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BP Pro is intended to be used by adults at home to monitor Blood Pressure (systolic and diastolic) and pulse rate from the upper arm with arm circumference ranging from 9.4 inches to 16.5 inches (24 cm to 42 cm).

The BP Pro Blood Pressure Monitor is a fully automatic table model device that measures blood pressure by means of an inflatable cuff on the upper arm. It employs the Oscillometric Principle.

The provided text is a 510(k) summary for the BP Pro Blood Pressure Monitor. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on identical technological characteristics.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The text explicitly states: "The BP Pro Blood Pressure Monitor is identical to the predicate I.E.M. device except for its name, hence it should raise no new questions of safety and effectiveness. This submitter concludes that the BP Pro Blood Pressure Monitor is therefore substantially equivalent to the predicate device." This indicates that the approval is based on equivalence, not a new performance study.

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