(20 days)
The Karl Storz Video Rhino-Laryngoscope System is indicated for use by physicians for endoscopic diagnosis within the nasal lumens and airway anatomy. The endoscope is intended to provide visualization via a video monitor.
The KARL STORZ Video Rhino-Laryngoscope System includes flexible endoscopes, CCU and lights source unit. The Rhino-Laryngoscope is designed with distal CCD-chip technology which connects to the Karl Storz Camera Control Processor for treatment of ENT procedures. The Karl Storz Video Rhino-Laryngoscope System is a Class II device under 21CFR876.1500, Endoscope and accessories.
This document is a 510(k) summary for the Karl Storz Video Rhino-Laryngoscope System. It is focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria. As such, the requested information regarding acceptance criteria and a study proving the device meets those criteria is not explicitly available in the provided text.
Based on the information provided:
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A table of acceptance criteria and the reported device performance:
Not provided in the document. The submission focuses on substantial equivalence rather than explicit performance acceptance criteria. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document does not describe a performance study with a test set. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth for a test set is not mentioned as a performance study was not conducted or reported. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication method is described. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an endoscope system, not an AI or diagnostic algorithm, so an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant and was not conducted or reported. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is an endoscopic visualization system, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No ground truth is described as a performance study was not conducted or reported. -
The sample size for the training set:
Not applicable. The device is a hardware system, not a machine learning algorithm, so a training set is not applicable. -
How the ground truth for the training set was established:
Not applicable. A training set and ground truth establishment are not relevant for this device.
Summary of the study that proves the device meets the acceptance criteria (based on the provided text):
The provided document describes a 510(k) Pre-market Notification for the Karl Storz Video Rhino-Laryngoscope System. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific, quantitative performance acceptance criteria through a clinical study.
The core argument for the device meeting regulatory requirements (and implicitly, its intended performance) is stated as: "The Karl Storz Video RhinoLaryngoscope System is substantially equivalent to the predicate device since the basic features and intended uses are the same. The minor differences between the Karl Storz Video Rhino-Laryngoscope System and predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices."
Therefore, the "study" proving the device meets acceptance criteria, in this context, is the comparison to an existing legally marketed predicate device, establishing that despite minor differences, the new device functions similarly and poses no new safety or effectiveness concerns. No specific performance metrics or clinical study results with acceptance criteria are presented.
§ 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.