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The Atlantis™ SR and Atlantis™ SR PLUS Imaging Catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound is indicated in patients who are candidates for transluminal coronary interventional procedures.

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The provided text is a 510(k) premarket notification letter from the FDA to Boston Scientific Corporation for their Atlantis™ SR and Atlantis™ SR PLUS Imaging Catheters. This letter approves the marketing of the device based on substantial equivalence to a legally marketed predicate device.

Crucially, this document does NOT contain a study or data proving the device meets specific acceptance criteria.

The 510(k) process in 2004 primarily relied on demonstrating substantial equivalence to a predicate device, meaning it's as safe and effective as a device already on the market. It often does not require detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) would.

Therefore, I cannot provide the requested information from the given text because the text does not include a study or its results. It is simply an FDA clearance letter.

To fully answer your prompt, I would need a document detailing the studies conducted, their methodology, and results, which are typically found in the 510(k) submission itself, not the FDA's clearance letter.

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