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These instruments (sphincterotomes and guidewires) have been designed to be used with an Olympus endoscope for papillotomy using high-frequency current. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

The subject sphincterotome consists of sphincterotome and preloaded guidewire. It is used in combination with endoscope and electrosurgical unit for papillotomy. The subject sphincterotome is composed of handle section and insertion tube. The preloaded guidewire is used for insertion and exchange of endotherapy accessories including the subject sphincterotome.

The provided text is a 510(k) summary for a medical device (Single Use Preloaded Sphincterotome V) seeking substantial equivalence to predicate devices. It describes the device, its intended use, technological characteristics, and non-clinical testing performed.

However, the document does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in a way that aligns with the requested format (e.g., sensitivity, specificity, accuracy, or similar quantitative performance outcomes compared against expert-established ground truth).

The "Summary of Non-clinical Testing" section states that:

• "Performance testing was conducted to demonstrate the initial performance of the subject device and confirmed that the subject device works as intended."
• "Basic safety and performance testing was performed in accordance with !EC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-2 and IEC 60601-2-18. In addition, verification was conducted to evaluate the mechanical and functional performance."
• "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment."

This language indicates that internal testing was done against established acceptance criteria, but it does not provide the specifics of those criteria or the results in a quantifiable, comparative manner (e.g., a table of acceptance criteria vs. device performance with specific metrics).

The document is primarily focused on demonstrating substantial equivalence based on technological characteristics and compliance with recognized safety and performance standards for an electrosurgical accessory, rather than reporting on a clinical or AI-driven performance study with detailed metrics against a ground truth.

Therefore, it is not possible to fill out the requested table and provide the specific details about a study proving the device meets acceptance criteria as typically found in submissions for AI/ML-driven devices. The provided text describes compliance with general safety and performance standards and risk analysis-driven design verification, not a study evaluating diagnostic performance against a ground truth.

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This instrument has been designed to be used with an Olympus endoscope I mis instrument mas count in the biliary and pancreatic ducts, although it is not designed for the deep insertion into the pancreatic duct.

The subject device is a cannula which has a bending function (angle wire), to be used in accordance with Intended Use of the Device. This bending function enables the subject device to be manipulated in 2 directions and leads to easier insertion into the biliary and pancreatic ducts.

This document is a 510(k) premarket notification for a medical device called the "DISPOSABLE BENDING CANNULA PR-233Q." It focuses on demonstrating substantial equivalence to predicate devices, and therefore, it does not contain acceptance criteria, a study proving device meets acceptance criteria, or information regarding AI performance metrics.

The document describes the device, its intended use, and provides a comparison to predicate devices, focusing on the lack of significant changes that would affect safety or effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or AI performance. The document's purpose is to obtain FDA clearance based on substantial equivalence, not to present a detailed performance study with specific metrics.

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