(43 days)
The Olympus FG-45/46-1 Grasping Forceps is intended to be used to retrieve foreign bodies and excised tissue specimens endoscopically.
The Olympus FG-45/46-1 Grasping Forceps is specifically designed for foreign body and tissue specimen collection under endoscopic visualization. The FG-45/46-1 consists of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping prong mechanism.
This document describes the Olympus FG-45/46-1 Grasping Forceps, a medical device. Based on the provided 510(k) summary, this device is a physical instrument and not an AI/ML-driven device.
Therefore, the requested information about acceptance criteria, study design, ground truth, expert opinions, and training sets, which are typically associated with the evaluation of AI/ML software devices, is not applicable to this submission.
The 510(k) summary for the Olympus FG-45/46-1 Grasping Forceps focuses on its intended use, device description, and comparison to a predicate device (Olympus FG-2 Reusable Grasping Forceps) to demonstrate substantial equivalence, which is the standard regulatory pathway for this type of device. Performance testing for such devices would typically involve mechanical bench testing (e.g., grasp force, durability, biocompatibility, sterilization validation) rather than the clinical performance metrics outlined in your request.
§ 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.