(282 days)
The Schoelly CMOS Video Nasopharyngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhinoflaryngoscopic technique. The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor.
The Schoelly CMOS Video Nasopharyngoscope System consists of a flexible and steerable endoscope and a camera control unit (CCU) for regulation of light intensity and connection to a monitor, PC, medical video recorder or printer for image display or image documentation.
The endoscope has outer surfaces mainly made from plastic. The endoscope handle incorporates a control lever to bend the distal tip and an integrated LED light source. Light is transmitted through fiberoptic bundles illuminating the anatomy under investigation. The video signal is captured by a CMOS imaging sensor located at the tip of the endoscope shaft and transferred to the CCU.
The endoscope further incorporates a ventilation system to protect the shaft. The exhaust valve at the endoscope handle can further be used for leakage testing. For this purpose the system is accompanied by a leakage tester and accessories.
The Schoelly CMOS Video Nasopharyngoscope System is delivered in a non-sterile condition and is already CE marked.
The provided document K132009 for the Schoelly CMOS Video Nasopharyngoscope System is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria based on studies involving clinical outcomes or diagnostic performance metrics like sensitivity, specificity, or AUC.
Therefore, the document does not contain the information requested regarding acceptance criteria related to diagnostic performance or image interpretation, nor does it describe a study assessing such performance (like a standalone study or MRMC study).
The "acceptance criteria" mentioned in the document refer to general safety and performance standards for a medical device of its type, confirmed through non-clinical testing, rather than criteria for diagnostic accuracy or human reader improvement.
Here's a breakdown of why each requested point cannot be addressed from the provided text:
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A table of acceptance criteria and the reported device performance: Not available. The document states, "Performance data demonstrated that the Schoelly CMOS Video Nasopharyngoscope System has met pre-determined acceptance criteria and is substantially equivalent to the predicate devices." However, these acceptance criteria are related to engineering, safety (IEC standards), biocompatibility (ISO 10993), and reprocessing validation, not image interpretation performance or diagnostic accuracy.
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Sample size used for the test set and the data provenance: Not applicable. There is no diagnostic "test set" described as the submission is for a device for visualization, not for an AI/CAD system or a diagnostic tool requiring such a test set. The non-clinical tests involved physical device testing, reprocessing validation, and electrical safety, not the analysis of medical images or patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment experts are mentioned because there's no diagnostic test set being evaluated.
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Adjudication method: Not applicable. No adjudication is mentioned for diagnostic results.
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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 type of study is for evaluating AI-assisted diagnostic tools. The Schoelly CMOS Video Nasopharyngoscope System is a visualization device, not an AI or CAD system.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is not an algorithm that would have standalone performance.
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The type of ground truth used: Not applicable. No diagnostic ground truth is established or used for performance evaluation in this 510(k). The evaluation is around the physical and functional aspects of the endoscope itself.
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The sample size for the training set: Not applicable. There is no AI component, and thus no training set.
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How the ground truth for the training set was established: Not applicable. There is no AI component, and thus no training set or ground truth establishment for it.
In summary, the provided 510(k) document for the Schoelly CMOS Video Nasopharyngoscope System is a regulatory submission for a medical device (endoscope) that emphasizes substantial equivalence to predicate devices based on non-clinical engineering, safety, and reprocessing performance, rather than clinical diagnostic performance metrics and studies involving image interpretation by human experts or AI.
§ 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.