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The Vaso Press system is an external pneumatic compression system intended to lower the risk of deep vein thrombosis (DVT) in patients whom may be at risk

Vaso Press DVT System, Pump Model VP 500 and Sleeve Model VP 501

I am sorry, but the provided text does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device. The document is a 510(k) summary and approval letter, which primarily focuses on the regulatory aspects of device clearance rather than the detailed performance testing and validation studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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Treatment of lymphatic and venous disorders.

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This document is a 510(k) clearance letter from the FDA for the Vaso Press System. It confirms that the device is substantially equivalent to a legally marketed predicate device for the treatment of lymphatic and venous disorders. The letter itself does not contain any information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or study designs (such as MRMC or standalone studies).

Therefore, I cannot provide the requested information based on the text provided. This document is a regulatory approval, not a technical report detailing the performance studies.

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