Search Results

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.

Ask a specific question about this device

Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.

The Arm Blood Pressure Monitor (model: 111, B1681, B1683) are battery-powered or DC powered, automatic, non-invasive blood pressure system and intended to be use in hospital environment or at home. The Arm Blood Pressure Monitor (model: 111, B1682, B1683) are intended for use in adult patient population with arm circumference ranging from 22 cm to 32 cm. These devices are powered by 4 x AA batteries or an AC adaptor (output:5V DC). The device arm cuff inflates using an integral pump and deflates via an electric valve. During deflation, the arm cuff pressure is monitored and pulse waveform data is 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 280 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 2x99 readings can be stored in memory.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criteria for the Arm Blood Pressure Monitor are related to its clinical accuracy, as measured against a reference standard. The standard used is ISO 81060-2:2018.

Table of Acceptance Criteria and Reported Device Performance:

Additional Acceptance Criteria (from ISO 81060-2:2018, Criterion 2):

Study Details Proving Acceptance Criteria

The study conducted was a clinical accuracy study conforming to ISO 81060-2:2018.

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

  • Sample Size: A total of 86 subjects participated in the study.
  • Data Provenance: The study was conducted at Wanxiang Xintian Community Health Serve Center, Xixiang Street, Bao'an District, Shenzhen City, China by Shenzhen Cihai Hospital. The subjects' race was reported as Asian, and ethnicity as "Not Hispanic or Latino." The study is prospective as it describes the procedure for data collection during the study.

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

  • The document implies the use of multiple observers (referred to as "observers" in the procedure steps b, g, and k) to determine blood pressure using the reference sphygmomanometer.
  • Their specific qualifications are not explicitly stated beyond being "observers" using a mercury sphygmomanometer, which implies training in its use for accurate blood pressure measurement.

• 3. Adjudication method for the test set:

  • The document does not explicitly describe an adjudication method for reconciling differences between observers if multiple readings were taken for the ground truth. The procedure indicates that observers "determine the subject's blood pressure," suggesting a single ground truth per measurement instance.

• 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:

  • No, an MRMC comparative effectiveness study was not done. This study is for a standalone automated blood pressure monitor and does not involve human readers' interpretation or AI assistance in that context.

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

  • Yes, a standalone study was done. The device itself is an "Arm Blood Pressure Monitor" and determines blood pressure using its internal software (oscillometric method), without human interpretation required for the blood pressure values. The study directly compares the device's output to a reference standard (mercury sphygmomanometer).

• 6. The type of ground truth used:

  • The ground truth used was expert measurements via a reference sphygmomanometer (mercury sphygmomanometer). This is a recognized standard for blood pressure measurement.

• 7. The sample size for the training set:

  • The document does not specify a separate training set size. The reported study is a clinical validation study for the device's accuracy against a gold standard, in accordance with ISO 81060-2:2018. For a medical device like a blood pressure monitor, the "training" (algorithm development) would typically occur prior to this clinical validation, and the data for that is not usually disclosed in this type of submission. The 86 subjects represent the test set for clinical accuracy.

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

  • As no specific training set is outlined in this document, the method for establishing its ground truth is not provided. However, it can be inferred that developers would use similar reference methods (like mercury sphygmomanometry) during the development and calibration phases of the device.

Ask a specific question about this device

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.

Ask a specific question about this device