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The HI-TORQUE IRON MAN™ Guide Wire is a steerable guide wire intended to facilitate placement of balloon dilatation catheters during Percutaneous Transluminal Coronary Angioplasty (PTCA) and Percutaneous Transluminal Angioplasty (PTA). The wire is also intended to facilitate the placement of equipment, such as atherectomy and compatible stent devices, during other diagnostic and therapeutic intravascular procedures. It is not intended for use in the cerebral vasculature.

The proximal and distal portions of the guide wire are constructed from a core assembly. A series of tapers and flats, which reduce the diameter of the core wire distally, vields the desired tip flexibility. The distal 12 to 15 centimeters proximal to the tip of the ACS HI-TOROUE IRON MAN™ Guide Wire are coated with Microglide® while the remaining portion is coated with polytetrafluoroethylene (PTFE). Both coatings are intended to reduce friction for improved movement of the wire within the catheter. The platinum alloy coils provide the physicians with a radiopaque tip.

The provided document describes a medical device, the ACS HI-TORQUE IRON MAN™ Guide Wire, and its substantial equivalence to predicate devices, rather than a study evaluating its performance against specific acceptance criteria in the context of an AI-powered device. Therefore, a direct response to your prompt with specific acceptance criteria, reported device performance in those terms, and details about training/test sets, ground truth, and human expert involvement is not applicable based on the given text.

The document discusses the following:

• Substantial Equivalence: The primary assertion is that the ACS HI-TORQUE IRON MAN™ Guide Wire is substantially equivalent to existing predicate devices (ACS Hi-Torque Extra S'Port™ Guide Wire and Boston Scientific Corporation .014" Platinum Plus™ Guide Wire) in terms of intended use, materials, and design.
• Testing Data:
  • Biocompatibility: Relies on data from the predicate device as the materials are identical.
  • In vivo Testing: Two animal studies compared the new guide wire's performance to predicate wires when used with specific catheters and stent delivery systems. The conclusion was that it performed "as well as or better than" the predicate wires in most parameters.
  • Bench Testing: Evaluated:
    • Tensile strength of the distal tip (pull test) – "adequate"
    • Torsional strength of the distal tip (turns-to-failure test) – "adequate"
    • Rotational accuracy (correlation between proximal and distal rotation) – "adequate torque response"
    • Tip flexibility – "equivalent to that of the predicate and is acceptable"

Therefore, I cannot populate the table or answer the specific questions about AI/algorithm performance. The document describes a traditional medical device submission focused on demonstrating equivalence through mechanical and animal testing, not an AI/ML device with established acceptance criteria based on diagnostic performance metrics like sensitivity, specificity, accuracy, or human reader improvement.

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