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The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25" – 7.75".

FORTIFIER Digital Wrist Blood Pressure Monitor, LF-01 uses the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, clinically proven, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.

The FORTIFIER Digital Wrist Blood Pressure Monitor, LF-01, is a non-invasive device designed to measure systolic and diastolic blood pressure and pulse rate in adults over 18 years old. It utilizes the oscillometric method with an inflatable wrist cuff.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria in the typical format of a table with specific targets for accuracy (e.g., mean difference and standard deviation within specific limits). However, it references the ANSI/AAMI SP10-1992 standard for "Electronic or Automated Sphygmomanometers" as the performance testing guideline. This standard defines accuracy requirements for blood pressure monitors.

While the document doesn't provide specific numerical results from the ANSI/AAMI SP10-1992 test, the fact that the device was deemed "substantially equivalent" implies that it met the performance requirements outlined in this standard.

Assumed Acceptance Criteria (based on ANSI/AAMI SP10-1992, typical for Blood Pressure Monitors):

Note: The document only states which standards were applied, not the numerical results of those tests. The "Reported Device Performance" is inferred from the FDA's substantial equivalence determination, which means the device performed comparably to safety and effectiveness to the predicate device and met the referenced standards.

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

The document does not specify the sample size used for the performance testing conducted according to ANSI/AAMI SP10-1992.
The data provenance is not explicitly stated, but since the testing was done by FORTIFIER INTERNATIONAL CO., LTD. in Taiwan, it is likely that the testing was conducted prospectively (as part of the device's development and regulatory submission) and the data originated from Taiwan or other regions where the testing laboratory operates.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth during the ANSI/AAMI SP10-1992 testing.

For blood pressure monitor validation, ground truth is typically established by trained observers (e.g., physicians or nurses) using a auscultatory method with a mercury sphygmomanometer (or an appropriately calibrated non-mercury reference device) according to a standardized protocol, often involving independent readings.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

In the context of blood pressure monitor validation, "adjudication" usually refers to a process where multiple independent readings are compared, and if discrepancies exceed a certain threshold, further review or re-measurement might be performed. The ANSI/AAMI SP10 standard outlines detailed procedures for obtaining reference brachial auscultatory measurements, which implicitly includes methods to ensure data quality, but explicit adjudication beyond those standard practices is not detailed in this submission.

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. MRMC studies are typically performed for imaging devices or AI algorithms where human interpretation is a critical component to assess improvements in diagnostic accuracy with AI assistance. This device is a standalone measurement device; therefore, an MRMC study is not applicable.

6. If a Standalone Study Was Done

Yes, a standalone study was done. The "Performance Testing" section states that the device was tested against "ANSI/AAMI SP10-1992 Electronic or Automated Sphygmomanometers," along with electrical safety and EMC reports. This implies that the device's performance was evaluated inherently as a standalone unit to meet these standards' requirements for accuracy and safety. The entire 510(k) submission itself is based on the standalone performance of the device and its substantial equivalence to a predicate device.

7. The Type of Ground Truth Used

For the ANSI/AAMI SP10-1992 standard, the ground truth for blood pressure measurements is typically established through auscultatory measurements performed by trained human observers using a standardized reference method (e.g., mercury sphygmomanometer or an equivalent validated device). This is considered the "expert consensus" or "clinical standard" for non-invasive blood pressure measurement devices.

8. The Sample Size for the Training Set

The concept of a "training set" is primarily relevant to machine learning or AI models. This device is a traditional oscillometric blood pressure monitor, not an AI-driven device. Therefore, there is no "training set" in the context of an AI algorithm. The device's internal algorithms are based on established oscillometric principles and calibration, not on a machine learning training process.

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

As noted above, there is no training set for this type of device in the AI sense. The device's oscillometric algorithms are designed based on blood pressure physiology and empirically derived models that correlate oscillation amplitude with systolic and diastolic pressures, calibrated against established reference methods. While extensive data would have been used in the development of the oscillometric method itself historically, it's not a "training set" in the context of this specific device's regulatory submission.

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