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The Convoy Advanced Delivery Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.

The Convoy Advanced Delivery Sheath Kit consists of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart. The Introducer Sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The Introducer Sheath configurations covered under the subject 510(k) Premarket Notification include 8.5 F and 9.5 F diameter, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75″, lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.

The provided text is a 510(k) summary for the Convoy™ Advanced Delivery Sheath Kit, an intracardiac introducer sheath. The purpose of this document is to demonstrate "substantial equivalence" to a predicate device already on the market, meaning the device is safe and effective for its intended use and performs similarly to the predicate.

Crucially, the provided document does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, or ground truth establishment. The 510(k) summary focuses on comparing the new device to a predicate device (Daig Corporation, Fast-Cath Introducing Sheath) in terms of intended use, device description, single-use aspects, sterilization methods, manufacturer, and classification.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or describe a study proving the device meets acceptance criteria, as this information is not present in the given text. The document is solely a regulatory submission for substantial equivalence based on comparison to an existing device, rather than a report on specific performance testing with predefined acceptance criteria.

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