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The Scepter C Occlusion Balloon Catheter is intended for use in the peripheral and neurovasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.

The Scepter C Occlusion Balloon Catheter is a dual coaxial lumen catheter with a nondetachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over a steerable guidewire. Radiopaque marker bands are located at ends of the balloon and distal tip of the catheter to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheters are packaged sterile for single use only.

The provided text describes a 510(k) premarket notification for a medical device (Scepter C Occlusion Balloon Catheter), not an AI/ML-based device. Therefore, the request for acceptance criteria and study details related to an AI/ML device, as well as specific information like multi-reader multi-case studies, standalone algorithm performance, and ground truth establishment for training and test sets, cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to a predicate device through pre-clinical testing, material comparisons, and shared intended use. It does not contain information about AI/ML algorithm performance metrics, human-in-the-loop studies, or the methodologies used to establish ground truth in the context of an AI system.

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