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The Reusable Endoscopic Accessory Handle can be used with various types of endoscopic accessories including biopsy forceps and polypectomy snares.

The Reusable Endoscopic Accessory Handle can be used with various types of endoscopic accessories including biopsy forceps and polypectomy snares.

This document describes a reusable endoscopic accessory handle, not an AI/ML powered medical device. Therefore, a table of acceptance criteria and device performance based on AI/ML metrics, as well as details regarding training and test sets, expert ground truth, and comparative effectiveness studies, cannot be extracted or inferred from the provided text.

The document focuses on the safety and effectiveness of a reusable handle for endoscopic accessories. It mentions:

• Product Overview: Its use with various endoscopic accessories (biopsy forceps, polypectomy snares).
• Contraindications: Only general contraindications related to endoscopic procedures themselves.
• Manufacturing Overview: Design, manufacturing, and testing to performance specifications based on predicate devices, good manufacturing practices, and quality assurance methods (MIL-STD-9858).
• Bibliography: References related to gastroenterologic procedures and endoscopy.

There is no mention of an algorithm, AI, machine learning, or any form of automated analysis or interpretation. The performance of this device would be assessed through mechanical, biocompatibility, and sterilization validation testing, not through AI/ML specific metrics.

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