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To be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile, cystic, pancreatic, and right and left hepatic ducts.

The FXWire™ Advanced Measurement Guidewire is a kink resistant metal alloy cored guidewire, which is encapsulated in a PTFE jacket. The guidewire has a flexible radiopaque tip, with a hydrophilic coating for enhanced lubricity. At the distal end of the guidewire, there are painted marker bands beginning at 6cm and extending to 30cm from the distal tip of the guidewire, as well as two radiopaque marker bands placed at 10cm and 15 cm from the distal tip of the guidewire. Additionally, at the proximal end of the guidewire, endoscopic marker bands have been placed beginning at 210cm and extending to 270cm from the distal tip of the guidewire. These marker bands enable endoscopic and fluoroscopic visualization of movement, as well as estimation of stricture length. This guidewire meets the recognized standard for high frequency current leakage (Reference ANSI/AAMI Standard HF 18-1993) when used with a sphinctertome and may be left in place during electrosurgical cutting.

The provided text is a 510(k) summary for the FXWire™ Advanced Measurement Guidewire. It describes the device, its intended use, and its technological characteristics. However, it does not contain specific acceptance criteria, a detailed study design, or reported device performance metrics in a way that allows for the completion of the requested table and information points.

The summary states: "Design verification data demonstrated that the FXWire™ Advanced Measurement [Guidewire] met the performance requirements and is as safe and effective as the predicate device." But it does not provide the "performance requirements" (acceptance criteria) themselves, nor does it quantify the "performance."

Therefore, I cannot fulfill your request for the acceptance criteria table and the detailed study information as the necessary data is not present in the provided document.

Missing Information:

• Specific Acceptance Criteria: The document mentions "performance requirements" but does not list them (e.g., specific thresholds for tensile strength, lubrication, marker band accuracy, etc.).
• Reported Device Performance: No quantitative results from any tests are presented.
• Study Design Details: No information regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment is included for any performance testing.

Without the actual "design verification data" or at least a summary of its results against defined criteria, I am unable to create the requested table and provide the detailed study information.

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