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To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) and compatible stent devices.

The HI-TORQUE PILOT™ Guide Wire with Hydrocoat Hydrophilic Coating is a guide wire with a maximum diameter of 0.0140" and is available in 175 cm and 190cm extendable lengths and a 300 cm exchange length. There are three HI-TORQUE PILOT™ Guide Wire designs with varying tip stiffness (i.e., HI-TORQUE PILOT™ 50, HI-TORQUE PILOT™ 150, and HI-TORQUE PILOT™ 200 Guide Wires). The distal tip of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J". The straight shape allows the physician to shape the tip according to his/her preference; the J shapes provide the physician the convenience of a J shape without manual shaping. Brachial and femoral markers are located on the proximal segment of the 190 cm and 300 cm guide wires to indicate when the tip of the guide wire is about to exit the guide catheter. The proximal section of the wire is coated with polytetrafluroethylene (PTFE). The distal, polyurethane-covered area, of the wire is coated with hydrocoat hydrophilic coating.

The provided text is a 510(k) summary for guide wires and does not contain information about acceptance criteria or a study proving that a device meets those criteria. It states that "The results of the verification testing demonstrate that the HI-TORQUE PILOT™ Guide Wires meet the established acceptance criteria and performs in a manner equivalent to the predicate device. No new safety or effectiveness issues were raised during the testing program." However, it does not elaborate on what those acceptance criteria are, what specific performance metrics were measured, or details about the study design, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based on the input text. The information is not present in the document.

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