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WA100/WA200/WA300/WB100/WB200/WD100/WE100/WF100 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel and kept in the memory for home care use( without the involvement of professional physician)

AA100/AA200/AB100/AC100/AD100 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel, kept in the memory for home care use( without the involvement of professional physician)

Basically the measuring system were composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software ... and so on.

The main operation for the blood pressure measurement is carried out in such a way that the measuring cuff at arm is inflated to the estimated pressure level, then deflated to zero automatically. During the inflation and deflation, the pressure change with respective of time were recorded as the data base of measurement. Then the following measuring results will be calculated against the measurement data base :

• Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method)
• Heart beat rate.

For this submission, two different type of blood pressure monitors are to be included in this 510(K) submission, the W series wrist type/model WA100/WA200/WA300/WB100/ WB200/WD100/WE100/WF100 and A series upper arm type/model AA100/AA200/ AB100/AC100/AD100.

In addition to the main blood pressure and heart beat rate measuring function, the W series wrist type/model WA100/WA200/WA300/WB100/WB200/ WD100/WE100/WF100 and A series upper arm type/model AA100/AA200/AC100/AC100/AD100 blood pressure monitors provide also the memory function for user to store the result of measurement.

The provided 510(k) summary for the Diaier Blood Pressure Monitor does not contain a detailed study report with specific acceptance criteria and performance data for the device itself. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices (Diaier model WA400 (K091553) for wrist type and Diaier model AA300 (K091553) for upper arm type).

The document states that "verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared devices." However, the specifics of these tests, including acceptance criteria and reported device performance with numerical data, are not provided in this summary.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here's an attempt to answer the questions based on the available information and highlighting what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Summary of Device and Performance Claim:
The Diaier Blood Pressure Monitors (W series for wrist, A series for upper arm) automatically measure human systolic and diastolic blood pressure and heart rate using the oscillometric method. The primary claim for these devices is that they maintain the same safety and effectiveness as their predicate devices (WA400 and AA300 respectively).

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The summary only mentions "verification and validation tests contained in this submission," implying internal testing.

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

• Number of Experts: This information is not provided.
• Qualifications of Experts: This information is not provided. For blood pressure monitors, ground truth is typically established by trained clinical personnel (e.g., physicians, nurses) using a reference sphygmomanometer following a recognized protocol (e.g., those outlined in ANSI/AAMI SP10).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This information is not provided. For blood pressure accuracy studies, adjudication would typically involve multiple observers for the reference measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids where human readers interpret medical images or data. The Diaier Blood Pressure Monitor is a direct measurement device and does not involve human "readers" or AI assistance in a diagnostic capacity.

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

• Yes, performance testing would inherently be standalone (algorithm only) for a blood pressure monitor. The device itself performs the measurement and calculation of blood pressure and heart rate without human intervention during the measurement process. The primary study type would be a clinical accuracy study comparing the device's readings to directly measured or auscultatory reference values. Details of such a study are not provided in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• While not explicitly stated, for blood pressure monitors, the ground truth is typically established through simultaneous or near-simultaneous measurements by trained observers using a validated reference method (e.g., auscultatory method with a mercury or aneroid sphygmomanometer). This is a form of expert reference measurement rather than consensus, pathology, or outcomes data.

8. The sample size for the training set:

• This information is not applicable / not provided. Blood pressure monitors using the oscillometric method are based on established physiological principles and algorithms, not typically on machine learning models requiring large "training sets" in the conventional AI sense. The algorithms are usually developed and validated through engineering and clinical trials directly.

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

• This information is not applicable / not provided for the same reasons as #8. The algorithms are developed based on physiological models and extensive testing to derive the relationship between oscillations and blood pressure values.

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