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The Wrist Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique by an inflatable cuff wrapped around the wrist at medical facilities or at home.

The Wrist Blood Pressure Monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or Kpa.

All the models included in this submission follow the the same intended use, same measurement principle, same blood pressure core algorithm and similar product design. All the models can be used with one cuff size 13.5~19.5 cm (5.3-7.7inches).

The main differences are appearance, Dimensions and some specifications which will not affect the safety and effectiveness of the device.

The provided FDA 510(k) clearance letter and associated summary pertain to a Wrist Blood Pressure Monitor, which is a medical device for measuring blood pressure and pulse rate. It is not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical acceptance criteria and study designs associated with AI/SaMD (such as multi-reader multi-case studies, ground truth establishment by experts, training set details, or effect sizes of AI assistance) are not applicable to this device.

The acceptance criteria and study details provided are tailored to the performance of a non-invasive blood pressure measurement system (hardware device), focusing on accuracy, safety, and effectiveness.

Here's a breakdown of the requested information based on the provided document, addressing the device's specific characteristics as a hardware blood pressure monitor:

Acceptance Criteria and Device Performance (Wrist Blood Pressure Monitor)

1. Table of Acceptance Criteria and Reported Device Performance

As per the 510(k) summary, the device's accuracy is a key performance metric. The acceptance criteria are based on the international standard ISO 81060-2 Third edition 2018-11 [Including AMD1:2020].

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

• Sample Size for Test Set (Clinical Accuracy Study):
  • Three groups of clinical accuracy research were conducted. Each group included 100 subjects, for a total of 300 subjects across the 13 models.
  • Group 1: 100 subjects (47 Male, 53 Female)
  • Group 2: 100 subjects (54 Male, 46 Female)
  • Group 3: 100 subjects (44 Male, 56 Female)
  • Minimum subjects for each group was 85, as per ISO 81060-2.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data. However, the manufacturer is "Shenzhen AOJ Medical Technology Co., Ltd." in Shenzhen, Guangdong, China. It is highly probable the data was collected in China.
• Retrospective or Prospective: The clinical accuracy study, designed to meet ISO 81060-2, is typically conducted prospectively to collect new data for device validation. The wording "clinical accuracy research" and "clinical accuracy test report and data analysis followed the requirements" implies a prospective study.

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

• This question is not directly applicable in the context of this device because "ground truth" for a blood pressure monitor's accuracy is established against a reference standard, not through expert consensus on interpretations of images or signals (as would be the case for AI/SaMD).
• For blood pressure monitors, the "ground truth" or reference measurement is typically taken by trained medical professionals using a standardized reference sphygmomanometer (e.g., mercurial or auscultatory method), as per the ISO 81060-2 standard. The document states "The Same Arm Sequential Method was chosen for all studies," which is a standard procedure comparison method against a reference device. The qualifications of the individuals performing these reference measurements would be trained clinicians (e.g., physicians, nurses).

4. Adjudication Method for the Test Set

• This question is not applicable for a blood pressure monitor's accuracy testing. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in human expert interpretations, especially in image-based diagnostics.
• For blood pressure accuracy, deviations are quantified statistically between the device reading and the reference measurement, not through an adjudication process among multiple "readers."

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, this was not done. This type of study is relevant for AI/SaMD devices where AI assists human interpretation and is a key component for assessing the AI's clinical utility. The Wrist Blood Pressure Monitor is a standalone hardware device that provides a measurement; it does not involve human "readers" interpreting data or AI assistance.

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

• Yes, in essence. The entire clinical accuracy study described in Section 8 ("Clinical data") evaluates the device's performance (which incorporates its internal oscillometric algorithm) in a standalone manner against a reference standard. The "algorithm" here refers to the embedded software that processes the oscillometric signals to derive blood pressure and pulse rate. The study directly assesses how accurately the device (with its integrated algorithm) measures blood pressure readings compared to the reference.
• Performance Metrics: The evaluation was based on the "mean error and standard deviation of differences for systolic, diastolic pressure" as per ISO 81060-2.

7. The Type of Ground Truth Used

• The ground truth for the clinical accuracy testing was established through concurrent measurements using a standardized reference method (e.g., auscultatory method with a mercurial sphygmomanometer or another validated reference device) on the same arm, sequentially with the test device. This is the standard for blood pressure monitor validation as per ISO 81060-2.
• It is not "expert consensus" in the sense of subjective medical interpretation, but rather an objective, standardized measurement performed by trained personnel using a calibrated reference instrument.

8. The Sample Size for the Training Set

• This concept is not applicable to this type of medical device clearance. The Wrist Blood Pressure Monitor is a hardware device with an embedded algorithm (oscillometric technique) that is based on established physiological principles. It doesn't use machine learning or deep learning in a way that requires a separate "training set" of patient data for an AI model to learn from, as would be the case for AI/SaMD devices. The device's "training" (development and calibration) would involve engineering principles and laboratory testing, rather than a data-driven machine learning process.

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

• As the concept of a "training set" in the context of machine learning is not applicable here (see point 8), the establishment of ground truth for such a set is also not applicable. The device's underlying measurement principle is well-established oscillometric technology. Development and calibration rely on physical models and engineering validation.

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The Wrist Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.

The Wrist Blood Pressure Monitor, including XY-W01B, can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with wrist circumference of 135-215mm through oscillometric method. The initial inflation pressure of the cuff is zero pressure. When start the cuff will be inflated and deflated. The Wrist Blood Pressure Monitor is composed of monitor unit and wrist cuff. Of which the monitor unit contains main control circuit board, air pump, deflation valve, LCD and shell. The two models XY-W01A and XY-W01B have the same intended use, working principle, measuring range, accuracy, cuff, and conformance standard, except for product appearance. The devices are powered by 2 AAA batteries. The Wrist Blood Pressure Monitor has a memory function that automatically stores 90 sets data of the latest measurements.

The provided text describes the acceptance criteria and the study conducted for the Wrist Blood Pressure Monitor (models XY-W01A, XY-W01B).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 120 subjects (53 female and 67 male)
• Data Provenance: The document does not explicitly state the country of origin.
• Retrospective or Prospective: Not explicitly stated, but clinical tests for device approval are typically prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. For blood pressure monitors, the "ground truth" (reference measurements) is typically established by trained technicians using a standardized auscultatory method, not necessarily by "experts" in the sense of physicians or radiologists establishing a diagnostic truth.

4. Adjudication Method

This information is not provided in the document, as it relies on direct comparative measurements rather than expert adjudication of imaging or diagnostic results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging AI systems where human readers interpret images. For a blood pressure monitor, the performance is compared against a reference measurement.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The clinical test evaluated the device's accuracy in measuring blood pressure and pulse rate against a reference standard.

7. Type of Ground Truth Used

The ground truth implicitly used is reference blood pressure measurements, likely obtained through a rigorously standardized auscultatory method as per the ISO 81060-2:2018 standard.

8. Sample Size for the Training Set

This information is not provided in the document. Given that this is a hardware device with an embedded algorithm (oscillometric technique), there isn't typically a separate "training set" in the way an AI/ML model would have for image recognition. The core algorithm's parameters are likely developed through extensive engineering and testing rather than a distinct training phase on a large dataset.

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

This information is not provided. As mentioned above, the concept of a "training set ground truth" as understood in AI/ML is not directly applicable here. The device's underlying oscillometric algorithm and its parameters would have been developed and refined through engineering principles and testing against various blood pressure profiles and body types.

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The device is intended for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.0 cm to 21.0 cm.

The Wrist Blood Pressure Monitor is a reusable, active, non-sterile, non-invasive and non-implantable device for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.0 cm to 21.0 cm. It is a home-use device prohibited from use in MRI (magnetic resonance imaging) environment. This device has the systolic and diastolic display features. The device is of the watch type and powered by a rechargeable lithium-polymer battery. An AC adapter is used for charging the device, but the device cannot be operated while charging. The device wrist cuff inflates using an integral pump, and deflates via an electric valve. During inflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 300mmHg. Product includes device (preinstalled with a strap and large-sized cuff: 16.6-21.0cm), strap with a medium-sized cuff: 13.0-16.5cm, wrist measuring tape, charging base (with the power cable). The product functional configurations of OHMS11 and OHMS12 are completely identical, and the difference between the two is reflected in the color (OHMS11 is the dark gray color, OHMS12 is the champagne color).

The provided text describes the acceptance criteria and a study for a Wrist Blood Pressure Monitor (OHMS11, OHMS12).

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 85 patients (49 males and 36 females)
• Data Provenance: Clinical study, conducted prospectively as patients "volunteered to take part in the subjects completed the clinical study." The country of origin is not explicitly stated in the provided text.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth. It mentions that "manual Mercury Sphygmomanometer was used as a reference device" and that the study followed ISO 81060-2. This standard generally requires trained observers for the reference measurements, but specific expert details are absent.

4. Adjudication method for the test set

The document states, "Same arm sequential method was adopted during the clinical testing." This indicates a specific measurement protocol where both the test device and the reference device take measurements sequentially on the same arm. There is no mention of an adjudication method involving experts for discrepancies in ground truth, as the ground truth is established by the reference device measurement.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool requiring human reader evaluation.

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

Yes, a standalone performance study was done. The clinical testing evaluates the device's accuracy (algorithm only) against a reference standard (manual mercury sphygmomanometer) without direct human intervention in interpreting the device's output. The device itself performs the measurement and provides the blood pressure readings.

7. The type of ground truth used

The ground truth used was comparison to a reference device, specifically a "manual Mercury Sphygmomanometer," following the methodology of ISO 81060-2. This is a clinical standard for validating automated blood pressure monitors.

8. The sample size for the training set

The document does not provide information regarding a training set sample size. This type of submission (510(k) for a hardware device with embedded algorithms) typically focuses on validation data rather than detailed training information for AI/ML models.

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

Since no training set information is provided, there is no information on how its ground truth would have been established. It is assumed the device relies on established oscillometric principles rather than a deep learning model requiring a large labeled training set.

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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 3/8 inches (13.5cm to 19.5cm). The device detects the appearance of irregular hearbeats during measurement and gives a warning signal with reading.

The Wrist Blood Pressure Monitor,Models: 222,222BT,W1681BL, W1681BT, W1681R are powered by a rechargable Li-ion battery, automatic, non-invasive blood pressure system intended for home use. The devices are intended for use in adult patient population with wrist circumference ranging from 5 3/8 inches to 7 2/3 inches (13.5 cm). The devices' wrist cuff inflates using an integral pump and deflates via an electric valve. During deflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 295 mmHg, and the pulse rate range from 40 to 199 beats/min.

When the device detected irregular rhythms, " W " will display on screen. An irregular heartbeat rhythm is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while your monitor is measuring blood pressure. The WHO blood pressure indicator bar can classify by WHO and ISH recommendation. The devices display the latest blood pressure reading, while up to 2 x 99 readings can be stored in memory.

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

Device Name(s): Wrist Blood Pressure Monitor (Models: 222, 222BT, W1681BL, W1681BT, W1681R)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 86 subjects.
• Data Provenance: Clinical investigation conducted by Shenzhen Cihai Hospital (China), prospective study.

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., years of experience for physicians/nurses performing the reference measurements). It states that the "auscultatory method (mercury sphygmomanometer)" was used as the reference standard, implying trained human operators.

4. Adjudication Method for the Test Set

The document states that the mean value and standard deviation of differences between the device and the mercury sphygmomanometer were calculated according to ISO 81060-2:2018. This suggests a direct comparison rather than a multi-reader adjudication process in the traditional sense for medical imaging or diagnostic algorithms. For blood pressure measurement, the reference standard (auscultatory method) intrinsically relies on trained observers.

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 MRMC comparative effectiveness study was done. This type of study is not applicable to a standalone wrist blood pressure monitor, which directly measures physiological parameters rather than assisting human readers in interpreting complex data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done for the device's accuracy in measuring blood pressure and pulse rate. The device operates independently to provide these measurements.

7. The Type of Ground Truth Used

The ground truth for the clinical accuracy study was established using the auscultatory method with a mercury sphygmomanometer, as described in ISO 81060-2:2018. This is considered a gold standard for non-invasive blood pressure measurement.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The clinical study described appears to be for validation/testing, not for training a model. Blood pressure monitors typically implement algorithms based on established physiological principles (oscillometry) and are calibrated, rather than "trained" in the machine learning sense with a distinct training dataset.

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

As no specific "training set" for an AI algorithm is mentioned in the context of the device's accuracy claims, this question is not directly applicable. The device's underlying measurement principle (oscillometric method) and its calibration would rely on established scientific and engineering practices, not on ground truth established from a training dataset in the AI sense.

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Wrist Blood Pressure Monitor is used to measure adult systolic blood pressure and pulse rate. The values are for diagnostic reference only. Suitable for medical institutions (such as hospitals, clinics, health centers, etc.) and home use.

Wrist Blood Pressure Monitor mainly consist of pressure sensor, air pump, valve, cuff, main board and plastic case. Wrist Blood Pressure Monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The radial artery in the arm changes from blocked to open as the pressure in the cuff tied around the arm changes from high to low, causing the pressure in the cuff to be superimposed on a series of small pressure pulses. The sphygmomanometer senses these signals and, after certain calculations, finds the systolic and diastolic pressures of the radial artery in the body. The Wrist Blood Pressure Monitor include two models: YJ110, YJ111

The provided text describes the non-clinical testing and a clinical validation study for a Wrist Blood Pressure Monitor (models YJ110, YJ111) to demonstrate its substantial equivalence to a predicate device (K223291).

It is important to note that the document primarily focuses on non-clinical testing (e.g., appearance, safety indices, performance indices, electrical safety, EMC, software verification) and a clinical validation study that demonstrates the accuracy of the device against a reference method, rather than a comparative effectiveness study involving human readers with and without AI assistance. The device is a blood pressure monitor, not an AI-powered diagnostic tool requiring expert interpretation of images. Therefore, some of the requested information regarding AI-specific studies (e.g., MRMC studies, expert adjudication, AI standalone performance) would not be applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a detailed table (Table VII-1) of "Inspecting item" with "Inspection content and acceptance standard" and the "Conclusion". Below is a summary, focusing on performance-related criteria:

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The Wrist Blood Pressure Monitor is intended to measure and diastolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique by an inflatable cuff wrapped around the wrist at medical facilities or at home.

AOJ-35 series wrist blood pressure monitor is designed as a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg. The device also has low voltage indication, which will be triggered when the battery is low. All the models included in this submission follow the same software, same measurement principle and same specifications. The main differences are color of the face shell and keys, which will not affect the safety and effectiveness of the device.

Here's a breakdown 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:

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

• Sample Size: 100 subjects (49 female, 51 male).
• Data Provenance: The document does not explicitly state the country of origin of the data. It is a prospective clinical study, as it was conducted "per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."

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

The document mentions that the clinical testing was conducted "per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." This standard typically outlines the requirements for validation of automated non-invasive sphygmomanometers against a reference standard. While the document doesn't explicitly state the number of experts, ISO 81060-2 typically requires measurements by trained observers using a mercury-column or auscultatory device as the reference ground truth. The qualifications of these observers would be that they are trained to accurately perform manual blood pressure measurements according to the standard. No specific details about the number or precise qualifications (e.g., "radiologist with 10 years of experience") are provided in this summary, but the reference to the ISO standard implies adherence to its requirements for ground truth establishment.

4. Adjudication Method for the Test Set:

The document does not explicitly mention an adjudication method like 2+1 or 3+1. For blood pressure validation, ISO 81060-2 typically involves simultaneous or closely timed measurements by multiple trained observers (often two) and the device under test. The differences between the device readings and the average or adjudicated readings of the observers (or a specific protocol for handling discrepancies) form the basis of the accuracy assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. The study described focuses on the standalone accuracy of the blood pressure monitor against a reference standard, not its impact on human reader performance or diagnostic accuracy.

6. Standalone Performance Study:

Yes, a standalone study (algorithm only without human-in-the-loop performance) was done. The clinical data section explicitly details the performance of the "monitor" (the device) in measuring blood pressure and pulse rate against a reference standard. The "Bench Testing" section also describes tests conducted on the device's technical performance.

7. Type of Ground Truth Used:

The ground truth used for the clinical study was established according to ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. This standard mandates a clinical validation process where the automated device's measurements are compared to measurements taken by trained observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer). This constitutes an expert-based reference standard rather than pathology or outcomes data.

8. Sample Size for the Training Set:

The document does not provide information on the sample size for the training set. This is a premarket notification for a medical device, and the focus of the provided summary is on the clinical validation (testing) and non-clinical data, not on the development or training of an AI algorithm (though the device itself likely contains algorithms, their training data is not detailed here).

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

As no training set information is provided, how its ground truth was established is not detailed in this document.

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The device are digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging form 5 3/8 inches to 7 2/3 inches (13.5cm to 19.5cm) .

The devices detect the appearance of irregular heatbeats during measurement and gives a warning signal with readings.

The Wrist Blood Pressure Monitor (model: W203,W202,W1681) are battery-powered, automatic, non-invasive blood pressure system intended for home use. The Wrist Blood Pressure Monitor (model: W203,W202,W1681) are intended for use in adult patient population with wrist circumference ranging from 5 3/8 inches to 7 2/3 inches (13.5 cm). These devices are powered by 2 X AAA battery. The device wrist cuff inflates using an integral pump and deflates via an electric valve. During inflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 295 mmHg, and the pulse rate range from 40 to 195 beats/min. When the device detected irregular rhythms, " Y " will display on screen. An irreqular heartbeat rhythm is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while your monitor is measuring blood pressure. The WHO blood pressure indicator bar can classify by WHO and ISH recommendation. The devices display the latest blood pressure reading, while up to 2) 99 readings can be stored in memory.

The provided text describes the acceptance criteria and a study proving that the device meets these criteria. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for accuracy are derived from ISO 81060-2:2013, which is referenced for the clinical study. The specific criteria are:

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

• Sample Size: Not explicitly stated. The document mentions "clinical accuracy should be checked by application of the tests of ISO 81060-2:2013, we conducted the the clinical study in accordance with this standard." ISO 81060-2 specifies subject recruitment criteria but not a fixed sample size for all studies.
• Data Provenance: Not explicitly stated. However, since Shenzhen Yuezhongxing Technology Co., Ltd. is based in China, it is reasonable to infer the data provenance is likely China, and the study was conducted to support their submission to the FDA, suggesting a prospective design for regulatory purposes.

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

This information is not available in the provided text, as the device is a blood pressure monitor, not an AI diagnostic tool requiring expert interpretation for ground truth. Blood pressure monitors establish ground truth through direct physical measurements (e.g., using a auscultatory reference method against which the oscillometric device is compared).

4. Adjudication Method for the Test Set

This information is not available in the provided text. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image analysis or subjective interpretations, which is not applicable to a blood pressure monitor's accuracy testing.

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

• Was it done? No. MRMC studies are relevant for evaluating AI systems with human interaction. This device is a standalone blood pressure monitor and does not involve human readers in the output interpretation in the manner an AI diagnostic system would.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, a standalone performance evaluation was done. The device (Wrist Blood Pressure Monitor) operates independently to measure blood pressure and pulse rate. Its accuracy was tested against established standards (ISO 81060-2:2013, which describes clinical validation of automated sphygmomanometers).

7. The Type of Ground Truth Used

The ground truth for blood pressure monitor accuracy studies typically involves:

• Simultaneous auscultatory measurements performed by trained observers (manual sphygmomanometry) as a reference method, as prescribed by standards like ISO 81060-2.
• Comparison of the device's readings against these reference measurements to determine accuracy.

8. The Sample Size for the Training Set

This information is not available in the provided text. Blood pressure monitors, especially those using oscillometric methods, are typically designed based on physics and signal processing principles rather than extensive machine learning "training sets" in the modern AI sense. While there might be internal development and calibration data, it's not described as a "training set" like in deep learning models.

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

This information is not available in the provided text, and the concept of a "training set" and "ground truth" in that context is not directly applicable to a traditional blood pressure monitor as it would be for an AI-powered diagnostic device. Device calibration and validation would typically involve reference measurements against known standards.

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Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm.

Fully Automatic Electronic Blood Pressure Monitor (KD-743V, KD-743B, KD-752) is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.

This document is a 510(k) summary for a blood pressure monitor, not an AI/ML device. Therefore, the detailed information typically required for describing an AI/ML model's acceptance criteria and validation study (such as training/test set sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) is not provided in this document.

The document discusses the substantial equivalence of the "Fully Automatic Electronic Blood Pressure Monitor" (models KD-743V, KD-743B, KD-752) to predicate devices (KD-753, K183535 and KD-721, K163276). The "acceptance criteria" here refer to meeting established performance standards for non-invasive blood pressure monitors, rather than the performance metrics of an AI algorithm.

Here's a breakdown of what can be extracted and what information is not available from the provided text, in the context of your specific questions:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood pressure monitors are generally based on international standards like ISO 81060-2, which specifies requirements for the accuracy of automated non-invasive sphygmomanometers. The document states:

"Accuracy of the blood pressure monitors for the clinical test report was verified by meeting criteria 1 and criteria 2 of ISO 81060-2."

While the specific numeric criteria (e.g., mean difference and standard deviation of differences between device and reference measurements) are not explicitly listed in a table within this document, meeting ISO 81060-2 criteria 1 and 2 is the acceptance benchmark.

Detailed Information as Requested for AI/ML Studies:

1. A table of acceptance criteria and the reported device performance: See table above. This is based on NIBP standards, not AI performance metrics.

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

   • The document refers to "clinical test report of KD-7961" and "clinical test report of KD-972" being used as reference for the subject devices. These reports verified accuracy by meeting ISO 81060-2 criteria.
   • ISO 81060-2 typically recommends a minimum of 85 subjects for validation. While not explicitly stated here for the specific test, it's implied that the reference clinical tests adhered to this.
   • Data Provenance: Not specified (e.g., country of origin). The document states the company is based in Tianjin, China.
   • Retrospective or Prospective: Not specified. Clinical validation studies for medical devices are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of this device study. Ground truth for blood pressure monitors is established by simultaneously measuring blood pressure using a calibrated reference method (e.g., auscultation by trained observers) and the device under test. It's not a consensus-based reading like for imaging. ISO 81060-2 requires a minimum of three trained observers for reference measurements. Their specific qualifications (e.g., years of experience) are not detailed in this summary, beyond "trained observers."

4. Adjudication method for the test set: Not applicable in the AI/ML sense. For NIBP validation, the "adjudication" is the comparison of device readings against the mean of the reference observers' readings, as per ISO 81060-2. There's no consensus or 2+1/3+1 adjudication of images.

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: Not applicable. This is a blood pressure monitor, not an AI-assisted diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the AI/ML sense. The device itself is "standalone" in that it performs the measurement. The "algorithm" here refers to the oscillometric method of blood pressure determination, not a separate AI algorithm that provides diagnostic interpretations.

7. The type of ground truth used: Reference blood pressure measurements obtained by trained observers using a reference method (e.g., auscultation), according to ISO 81060-2.

8. The sample size for the training set: Not applicable. This is a conventional medical device, not an AI/ML device that requires a distinct "training set" for model development. The "algorithm" for blood pressure measurement is based on established oscillometric principles and does not "learn" from a training set in the way an AI model does.

9. How the ground truth for the training set was established: Not applicable, as there's no training set for this type of device.

In summary: The provided document is a regulatory submission for a conventional medical device (blood pressure monitor), not an AI/ML product. Therefore, many of the detailed questions regarding AI/ML model validation are not addressed, as they are not relevant to this type of device. The "acceptance criteria" revolve around established performance standards for blood pressure measurement accuracy (ISO 81060-2).

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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5.3 inches (13.5cm to 21.5cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

The Wrist Blood Pressure Monitor Model BP4350 ("BP4350") is a battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system intended for over-the-counter (OTC) home use. BP4350 is designed for wrist circumference ranging from 5.3 inches to 8.5 inches (13.5cm to 21.5cm). The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an integral controllable Piezoelectric pump and deflates via an electric automatic rapid deflation valve. During inflation, the cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 40 to 180 beats/min.

The device also detects the appearance of irregular heartbeats during the blood pressure measurement process, which is defined as the appearance of two (2) or more heartbeat intervals which differ by greater than 25% from the average heartbeat rhythm. Detection of such irregular rhythms would result in an "irregular heartbeat symbol" displayed along with the blood pressure and pulse rate readings. In addition, a "HIGH" indication appears if the blood pressure recorded is greater than 130/80 based on the AHA/ACC High Blood Pressure Clinical Practice Guideline criterion for Stage 1 Hypertension, published in 2017.

In addition, the device includes an Advanced Positioning Sensor (APS) feature known as the Heart Zone Indicator, which aids the user in determining if the Wrist Cuff is at the correct height in relation to the heart. It makes this determination based on the reading of an accelerometer (integral to the device) to measure the angle of the arm in relation to the table. The APS feature is similar to the predicate device.

The device displays the latest blood pressure reading, while up to 100 readings can be stored in memory. The operation of the device is intended for home use. Functions and other features that are controlled by the end user include applying the wrist cuff to the wrist, powering on/off the system, starting or stopping the blood pressure and pulse measurement cycle, and installing and changing the batteries as needed. As an optional feature, the user can also pair the BP4350 to a smartphone when employing the "Omron connect" app. This app is an optional feature and is only intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app does not provide any diagnostic or measurement functions and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user. Aside from this optional app for smartphones, BP4350 does not connect with other collateral devices.

The provided text describes the 510(k) summary for the Omron Healthcare, Inc. Wrist Blood Pressure Monitor Model BP4350. This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML-driven device.

Therefore, much of the requested information regarding acceptance criteria for an AI/ML device, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and training set details cannot be extracted from this document as it is not an AI/ML device and the study described is a traditional clinical validation for a blood pressure monitor.

However, I can extract the information relevant to a traditional medical device clinical validation study as presented in the document:

1. A table of acceptance criteria and the reported device performance

The document refers to the acceptance criteria implicitly by stating adherence to the ANSI/AAMI/ISO 81060-2:2013 standard for non-invasive sphygmomanometers. This standard dictates the accuracy requirements for blood pressure monitors.

2. Sample sized used for the test set and the data provenance

• Sample Size: The document does not explicitly state the exact sample size (number of subjects) used for the clinical investigation. ANSI/AAMI/ISO 81060-2:2013 typically requires a minimum of 85 subjects for full validation.
• Data Provenance: Not specified in the provided text (e.g., country of origin). The study was a "clinical investigation" which implies it was prospective.

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

• The ground truth was established by "trained medical staff" using an "auscultation method" with a "calibrated sphygmomanometer."
• The exact number of experts and their specific qualifications (e.g., medical doctors, nurses, with how much experience) are not detailed in this summary. The ANSI/AAMI/ISO 81060-2:2013 standard often requires multiple observers to mitigate bias.

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

• The document does not specify any adjudication method for the clinical investigation results. For blood pressure validation, direct comparison to reference measurements from trained observers is the primary method, and the standard outlines protocols for this.

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 study was not done. This study is for a blood pressure monitor, not an AI/ML-driven diagnostic device that relies on human readers interpreting images with or without AI assistance. The device directly measures blood pressure.

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

• This is a standalone device that provides direct blood pressure readings. Its performance is measured independently against a reference standard (auscultation). So, in a sense, its "standalone" performance is what was evaluated. There is no "human-in-the-loop" interaction in the measurement process itself that would alter the device's reading.

7. The type of ground truth used

• The ground truth was established by expert auscultation (manual blood pressure measurement by trained medical staff) using a calibrated sphygmomanometer. This is the gold standard for clinical validation of automated blood pressure devices.

8. The sample size for the training set

• Not applicable. This device is a traditional blood pressure monitor, not an AI/ML device that requires a "training set" in the machine learning sense. Its design and algorithm are based on established oscillometric principles and engineering, not on learning from a large dataset.

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

• Not applicable. See point 8.

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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5.3 inches to 8.5 inches (13.5 cm to 21.5 cm).

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

The Wrist Blood Pressure Monitor (BPM) Model BP6100 ("BP6100") is an automatic, non-invasive, wrist-worn blood pressure measurement system for over-the-counter (OTC) home use. During measurements, an electric pump within the main unit slowly inflates the wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The systolic and diastolic pressures are determined via the oscillometric cuff method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 40 to 180 beats/min.

The BP6100 is intended for use in the adult patient population, in wrist circumferences ranging between 5.3 - 8.5 inches (13.5 - 21.5 cm). During measurement, the device also detects the appearance of irregular heartbeat rhythms. BP6100 further includes administrative functions for automatic storage of the 60 most recent readings taken by the device. The device also provides an "average" function, which can calculate an average reading based on the latest two (2) or three (3) readings, when taken within a 10-minute span.

The operations of BP6100 are primarily through use of buttons. Functions and other features that are controlled by the end user include applying the wrist cuff to the wrist, powering on/off the system, starting or stopping measurements, and installing and changing batteries as needed. It has no potential connection to external power. There are no additional parts or accessories to the BP6100. The BP6100 does not connect to any other devices.

The provided document is a 510(k) summary for the Omron Healthcare, Inc. Wrist Blood Pressure Monitor Model BP6100. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device (Omron Healthcare, Inc. HEM-6131).

Based on the provided information, here's a description of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the Omron BP6100 are primarily aligned with the standards used for the predicate device, K131742 (HEM-6131), and the ANSI/AAMI/ISO 81060-2:2013 standard.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: The document does not explicitly state the numerical sample size for the clinical investigation. It mentions that the study was conducted "in accordance with guideline per ANSI/AAMI/ISO 81060-2:2013 Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type." This standard typically specifies minimum sample sizes (e.g., 85 subjects for validation in the general population). While the exact number isn't present, compliance with this standard implies a sufficient sample size was used.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state if the study was retrospective or prospective, but clinical investigations for device validation like this are almost universally prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• The ground truth for blood pressure measurement in the clinical investigation was established using an "auscultation method using a calibrated sphygmomanometer by trained medical staff."
• The document does not specify the exact number of experts (medical staff) or their specific qualifications (e.g., years of experience, specific medical degree beyond "trained medical staff"). However, for such studies, it implies that the personnel performing the auscultation measurements are qualified and trained according to standard medical practices for blood pressure measurement.

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

• The document does not describe a specific adjudication method like "2+1" or "3+1." The ground truth was established by "trained medical staff" using the auscultation method. In the context of a clinical investigation for a blood pressure monitor validating against an auscultatory reference, the comparison is typically direct, and an adjudication process beyond the core measurement methodology itself is not usually required or described in a 510(k) summary for this type of device.

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 device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance. The study was a clinical investigation validating the accuracy of the device against a reference method (auscultation), not evaluating human performance.

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

• Yes, a standalone performance evaluation was indeed done. The clinical investigation directly validated the accuracy of the BP6100 device's oscillometric measurements ("algorithm only") against the auscultation method. This represents the device's performance without "human-in-the-loop" assistance in the measurement itself, although a human operates the device. The non-clinical bench testing also evaluated the device's standalone performance.

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

• The primary ground truth for the clinical investigation was expert-performed auscultation using a calibrated sphygmomanometer. This is considered the reference standard for non-invasive blood pressure measurement.

8. The sample size for the training set

• The document describes a clinical investigation and bench testing for device validation. It does not mention a "training set" or "test set" in the context of machine learning (AI/ML models). This is a traditional medical device, not an AI device. Therefore, there is no AI model training set.

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

• As this is not an AI/ML device, there was no "training set" in the AI sense, and therefore no ground truth established for such a set. The studies described are for validation of the device's inherent accuracy and performance.

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