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The Olympus HX -20-1 Endoscopic Ligator has been designed to be used with Olympus endoscopes in delivering a MAJ-254 Standard Ligation Loop or MAJ-340 Small Ligation Loop designed to prevent or control bleeding following polypectompy of pedunculated polyps.

The Olympus HX-20-1 Endoscopic Ligator is intended to deliver a MAJ-254 Standard Ligation Loop or MAJ-340 Small Ligation Loop to prevent or control bleeding following polypectomy of pedunculated polyps. The Olympus "EndoLoop"is substantially equivalent in intended use to endoscopic ligators marketed by Bard, Microvasive, and Wilson-Cook. The subject ligating device differs from these devices in that it operates via through-the-scope techniques.

This is a 510(k) premarket notification for a medical device (Olympus HX-20-1 Endoscopic Ligator), not a submission for an AI/ML-driven device. Therefore, the information requested about acceptance criteria, study details, and AI/ML specific metrics (like algorithm performance, training/test sets, human-in-the-loop, etc.) is not applicable to this document.

The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use and device description, as required for traditional 510(k) submissions. There's no mention of any AI or software-based components in the device or its evaluation.

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