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The Schoelly CMOS Video Nasopharyngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique. The endoscopic diagnosis within the nasal lumens and airway 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 shaust 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.

This document is a 510(k) summary for a Special 510(k) submission, meaning the changes described are limited to a modification of an already cleared device. In this specific case, the only change is an update to the Instructions for Use to add a validated method for high-level disinfection.

Therefore, the "device performance" described is specifically the performance of the High-Level Disinfection (HLD) process, not the overall performance of the nasopharyngoscope system for its intended diagnostic use. The study proves the HLD process meets the acceptance criteria for disinfection efficacy.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for HLD Efficacy Test: "In total, five results for microbial reduction by HLD and three inoculation control results were obtained as part of the efficacy study." This refers to the number of test devices and control devices used in the disinfection validation.
• Data Provenance: The devices used for validation had "previously been in clinical use to ensure 'real life' conditions." This suggests the data provenance is retrospective clinical use, but the validation itself was a prospective laboratory study performed on these used devices. The country of origin for the data is not explicitly stated, but the manufacturer is based in Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to this specific study. The "ground truth" for the HLD efficacy study was established through laboratory methods (culturing viable indicator organisms to determine log reduction), not through expert clinical consensus or interpretation of images.

4. Adjudication Method for the Test Set

This is not applicable. The HLD efficacy test involved quantitative microbiological culturing and functional/material testing, not human interpretation that would require adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study involves human readers evaluating cases with and without AI assistance and is relevant for evaluating diagnostic accuracy, which is not the focus of this specific 510(k) submission (which only concerns HLD validation).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This concept is not applicable. There is no "algorithm" or AI in the context of high-level disinfection validation. The study evaluated the mechanical and chemical process of disinfection.

7. The type of ground truth used

The ground truth used for the HLD efficacy study was laboratory-derived quantitative microbiological counts. Specifically, the number of viable indicator organisms (Mycobacterium terrae) remaining after disinfection, determined by culturing.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of validating a high-level disinfection process. This is a laboratory validation, not a machine learning model.

9. How the ground truth for the training set was established

This is not applicable for the reasons stated above.

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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method: Not applicable. No adjudication is mentioned for diagnostic results.

5. 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.

6. 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.

7. 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.

8. The sample size for the training set: Not applicable. There is no AI component, and thus no training set.

9. 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.

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