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Intended for use in facilitating delivery of a PTCA balloon catheter or other cardiovascular device into the cardiovascular system.

The Strategy™ Coronary Wire Guide is used to facilitate delivery of a PTCA balloon catheter or other cardiovascular device into the cardiovascular system. The device will be constructed of stainless steel and platinum with hydrophilic coating. The Strategy™ Coronary Wire Guide outside diameter is 0.014-inch and will be available in 180 and 300 cm lengths with straight and J-curve distal tips. It will be supplied sterile, intended for one-time use.

The provided documents do not contain information about acceptance criteria and a study proving a device meets these criteria. The documents are a 510(k) premarket notification for the "Strategy™ Coronary Wire Guide" and the FDA's response letter indicating substantial equivalence to predicate devices.

Specifically, the information requested in points 1-9 (acceptance criteria table, sample sizes, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for the training set) is entirely absent from these documents.

The submission focuses on establishing substantial equivalence based on similar intended use, materials, and technological characteristics to existing predicate devices (Roadrunner™ RLTF Guide Wire and ACS Hi-Torque Cross-It™ Guide Wire with Hydrocoat™ Coating), rather than presenting a performance study with detailed acceptance criteria.

Therefore, I cannot provide the requested information based on the given input.

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