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The SCIMED ChoICE Plus, ChoICE PT Plus and the 182 cm ChoICE PT Vision Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE Plus, ChoICE PT Plus and the 182 cm ChoICE PT Vision Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

The proximal section of the guide wire consists of a differential magnetic (Hiperco®) core wire encased in a FEP or PTFE coated stainless steel hypotube. The Hiperco® core wire/hypotube assembly is attached to the distal stainless steel core wire assembly by means of a weld and an adhesive bond. There are no other changes being made to the proximal section of the guide wires.

The provided document is a "Summary of Safety and Effectiveness" for a medical device (PTCA Guide Wire) seeking 510(k) clearance. It describes the device, its intended use, and a comparison to existing devices to establish substantial equivalence. The document does not describe acceptance criteria for an AI/ML device, nor does it detail a study proving such a device meets acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them, as the input document does not contain this type of information. It specifically focuses on a physical medical device (catheter guide wire) and its mechanical testing, not an AI/ML system.

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