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The Apeel CS Plus Catheter Delivery System is intended to provide vascular access including the coronary sinus and serve as a conduit for the delivery and support of other devices where minimizing blood loss is essential.

The Apeel™ CS Plus Catheter Delivery System includes a Peelable Introducer Sheath, Dilator, Cannulator, Detachable Hemostasis Valve with Side Port with 3-way Stopcock, Guidewire, Syringe, Needle, and 2 Valve Bypass Tools. The introducer kits are provided sterile, and are intended for single-use only.

The provided document, K051096, is a Special 510(k) for a device modification of the Apeel™ CS Plus Catheter Delivery System. This type of submission is for device modifications, not for validating new AI algorithms or diagnostic tools. As such, the document does not contain any information related to acceptance criteria, study performance, sample sizes, ground truth establishment, or expert involvement as would be relevant for an AI/diagnostic device.

The submission focuses on establishing substantial equivalence to a predicate device (Apeel CS Catheter Delivery System) and a reference device (Spyglass Angiographic Catheter) for a modified medical device. The "support of the substantial equivalence" section explicitly states: "St. Jude Medical considers the Apeel CS Plus Catheter Delivery System to be substantially equivalent to the predicate and referenced devices."

Therefore, I cannot provide the requested information for an AI/diagnostic device based on this document. The sections you asked for are not applicable to the content of this 510(k) submission.

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