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The upper arm blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken.

Digital Automatic Blood Pressure Monitor MD36 Series (Subject Device) are non-invasive blood pressure measurement systems for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel.

The Subject Device utilize the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.

The Subject Device equipped with Bluetooth transmission which enable user to transfer the measurement record from the device to a mobile platform through Bluetooth. User can manage the measurement record by using the mobile application.

Here's an analysis of the acceptance criteria and the study conducted for the Digital Automatic Blood Pressure Monitor MD36 Series, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for blood pressure monitors is accuracy. The document refers to ISO 81060-2 for clinical accuracy testing.

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

• Sample Size: 100 patients for each cuff size (standard: 49 males and 51 females; universal: 44 males and 56 females).
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. Given that the manufacturer is Grandway Technology (Shenzhen) Limited, China, and the study was likely conducted to support a US FDA submission, it's possible the study was conducted in China or a region where clinical studies for international regulatory submissions are common. It is a prospective study, as patients were "invited for the study" and measurements were "repeated alternatively."

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

• Number of Experts: The ground truth was established using the "standard auscultation method." This method typically involves trained medical professionals. While the exact number isn't specified, it would imply at least one, and likely multiple, trained personnel performing the auscultation measurements.
• Qualifications of Experts: The document states "Standard auscultation method was used as the reference blood pressure monitor." This implies trained medical personnel (e.g., nurses, doctors) who are proficient in manual blood pressure measurement using a stethoscope and sphygmomanometer. Specific qualifications like experience level (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set beyond obtaining measurements from the "standard auscultation method" and directly comparing them to the device's readings. The study design mentions measurements were "repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2," suggesting a direct comparison without a separate adjudication panel.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging AI, where human readers interpret cases with and without AI assistance. This device is an automated blood pressure monitor, not an AI interpretation system for human readers.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was conducted. The clinical accuracy testing described in "Clinical Test Summary" is a standalone performance study, assessing the device's accuracy (algorithm only, as it's an automated device) against a reference standard (auscultation) without human-in-the-loop interpretation adjustment.

7. Type of Ground Truth Used

• The type of ground truth used was expert consensus (via standard auscultation method). The auscultation method, performed by a trained professional, serves as the clinical reference standard against which the automated device's measurements are compared.

8. Sample Size for the Training Set

• The document does not explicitly mention a "training set" or its sample size. This is typical for a medical device that relies on established physical principles and calibrated hardware (oscillometric methodology) rather than a machine learning model that requires explicit training data. The development and internal validation of the device would have involved calibration and testing, but not in the same sense as "training data" for an AI algorithm.

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

• As mentioned above, the concept of a "training set ground truth" as it applies to AI/ML is not directly applicable here. The device's underlying principles are based on the oscillometric method. The accuracy claims are validated through the clinical performance study against the auscultation method.

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The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken. You are also warned of possible existing irregular heartbeat.

Digital Automatic Wrist Blood Pressure Monitor MD4300 (Subject Device) are non-invasive blood pressure measurement systems for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel.

The Subject Device utilize the oscillometric methodology, in which an inflatable cuff is wrapped around the wrist of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.

The Subject Device equipped with Bluetooth transmission, which enable user to transfer the measurement record from the device to a mobile platform through Bluetooth. User can manage the measurement record by using the mobile application.

Here's a breakdown of the acceptance criteria and study information for the "Digital Automatic Wrist Blood Pressure Monitor MD4300" based on the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Clinical Test Set: 100 patients (60 males and 40 females).
• Data Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). The "Clinical Test Summary" just states that "One hundred patients...were invited for the study."

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The ground truth was established using the "Standard auscultation method," which implies trained medical professionals (e.g., doctors or nurses) for manual blood pressure measurement.

4. Adjudication Method for the Test Set

• The text describes a comparison method: "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2." This suggests a direct comparison between the device's reading and the auscultation reading for each patient. There is no mention of an adjudication process (e.g., 2+1 or 3+1) if discrepancies arose.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a clinical accuracy study comparing the device against a reference standard (auscultation), not a comparative effectiveness study with human readers assisted by AI.

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

• Yes, the clinical test described is a standalone performance test of the device itself (algorithm and hardware) against the auscultation ground truth. There is no mention of "human-in-the-loop performance" or AI assistance in the context of this device.

7. The Type of Ground Truth Used

• The ground truth used was expert measurement/reference standard, specifically the "Standard auscultation method." This is considered a gold standard for non-invasive blood pressure measurement.

8. The Sample Size for the Training Set

• The document describes a clinical validation study (test set) of 100 patients. It does not mention a "training set" or any machine learning model training process for this device. The device likely relies on established oscillometric principles and calibration, not a data-driven machine learning model that requires a distinct training set.

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

• As no training set is mentioned or implied for a machine learning model, this question is not applicable. The device's operation is based on oscillometric methodology rather than AI training.

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This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.

Digital Automatic Blood Pressure Monitor BPM41 Series and Digital Automatic Blood Pressure Monitor BPM45 Series (Subject Device) are non-invasive blood pressure measurement systems for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The Subject Device utilize the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.

Here's a summary 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 for Test Set and Data Provenance

• Sample Size:
  • BPM41 Series: One hundred patients (50 males and 50 females)
  • BPM45 Series: One hundred patients (51 males and 49 females)
• Data Provenance: Not specified in the provided text. The location of the clinical study (e.g., country of origin) is not mentioned. It is a prospective clinical study, as patients "were invited for the study."

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

• The ground truth was established using the "Standard auscultation method." This method typically involves trained medical professionals (e.g., doctors, nurses) taking manual blood pressure measurements.
• The exact number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not explicitly stated in the document. However, the use of "Standard auscultation method" implies measurement by qualified healthcare personnel.

4. Adjudication Method for the Test Set

• The adjudication method is described as "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2." This suggests a direct comparison method rather than a formal expert consensus/adjudication. Each measurement from the device was compared against the corresponding auscultation measurement taken by the human observer.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The study focused on the device's accuracy against a gold standard (auscultation), not on comparing human reader performance with and without AI assistance.

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

• Yes, the clinical study performed to evaluate the device's accuracy against the standard auscultation method can be considered a standalone performance evaluation. The device (algorithm) provides a measurement, and that measurement is compared to the ground truth. There isn't an explicit "human-in-the-loop" scenario described in the testing for accuracy.

7. The Type of Ground Truth Used

• The type of ground truth used was expert auscultation, which is considered the clinical gold standard for non-invasive blood pressure measurement.

8. The Sample Size for the Training Set

• The document does not specify the sample size for the training set. The clinical study described is for validation of the device's accuracy.

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

• The document does not provide information on how the ground truth for any potential training set was established. The clinical study details are exclusively for the clinical validation of the device.

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The upper arm blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken.

Digital Automatic Blood Pressure Monitor MD3600 (Subject Device) are non-invasive blood pressure measurement systems for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel.

The Subject Device utilize the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.

The Subject Device equipped with Bluetooth transmission, which enable user to transfer the measurement record from the device to a mobile platform through Bluetooth. User can manage the measurement record by using the mobile application.

Acceptance Cryiteria and Study Data for Digital Automatic Blood Pressure Monitor MD3600

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the predicate device's acceptance criteria, which are identical to the subject device's criteria given the statement "All of the clinical and non-clinical testing performed on the Subject Device are same as the Predicate Device. Therefore, no bench test is conducted to show the performance of the Subject Device are equivalent to the Predicate Device." The key performance criteria for a non-invasive blood pressure measurement system are accuracy and range.

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

• Sample Size for Test Set: 100 patients (49 males and 51 females).
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data or if it was retrospective or prospective. However, based on the submission being from "GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED" in "Shenzhen, People's Republic of China," and the clinical study being conducted to support FDA clearance, it is likely a prospective study. The location of the study subjects (e.g., country) is not specified.

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

• The document implies that the ground truth for the test set was established using a "Standard auscultation method" by a medical professional or professionals.
• Number of Experts: Not explicitly stated, but typically, auscultation involves at least one trained observer.
• Qualifications of Experts: Not explicitly stated, but the "Standard auscultation method" implies a trained medical professional (e.g., a physician, nurse, or technician with appropriate training in blood pressure measurement).

4. Adjudication Method for the Test Set

The adjudication method appears to be a direct comparison against the "Standard auscultation method." Measurements were "repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2." This suggests a comparative, side-by-side measurement rather than an adjudication process between multiple expert readings of the device outputs.

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

• No, a MRMC comparative effectiveness study was not done. The study described focuses on the standalone performance of the device against a reference standard (auscultation), not on how human readers' performance improves with or without AI assistance. The device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human-in-the-loop performance measurement.

6. Standalone Performance Study

• Yes, a standalone study was done. The clinical test described focuses on the device's ability to accurately measure blood pressure and pulse rate independently, comparing its readings directly against the "Standard auscultation method." This is a standalone performance evaluation of the algorithm/device.

7. Type of Ground Truth Used

• Expert Consensus (Auscultation): The ground truth used was established by a "Standard auscultation method," which relies on a trained human observer using a stethoscope and sphygmomanometer as the reference standard for blood pressure measurement. This is a form of expert-derived ground truth.

8. Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set. Blood pressure monitors like this typically use algorithms developed and validated over many years, often using large, proprietary datasets, which are not usually detailed in 510(k) summaries unless they are novel AI/ML algorithms. The 510(k) summary focuses on the validation of the final device rather than the underlying algorithm development.

9. How Ground Truth for the Training Set Was Established

• The document does not provide information on how the ground truth for the training set was established. Similar to point 8, this information is typically part of the device's research and development and not always explicitly detailed in a 510(k) summary for a well-established device type like a blood pressure monitor. The assumption would be that the training data, if any specific to the algorithm, would have been established through clinically validated reference methods, likely auscultation, similar to the test set ground truth.

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This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist.

Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the wrist of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.

Here's an analysis of the acceptance criteria and study relevant to the Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series, based on the provided text:

Device: Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series (Models MD2200 and MD2210)

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for accuracy are based on ISO 81060-2. The document mentions blood pressure measurement accuracy of ± 3 mmHg and pulse rate measurement accuracy of ± 5% of the reading.

Note: While the document explicitly states "± 3 mmHg" for BP accuracy and "± 5% of the reading" for pulse rate accuracy under the "Blood Pressure Measurement Accuracy" and "Pulse Rate Measurement Accuracy" rows respectively (Page 6, and in the table of comparison with predicate device at page 5), for blood pressure, the ISO 81060-2 standard (which is cited as the basis for the clinical test) typically uses criteria of mean difference ≤ 5 mmHg with a standard deviation ≤ 8 mmHg when assessing accuracy against a reference measurement.

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

• Sample Size: 100 patients (49 males and 51 females)
• Data Provenance: Not explicitly stated regarding country of origin, but the study was described as a "Clinical Test Summary" to insure clinical accuracy, suggesting a prospective study designed for this device.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated, though it mentions "Standard auscultation method was used as the reference blood pressure monitor," which implies trained medical professionals (e.g., physicians, nurses) performed the auscultation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The document mentions "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in [a likely document reference: 209008 051 which is cut off]." This suggests a direct comparison method rather than an adjudication process between multiple experts for ground truth. The "standard auscultation method" itself serves as the reference.

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

• Not done/Applicable: This type of study (MRMC) is generally not applicable to a device like a blood pressure monitor, which provides a direct measurement rather than an interpretation requiring human readers.

6. Standalone (Algorithm Only) Performance Study

• Yes: The clinical accuracy study, where the device's readings were compared against the standard auscultation method, is a standalone performance study of the algorithm (device) without human-in-the-loop performance improvement.

7. Type of Ground Truth Used

• Expert Consensus / Reference Standard: The ground truth was established using the "standard auscultation method" by a medical professional, which serves as a reference standard for non-invasive blood pressure measurement.

8. Sample Size for the Training Set

• Not Applicable / Not Mentioned: This device uses an oscillometric methodology and is likely based on established physiological principles and algorithms rather than a machine learning model requiring a separate "training set" in the conventional sense of AI/ML. The clinical study mentioned is for validating performance, not for training.

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

• Not Applicable / Not Mentioned: As noted above, the concept of a "training set" and associated ground truth establishment is not typically relevant for this type of device.

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This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure on an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.

Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading. The key components of device are: a pressure sensor, an electric valve and an electronic control module together with an electric pump.

The information provided describes the Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series. Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood pressure measurement devices are typically defined by international standards like ISO 81060-2. The document explicitly references compliance with IEC 81060-2:2009 (and
the new device uses IEC 81060-2:2013). While the document does not list the specific numerical acceptance criteria from this standard, it states that the device was tested in accordance with it and shows the reported performance for key metrics.

Note: The document states compliance with ISO 81060-2. The numerical acceptance criteria for mean difference and standard deviation are standard requirements within ISO 81060-2 for evaluating automated sphygmomanometers. While not explicitly listed with these specifics in the document, the stated "± 3 mmHg" for blood pressure accuracy implies compliance with these underlying statistical criteria.

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

• Sample Size: One hundred patients (49 males and 51 females).
• Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective as patients were "invited for the study" and measurements were taken during the study.

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

• Number of Experts: The document does not explicitly state the number of experts. However, it indicates that "Standard auscultation method was used as the reference blood pressure monitor," which implies measurement by trained human observers (likely medical professionals) using a stethoscope and sphygmomanometer.
• Qualifications of Experts: Not specified. However, for a clinical accuracy study using auscultation as the reference, the operators are typically trained medical personnel (e.g., physicians, nurses, or trained technicians) who are proficient in the auscultatory method.

4. Adjudication Method for the Test Set

• The document implies that the auscultation method serves as the ground truth comparator. It states, "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2." This suggests a direct comparison method rather than an adjudication process between multiple automated device readings or between the device and multiple human observers. There is no mention of 2+1, 3+1, or other adjudication methods.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the accuracy of the device against a gold standard (auscultation), not on how human readers might improve with or without AI assistance, as AI is not a component of this blood pressure monitor. The device is a standalone measurement system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone performance study was done. The clinical test evaluated the Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series as a standalone device, measuring its accuracy against the reference auscultation method without human intervention in the device's measurement process.

7. Type of Ground Truth Used

• The ground truth used was established by the standard auscultation method. This is considered the clinical gold standard for non-invasive blood pressure measurement.

8. Sample Size for the Training Set

• There is no mention of a training set in the provided document. This device is a traditional medical device (blood pressure monitor) that operates based on a pre-programmed algorithm (oscillometric methodology) rather than a machine learning or AI algorithm that requires a "training set."

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

• As there is no mention of a training set, the question is not applicable.

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The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you to quickly and easily measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the wrist, save the measurements and display the development of the measurements.

Digital Automatic Wrist Blood Pressure Monitor MD3200 is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the wrist of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.

The document describes the Digital Automatic Wrist Blood Pressure Monitor MD3200 and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is primarily assessed against accuracy values for blood pressure and pulse rate measurements.

Note: The document explicitly states that the device's accuracy for BP measurement is ± 3 mmHg and for pulse rate measurement is ± 5% of the reading. It also mentions compliance with ISO 81060-2:2013 for clinical accuracy, which is the standard outlining these accuracy requirements.

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

• Sample Size: 100 patients (45 males and 55 females)
• Data Provenance: The document does not explicitly state the country of origin but mentions the study was conducted to insure clinical accuracy in accordance with ISO 81060-2:2013. The nature of the study (patients invited for measurements) indicates it was prospective.

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

• Number of Experts: The document does not specify the number of experts but states that the "Standard auscultation method was used as the reference blood pressure monitor". This implies trained medical professionals (e.g., doctors, nurses, or technicians certified in blood pressure measurement) would have performed the auscultation.
• Qualifications of Experts: Not explicitly stated, but implicitly, they would be qualified to perform the auscultation method accurately.

4. Adjudication Method for the Test Set

• The document states: "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013." This implies a direct comparison method where readings from the device are compared to the reference standard (auscultation) taken at the same time or in alternating sequences. There's no mention of an "adjudication" process in the typical sense of multiple experts independently reviewing and then resolving discrepancies. The auscultation itself serves as the ground truth.

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 study concerns a standalone blood pressure monitoring device. It does not involve human readers interpreting images or data, nor does it involve AI assistance in that context. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• Yes, a standalone performance study was done. The device itself is an "Automatic Wrist Blood Pressure Monitor," implying it operates autonomously to measure and display blood pressure and pulse rate. The clinical test evaluated the accuracy of this device's measurements against a reference standard (auscultation) in a clinical setting, without a human "in the loop" to interpret the device's readings and make a diagnosis. The device generates the readings directly.

7. The Type of Ground Truth Used

• The ground truth used was expert measurement/reference standard, specifically the "Standard auscultation method." Auscultation by a trained professional is considered the gold standard for non-invasive blood pressure measurement.

8. The Sample Size for the Training Set

• The document does not provide information about a separate "training set" or its size. Blood pressure monitors like this typically do not involve machine learning models that require a distinct training set in the same way an AI diagnostic tool would. The device's calibration and algorithm development would have occurred during its engineering phase, likely using internal testing data, but this is not discussed in terms of a "training set" for regulatory submission.

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

• As a training set is not explicitly mentioned or described, the method for establishing its ground truth is not provided in the document.

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Ask a specific question about this device

The upper arm blood pressure monitor is used for non-invasive measurement and monitoring for adult's arterial blood pressure. You can use it to measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the upper arm. Quickly and easily, storing the results and displaying the progression of readings together with the average.

Digital Automatic Blood Pressure Monitor MD2300 is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.

The acceptance criteria for the Digital Automatic Blood Pressure Monitor MD2300, and the study proving its adherence to these criteria, can be summarized as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical values for mean difference and standard deviation from the clinical test report are not provided in the document, but the document states that the testing was done "in accordance with ISO 81060-2:2013." This standard specifies the acceptance criteria for accuracy of non-invasive sphygmomanometers. Therefore, it is inferred that the device met these criteria.

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

• Sample Size for Test Set: 100 patients (49 males and 51 females).
• Data Provenance: The document does not explicitly state the country of origin.
• Retrospective or Prospective: Prospective, as patients were "invited for the 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 or qualifications of experts. However, it mentions that the "Standard auscultation method was used as the reference blood pressure monitor." This method typically involves trained medical professionals. The ISO 81060-2:2013 standard requires that reference measurements be taken by a trained observer.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for disagreements between ground truth measurements. It states that "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013." This standard has specific requirements for the comparison of measurements between the test device and the reference device.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the accuracy of the device against a standard auscultation method, not on human reader performance with or without AI assistance.

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

Yes, the clinical test described focused on the standalone performance of the Digital Automatic Blood Pressure Monitor MD2300 in measuring blood pressure and pulse rate, without a human-in-the-loop component for interpretation or assistance beyond the standard operation of the device.

7. The Type of Ground Truth Used

The ground truth used was expert measurements via the standard auscultation method. This is considered a gold standard for non-invasive blood pressure measurement.

8. The Sample Size for the Training Set

The document does not provide information about a separate training set or its sample size. The study described focuses on the validation of the device's accuracy. As a non-AI driven device (it uses an oscillometric methodology, not machine learning that would require a distinct training phase), the concept of a "training set" as understood in AI/ML contexts does not directly apply here.

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

As no separate training set is explicitly mentioned or relevant for this type of device based on the provided information, how its ground truth was established is not applicable. The device's operation is based on established physical principles of oscillometry, not on learning from a dataset.

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This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.

Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.

Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and the study proving compliance.

Disclaimer: This document is a 510(k) summary for a blood pressure monitor. It focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive clinical trial report. Therefore, some of your requested information, particularly regarding advanced aspects like MRMC studies, may not be explicitly detailed or even applicable to this type of device submission.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the blood pressure monitor are primarily based on the accuracy standards outlined in ISO 81060-2:2013 and the inherent accuracy specifications of the device itself.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a Clinical Test conducted in accordance with ISO 81060-2:2013.

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

• Sample Size for Test Set: One hundred (100) patients (54 males and 46 females).
• Data Provenance: Not explicitly stated (e.g., country of origin). The study seems to be prospective as it involved inviting patients for the study.

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

The ground truth was established using the Standard Auscultation method. The document does not specify the number of expert clinicians (e.g., physicians, nurses) who performed the auscultation measurements. It also does not provide their specific qualifications or years of experience. It simply refers to the "Standard Auscultation method" as the reference.

4. Adjudication Method for the Test Set

The document states: "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013." This suggests a direct comparison method rather than a separate adjudication process. No specific adjudication method like 2+1 or 3+1 for resolving discrepancies is mentioned, likely because the reference standard (auscultation) is considered the definitive ground truth for each measurement.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role in assessing diagnostic accuracy. For a blood pressure monitor, the performance is assessed against a physical reference measurement (auscultation), not typically against multiple human readers interpreting data.

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

Yes, the described clinical test essentially represents a standalone performance evaluation of the algorithm built into the device. The device takes readings automatically and displays them, and these readings are directly compared to the auscultation reference. There is no human intervention in "interpreting" the device's output to make a diagnosis; the device itself provides the measurement.

7. The Type of Ground Truth Used

The type of ground truth used was expert reference standard (Standard Auscultation method). For blood pressure measurement devices, direct auscultation by a trained professional is the established gold standard for determining actual blood pressure values in a clinical setting.

8. The Sample Size for the Training Set

The document does not specify a separate training set sample size. For medical devices like this blood pressure monitor, particularly those using oscillometric methodology, the core internal algorithms are often developed and validated through extensive engineering, mathematical modeling, and internal testing during the design phase, rather than a "training set" in the machine learning sense. The clinical test described is a validation or test set activity.

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

As no separate training set is explicitly mentioned or detailed in the document, information on how its ground truth was established is not provided. If an internal "training" or development process involved ground truth measurements, these details are not part of this 510(k) summary, which focuses on the final validation study against the predicate device and relevant standards.

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