. The "ground truth" for the development and validation of these algorithms would historically have involved extensive clinical studies comparing oscillometric readings to direct intra-arterial measurements or meticulous auscultatory readings. The document implies that the device's design and fixed algorithm adhere to the principles validated by the predicate device and the relevant international standards (IEC 80601-2-30:2013, AAMI / ANSI / ISO 81060-2:2013).

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