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The In-Time™ Retrieval Device is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and / or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.

The In-Time™ Retrieval Device consists of a braided catheter shaft, with a radiopaque basket attached to the distal tip of the catheter. The inner lumen of the catheter contains a flexible, guiding corewire, which is tapered from the proximal to distal end. The corewire extends distally 3 cm from the basket and is not removable from the catheter. The corewire can be rotated freely as well as moved distally and proximally within the catheter approximately 1.5 cm. The 3 cm radiopaque distal coil extending from the basket facilitates fluoroscopic visualization. A luer fitting is located on the catheter hub and is used for the attachment of accessories and to facilitate the continuous flush of solution. The catheter shaft is coated with HYDROLENE™, a hydrophilic coating that reduces friction during manipulation in a guide catheter and in blood vessels. The In-Time™ Retrieval Device is designed to be used with a guide catheter. The In-Time™ Retrieval Device can be used in vessel diameters ranging from 2 mm to 4 mm.

The provided text describes the In-Time™ Retrieval Device, a medical device designed for retrieving foreign objects from the vasculature. The document details its technological characteristics and compares them to a predicate device, as well as providing a summary of its verification tests.

However, it does not contain information related to software or AI-powered devices. Therefore, the requested information regarding acceptance criteria and studies (such as sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment) for an AI device is not present in the provided text.

The document focuses on the mechanical and material performance of a physical medical device. The "acceptance criteria" mentioned refer to engineering and biocompatibility standards for the device itself, not for the performance of an algorithm.

Therefore, I cannot fulfill the request as it pertains to an AI/software device, as the provided input describes a non-AI medical device.

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