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WA100WA200MA300/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 types of blood pressure monitors are to be included in this 510(K) submission, the W series wrist type/model WA100/WA200/WD100/WE100/WF100/WB200 and A series upper arm type/model AÁÍ00/AA200/AD100/AC100/AF100/AE100/AC200/AC300.

In addition to the main blood pressure and heart beat rate measuring function, the W series wrist type/model WA100/WA200WA300/WB100/WB200/ WD100/WE100/WF100 and A series opper arm type/model AA100/AA200/AB100/AC100/AD100 blood pressure monitors provide also the mpen an function for user to store the result of measurement.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Ningbo Diaier Electronic Co., Ltd. Blood Pressure Monitor:

Disclaimer: The provided 510(K) summary and correspondence focus heavily on substantial equivalence to predicate devices and compliance with voluntary standards (like ANSI/AAMI SP 10-2002). It does not contain detailed information about specific acceptance criteria or the full study protocol/results in the manner typically presented for clinical trials or performance studies of diagnostic algorithms. The information below is extracted directly from the provided text, and where details are missing, it is noted.

Acceptance Criteria and Device Performance

The core of the acceptance criteria appears to be compliance with established voluntary standards for blood pressure monitors, specifically ANSI/AAMI SP 10-2002. This standard sets benchmarks for accuracy and other performance aspects of automated sphygmomanometers. While the specific numerical acceptance criteria from ANSI/AAMI SP 10-2002 are not explicitly stated in the document, compliance with this standard implies that the device meets those established criteria.

Table of Acceptance Criteria and Reported Device Performance (Based on provided text)

Note on Reported Device Performance: The document states "Compliance to applicable voluntary standards includes ANSI/AAMI SP 10-2002." This is a general statement of compliance, not a presentation of the numerical performance results (mean difference, standard deviation, etc.) that would typically be reported from a validation study against the standard. The study (or "discussion of non-clinical tests") is presented as demonstrating this compliance.

Study Details

The provided text describes the "Discussion of Non-Clinical Tests Performed" as the basis for determining substantial equivalence. This "study" primarily consists of testing for compliance with voluntary standards.

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

   • Test Set Sample Size: Not explicitly stated in the provided text. ANSI/AAMI SP 10-2002, which the device claims compliance with, typically dictates specific subject numbers for clinical validation (e.g., at least 85 subjects with specific age and BP ranges). However, the document does not break down the number of subjects used for this specific submission's testing.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given the company is Chinese, the testing likely occurred in China, but this is an inference, not stated fact. The phrasing "discussion of non-clinical tests performed" suggests prospective testing done for the purpose of this submission.

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

   • Number of Experts & Qualifications: Not explicitly stated. For validation against ANSI/AAMI SP 10-2002, at least two trained observers (experts in auscultatory measurement) are required for reference BP measurements, typically using a mercury sphygmomanometer or validated equivalent. The qualifications would include specific training and demonstrated proficiency in auscultatory blood pressure measurement. The document implies that such standard procedures were followed by claiming compliance to the standard.

3. Adjudication method for the test set:

   • Adjudication Method: Not explicitly stated. For ANSI/AAMI SP 10-2002, the reference blood pressure is typically the average of the two expert observers' measurements, provided they are within a specified agreement. If not, a third expert or repeat measurement might be involved, but details are not provided here.

4. 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:

   • MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids where human interpretation is involved. This device is a standalone blood pressure monitor, not an AI assistance tool for human interpretation.

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

   • Standalone Performance: Yes, the testing described (compliance with ANSI/AAMI SP 10-2002) is a standalone performance test. It evaluates the device's accuracy in measuring blood pressure and heart rate without human intervention influencing the measurement process itself, other than proper application of the cuff and initiation of the device.

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

   • Ground Truth: The ground truth for blood pressure measurement, as per ANSI/AAMI SP 10-2002, is typically established by simultaneous auscultatory measurements performed by trained observers using a calibrated reference device (like a mercury sphygmomanometer). This can be considered a form of "expert measurement" or "reference standard measurement."

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable/not stated. As a standalone diagnostic device based on an Oscillometric method, it's not a machine learning model that undergoes "training" in the sense of a deep learning algorithm requiring a separate training set. The device's algorithm would have been developed and validated internally, but the concept of an external "training set" as understood for AI is not present here.

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

   • Training Set Ground Truth Establishment: Not applicable, as there isn't a "training set" in the context of an AI/ML algorithm. The device's internal algorithms would have been developed and refined using internal methods and potentially reference data, but this is part of product development, not a separate "training set ground truth" for regulatory submission.

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