(55 days)
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.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.