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The Olympus FG-6/7/8/9/42/47-1 grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body, and excised tissue endoscopically.

The Olympus FG-6/7/8/9/42/47-1 grasping forceps are designed for grasping tissue and/or retrieving foreign body, and excised tissue under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws.

This document is a 510(k) summary for the Olympus FG Grasping Forceps, submitted in 1996. It describes a medical device (grasping forceps) and its intended use.

Based on the provided text, there is no information about acceptance criteria or a study proving device performance against such criteria in the context of AI/algorithm performance.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study and effect size.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document describes a traditional medical device, not an AI or algorithm-based system. The approval process for such a device in 1996 would involve demonstrating substantial equivalence to a predicate device, focusing on material safety, design, and functional performance, rather than algorithm accuracy metrics.

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