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The ANGIODYNAMICS Accu-Vu Sizing Catheter is for use where angiographic diagnosis is indicated.

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The provided text is a 510(k) premarket notification letter from the FDA to AngioDynamics, Inc. It confirms that the AngioDynamics Accu-Vu Sizing Angiographic Catheter is substantially equivalent to legally marketed predicate devices.

*However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details typically found in a study report proving a device meets acceptance criteria.

The 510(k) letter is a regulatory approval document based on a submitted application, not the study report itself. To answer your request, I would need access to the actual 510(k) submission (Design History File Number 506), specifically the sections detailing the studies performed to demonstrate substantial equivalence.

Therefore, I cannot fill in the table or provide the requested information based solely on the text you provided.

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