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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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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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WA400 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)

AA300 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, and then transferred to the other data memory media through USB connection port 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 wrist type/model WA400 and upper arm type/model AA300. The main intended use for these two type of blood pressure monitor is as the description of the following section:

In addition to the main blood pressure and heart beat rate measuring function, the WA400 and AA300 blood pressure monitors provide also the memory function for user to store the result of measurement. AA300 also provides the USB connection port for the transformation of measuring data.

The provided text does not contain detailed information about a study that proves the device meets specific acceptance criteria beyond stating compliance with voluntary standards and software verification. There is no mention of a clinical trial with a defined test set, ground truth establishment, or expert involvement. The submission appears to rely on substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested details cannot be extracted from the given information.

However, based on the provided text, we can infer some general acceptance criteria and the nature of the "study" that supports substantial equivalence.

Inferred Acceptance Criteria and Reported Performance (Based on Substantial Equivalence and Compliance to Standards):

Details Not Available in the Provided Text:

• Sample size used for the test set and the data provenance: Not explicitly stated. The "verification and validation tests" are mentioned but no specifics about the test set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no independent expert-based ground truth establishment for a test set is described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no adjudication process is mentioned for defining ground truth.
• 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: Not applicable, as this is a blood pressure monitor, not an AI-assisted diagnostic imaging device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone blood pressure monitor (algorithm only performance essentially). However, the "study" described is about establishing equivalence to a predicate, not necessarily a de novo clinical performance study against a reference standard.
• The type of ground truth used: Not explicitly stated for a performance study. For substantial equivalence, the "ground truth" is implied to be the performance and safety characteristics of the predicate device as established by its clearance and adherence to standards like ANSI/AAMI SP 10-2002.
• The sample size for the training set: Not applicable, as there's no mention of a machine learning model being "trained" in the context of this traditional medical device. The "measuring software" used the Oscillometric method, which is a well-established algorithm, not typically "trained" on a dataset in the modern AI sense.
• How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary of the "Study" (Based on the 510(k) Summary):

The core "study" proving the device meets acceptance criteria is primarily a substantial equivalence comparison to two predicate devices (Zen Strong models ZSBP-001 and ZSBP-101, both cleared under K070473).

The key elements of this "study" are:

1. Comparison of Intended Use: Demonstrated that the WA400 and AA300 have the same intended use as their respective predicate devices.
2. Comparison of Technical Characteristics: Asserted that the WA400 and AA300 share similar technical characteristics with their predicates.
3. Compliance with Voluntary Standards: Stated that the devices comply with ANSI/AAMI SP 10-2002, EN 60601-1, and EN 60601-1-2. These standards typically define accuracy requirements and testing protocols for blood pressure monitors.
4. Software Verification: Confirmed that software verification was carried out according to FDA guidance.
5. Verification and Validation Tests: General mention of "verification and validation tests" to demonstrate that any engineering differences do not affect intended use or alter fundamental scientific technology, thus maintaining the same safety and effectiveness as the cleared predicate devices. No details about the specific methodology, sample sizes, or results of these tests are provided in this summary.

In essence, the "study" is a justification that the new devices are so similar to already cleared devices that they can be presumed safe and effective without requiring a full de novo clinical effectiveness trial. The acceptance criteria are therefore largely met by demonstrating adherence to recognized performance standards (like ANSI/AAMI SP 10-2002) and functional equivalence to the predicates.

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