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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 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.

The provided text describes the regulatory clearance of a medical device, the "Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series," based on its substantial equivalence to a predicate device. While it mentions clinical and non-clinical tests, it does not provide detailed acceptance criteria or the specific results in a format that directly addresses all the requested points for a "study that proves the device meets the acceptance criteria."

However, I can extract the relevant information and present it in the closest possible format based on the given text.

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

The document references ISO 81060-2:2009 for clinical accuracy. This standard defines the accuracy requirements for non-invasive sphygmomanometers. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation of blood pressure measurements) for ISO 81060-2:2009 are not explicitly stated in this document, the study reports that it was conducted in accordance with this standard. The "reported device performance" is implicitly that the device met these standards, as it received clearance.

For completeness, I will include the blood pressure measurement accuracy range for the device itself, as stated in the comparison table, which serves as a self-declared performance specification.

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: 100 patients (46 males and 54 females)
• Data Provenance: Not specified, but generally, clinical studies for medical devices are prospective. The text indicates "were invited for the study," which suggests a prospective clinical trial. The country of origin of the data is not mentioned within the provided text.

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)

• Number of Experts: Not explicitly stated. The "Standard auscultation method was used as the reference blood pressure monitor" implies that a trained healthcare professional performed the auscultation, which serves as the "ground truth" reference. The number of such professionals is not specified, nor are their specific qualifications (e.g., "physician with X years of experience").

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

• Adjudication Method: Not applicable or not specified. In a blood pressure accuracy study using auscultation as the reference, the auscultatory measurement itself is considered the reference. There isn't typically an "adjudication" process in the sense of reconciling multiple expert interpretations; rather, the accuracy of the device is assessed against this direct reference.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study design is typically used for AI/software-as-a-medical-device (SaMD) products where human readers (e.g., radiologists) are assisted by AI. The device in question is a standalone blood pressure monitor, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Yes, the clinical test described details the standalone performance of the device (Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series) against the reference auscultation method. This is not an "algorithm only" study in the context of AI, but rather the performance of the complete automated device. The device itself operates without continuous human input during the measurement cycle.

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

• Type of Ground Truth: The ground truth for blood pressure measurements was established using the standard auscultation method, which is performed by trained medical professionals (human experts) and is considered the gold standard for non-invasive blood pressure measurement in such studies.

8. The sample size for the training set

• Training Set Sample Size: The document does not describe a "training set." The device is cleared as substantially equivalent to a predicate device, and the mentioned clinical study is a validation or verification test, not a training process for an algorithm. If the device contained a machine learning component, a training set would be relevant, but this is not suggested.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for a machine learning algorithm. The device's operation is based on established oscillometric methodology and engineering principles rather than a trained AI model.

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