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WiScope® OM Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney.

WiScope® OM Endoscope System is also intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

WiScope® OM Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney, and the pancreaticobiliary system including the hepatic ducts and the common bile duct. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

This system includes a single-use digital ureteroscope/choledochoscope and an image system.

WiScope® Single-Use Digital Flexible Ureteroscope/Choledochoscope is a modified version of the currently marketed WiScope Single-Use Digital Flexible Ureteroscope device that widen its application area from urinary system to bile ducts. Other than that, nothing has changed. The image system stays the same.

The provided FDA 510(k) summary for the "WiScope OM Endoscope System" focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and intended use, rather than on performance against specific acceptance criteria derived from clinical study results of an AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria, study details for proving device performance (such as sample size, expert ground truth establishment, MRMC studies, standalone performance, and training set information) is not present in the provided document.

The document states:

• "No clinical study is included in this submission." (Page 7, Section 10. Clinical Test Conclusion)
• The comparison focuses on "intended use, technological characteristics, and performance characteristics" relative to predicate devices, and claims the device is "as safe and effective as the predicate devices." (Page 4, Section 8. Comparison of Technological Characteristics)
• "Non-Clinical Test Conclusion" (Page 7, Section 9) refers to previous 510(k) submission K181977 and explicitly states: "There is no change on product design, materials and packaging. The no-clinical performance test stays the same as K181977." This implies that the current submission relies on previously established non-clinical performance, not new studies proving performance against acceptance criteria for an AI/ML component.

This 510(k) submission is for an endoscope system (a medical device), not an AI/ML algorithm that identifies or performs automated tasks. Hence, the questions related to AI/ML specific performance metrics (like sensitivity, specificity, clinical outcome improvement via AI, ground truth establishment for AI, etc.) are not applicable to the content provided.

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