(170 days)
The Single-use Flexible Rhinolaryngoscope is designed for use with Vathin Display Units, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.
The Single-use Flexible Rhinolaryngoscope can be connected to the compatible Vathin Display Units and other accessories for examination and treatment of nasal cavity and upper respiratory tract. There are eight subject nasopharyngoscope models: RL-S1800, RL-S1801, RL-E1800, RL-E1801, RL-S1E00, RL-S1E01, RL-E1E00, RL-E1E01. The main differences between product models are in the working channel inner diameter (whether channel is present or not), outer diameter, and rotate function.
This document is a 510(k) summary for a medical device (Single-Use Flexible Rhinolaryngoscope) and primarily focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and non-clinical testing. It explicitly states that no re-review of the 510(k) submission was done for the administrative correction. Therefore, the provided text does NOT contain information regarding acceptance criteria or a study proving that the device meets acceptance criteria related to AI or algorithm performance.
The document details the device's technical specifications and compares them to a predicate device, along with non-clinical tests (biocompatibility, electrical safety, EMC, and general performance testing) that are standard for medical devices of this type to ensure safety and effectiveness. It does not describe any studies involving algorithms, AI, or human reader performance.
Therefore, I cannot provide the requested information based on the provided text, as it does not address AI/algorithm performance. The information requested (multi-reader multi-case studies, standalone algorithm performance, ground truth establishment, sample sizes for training/test sets in the context of AI) is not present in this regulatory submission document about a rhinolaryngoscope.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.