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Hydrophilic Coated Angiography Guide Wires are indicated for use for percutaneous entry into a vessel using the Seldinger technique. Hydrophilic Coated Angioplasty (PTCA) Guide Wires are steerable guidewires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.

The Bard Hydrophilic Coated Guide Wire is a guide wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. They may be used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.

The provided documentation does not contain specific acceptance criteria, reported device performance data, details of a specific study intended to prove acceptance criteria, or information on AI/algorithm performance.

Instead, it is a 510(k) summary for a medical device (Bard® Hydrophilic Coated Guide Wire) seeking substantial equivalence to predicate devices. The document indicates that safety and performance testing was performed to demonstrate substantial equivalence, but it does not provide the results of these tests or define acceptance criteria.

Therefore, I cannot populate the requested table or answer most of the specific questions.

Here's what can be extracted based on the provided text:

• Overall Goal: To demonstrate substantial equivalence of the Bard® Hydrophilic Coated Guide Wire to predicate devices.
• Performance Data Mentioned: "Safety and performance testing was performed to demonstrate that the Bard Hydrophilic Coated Guide Wire is substantially equivalent to the predicate devices." (Page 2)

Based on the provided text, the specific information requested in your prompt is not available. The document focuses on regulatory submission for substantial equivalence rather than detailing a specific study with defined acceptance criteria and performance metrics in the format you've requested.

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