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• 1. The device is designed to provide signals from which systolic, diastolic pressures and H-Value (arterial stiffness index) can be derived through the use of the Oscillometric method. The device also measure pulse rate.
• 2. Adult Use Only
• 3. For use in the clinical setting or home use under the direction of a physician.

The device is designed to provide signals from which systolic, diastolic pressures and H-Value (arterial stiffness index) can be derived through the use of the Oscillometric method. The device also measure pulse rate.

The provided text is a 510(k) clearance letter from the FDA for the "Vital Vision Arterial Stiffness and Blood Pressure Monitor." It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain any information about the acceptance criteria, device performance, sample sizes, ground truth establishment, or study details.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study report.

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