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The Asahi SUOH PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi SUOH PTCA Guide Wire is not to be used in the cerebral blood vessel.

The Asahi SUOH PTCA Guide Wire is A steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body. The guide wire is constructed from a stainless steel core wire with a platinum-nickel and stainless steel coil. The core wire and coil are soldered. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to easily bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE.

The provided text does not describe acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is a 510(k) summary for the Asahi SUOH PTCA Guide Wire, focusing on its substantial equivalence to predicate devices based on technical characteristics and performance data.

Specifically:

• There is no table of acceptance criteria and reported device performance.
• There are no details about sample size, data provenance, number of experts, adjudication methods, or specific study types like MRMC or standalone algorithm performance.
• The text mentions "mechanical and functional bench testing" and a "long history of use in medical devices" for biocompatibility, but it does not provide details about the methodology, results, or specific criteria involved in these evaluations.
• There's no information about training set size or how ground truth was established for a training set, as this type of submission (for a medical device like a guide wire) typically relies on engineering tests and comparison to existing, cleared predicate devices rather than AI/machine learning model validation.

The conclusion of the summary states: "The Asahi SUOH PTCA Guide Wire characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use." This indicates that the primary "acceptance criterion" demonstrated is substantial equivalence to legally marketed predicate devices, rather than meeting specific performance thresholds through a detailed clinical or AI-centric study.

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