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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 510(k) summary (K962474) describes a medical device, the Olympus FG Grasping Forceps, intended for grasping and retrieving tissue and foreign bodies during endoscopic procedures. It is a premarket notification for a new version of an existing device and does not contain any information about acceptance criteria, device performance studies, or AI/software validation.

Therefore, I cannot provide the requested information in the format given. The document focuses on establishing substantial equivalence to previously cleared devices rather than providing performance evaluation data typically found for diagnostic AI devices.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria or Performance Data: The 510(k) summary does not mention any specific performance metrics (e.g., sensitivity, specificity, accuracy, F1 score) or acceptance criteria for those metrics. It only describes the intended use and physical characteristics of the device.
• No AI/Software Component: The device is a physical grasping forceps, not an AI or software-driven diagnostic or therapeutic tool. Therefore, concepts like "test set," "training set," "ground truth," "MRMC study," "stand-alone performance," or "human reader improvement with AI" are not applicable.
• No Study Described: The document is a regulatory submission summary, not a study report. It states that the device is "substantially equivalent" to predicate devices, implying that its performance is expected to be similar, but it does not present new study data to prove this equivalence in terms of specific performance metrics.

In summary, the provided document is not relevant to the questions posed, as it describes a mechanical medical device and lacks any data or discussion regarding performance acceptance criteria or a study demonstrating such performance, especially concerning AI or software validation.

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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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