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By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel.

Blood-pressure meter, Model BPW120

The provided document is a 510(k) premarket notification approval letter for a blood pressure meter. It does not contain information about acceptance criteria, study details, or ground truth for an AI/ML device. Therefore, I cannot extract the requested information from this document.

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By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel.

Blood-pressure meter, Model BPW128

This document is a 510(k) clearance letter from the FDA for a blood pressure monitor (Model BPW128) and largely focuses on regulatory approval rather than a detailed study report with acceptance criteria. As such, most of the requested information cannot be extracted from the provided text.

Here is what can be determined from the document:

• Device: Blood-pressure Meter, Model BPW128
• Intended Use: "By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel. The intended for use of this device is for age 15 and above."

The document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size.
• Whether a standalone performance study was done.
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

In summary, this document is an FDA clearance letter confirming substantial equivalence to a predicate device, which implies the device meets certain safety and effectiveness standards, but it does not provide the specific details of performance data and study methodologies that would typically be included in a technical report or scientific publication.

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