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The Pathfinder™ Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).

The Pathfinder™ Endoscope Overtube (Pathfinder™) device consists of a flexible overtube that may be connected to vacuum for rigidization via an attached stopcock and is used with an endoscope for procedures in the gastrointestinal tract. The stopcock is connected to the vacuum line which is connected to free space within the device and is completely contained, forming the vacuumable volume. The stopcock has two positions: the first position connects the vacuumable volume within the device to atmosphere (vent) to stay in the flexible condition, and the second position connects the device to a source of vacuum to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to surrounding anatomy. When transitioned to the flexible condition, the device is able to move relative to the patient anatomy and endoscope for navigation through the GI tract. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations.

This document is a 510(k) premarket notification for a medical device called the Pathfinder™ Endoscope Overtube. It does not describe a study involving an AI-based medical device, nor does it include information on acceptance criteria for such a device.

The document focuses on demonstrating substantial equivalence to a predicate device (KMS Medical EndoGuide) primarily through:

• Comparison of technological characteristics: This involves comparing the design, materials, intended use, and other features of the new device to the predicate.
• Non-clinical performance data: This typically includes biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity) and mechanical testing (simulated use, lubricity, insufflation, insertion/removal, steering, navigation, rigidization/de-rigidization, endoscope compatibility).

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria for an AI-based device and the study proving it meets them. The document does not contain any of the following:

• Table of acceptance criteria and reported device performance for an AI device.
• Sample size used for an AI test set or data provenance.
• Number of experts or their qualifications for establishing ground truth for an AI test set.
• Adjudication method for an AI test set.
• MRMC comparative effectiveness study or human reader improvement with AI assistance.
• Standalone algorithm performance.
• Type of ground truth used for an AI algorithm.
• Sample size for an AI training set.
• How ground truth for an AI training set was established.

The provided text is solely for a traditional medical device (an endoscope overtube) and its regulatory clearance process, not for an AI/ML-based diagnostic or therapeutic device.

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