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The CMOS Video-Rhino-Laryngoscope System is indicated to provide visualization of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic procedures.

The CMOS Video-Rhino-Laryngoscope System includes two main components: (1) the CMOS Video-Rhino-Laryngoscope (11102CM) and (2) the CCU. The CMOS Video-Rhino-Laryngoscope is compatible with two KARL STORZ CCUs: C-HUB and C-MAC.

The document provided is a 510(k) Summary for the KARL STORZ CMOS Video-Rhino-Laryngoscope System (K182186). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving specific clinical performance or to meet acceptance criteria through a clinical study in the way an AI/ML device would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and multi-reader multi-case studies is not applicable in this context.

This document focuses on comparing the new device's technical specifications and non-clinical performance data (electrical safety, EMC, bench testing, biocompatibility, reprocessing validation) against recognized standards and its predicate device to show that it is substantially equivalent and does not raise new questions of safety or effectiveness.

Here's a summary of the provided information, addressing the spirit of your request where possible, but highlighting the absence of specific clinical performance acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

This type of request for an AI/ML device would typically involve metrics like sensitivity, specificity, AUC, F1-score, etc., with predefined thresholds. For this traditional medical device, the "acceptance criteria" are compliance with established medical device standards and demonstrating substantial equivalence to a predicate device.

• Insertion Shaft Diameter: 2.9 mm (vs. 3.7 mm for predicate)
• Field of View: 100° (vs. 85° for predicate)
• Depth of Field: 5-50mm (vs. 8-50mm for predicate)
• On-axis Resolution: 16 Lp/mm at 5mm, 1.8Lp/mm at 50mm (vs. 8.0 Lp/mm at 8mm, 1.4 Lp/mm at 50 mm for predicate)
• Other characteristics (Scope Type, Shaft Length, Deflection, Imager Type, Direction of View, Light Source, Reprocessing Methods) are "Same as the subject device" or "Same as the predicate device" (implied same). |

2. Sample size used for the test set and the data provenance:

• Not Applicable. This document does not describe a clinical study with a "test set" in the context of an AI/ML algorithm evaluation. The assessments are based on engineering bench tests, biocompatibility tests, and reprocessing validations rather than clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. Ground truth, in the AI/ML sense, is not established for this type of device submission.

4. Adjudication method for the test set:

• Not Applicable.

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 device is a visualization tool, not an AI-assisted diagnostic or interpretive system. Clinical studies comparing human reader performance are not described.

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

• Not Applicable. This is a physical endoscope system, not an algorithm.

7. The type of ground truth used:

• Not Applicable. The "truth" in this context is defined by adherence to engineering specifications, safety standards, and performance characteristics as verified through non-clinical testing.

8. The sample size for the training set:

• Not Applicable. This device does not involve a "training set" as it is not an AI/ML system.

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

• Not Applicable.

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The KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic 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 Karl Storz CMOS Video Rhino-Laryngoscope System includes a flexible endoscope and a monitor. The rhino-laryngoscope consists of an integrated light located in the handle. The light is transmitted thought the fiber optic bundles and illuminates the anatomy under visualization. A new Storz specific CMOS imaging sensor located at the distal tip of the endoscope shaft which is inserted into the body cavities. The captured video signal is then transferred to the C-MAC monitor for display purposes. The Karl Storz CMOS Video Rhino-laryngoscope is a Class II device under 21 CFR874.4760, Rhino-Laryngoscope and accessories.

The provided 510(k) summary (K103467) describes a medical device, the Karl Storz CMOS Video Rhino-Laryngoscope System, and its substantial equivalence to a predicate device. However, it does not contain the level of detail requested regarding specific acceptance criteria, a dedicated clinical study proving performance against those criteria, or information related to AI integration.

This submission is for a traditional medical device (an endoscope system), not an AI/ML-powered device. Therefore, many of the questions regarding AI-specific evaluation metrics (e.g., effect size of human readers with AI assistance, standalone algorithm performance, training set details) are not applicable to this 510(k) document.

Here's a breakdown of the information that is available and what is absent from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining specific quantitative acceptance criteria for this device's performance against predefined metrics.

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided. This 510(k) submission describes non-clinical performance data (testing to standards) and reprocessing validation, not a clinical study involving a "test set" of patient data in the typical sense for AI/ML devices. Therefore, there's no mention of a test set sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Provided. As there's no clinical "test set" and ground truth establishment in the context of device performance, this information is not present. The device is for visualization, and its performance is assessed against engineering and cleaning standards.

4. Adjudication method for the test set

• Not Applicable / Not Provided. No clinical test set.

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 is a traditional medical device (endoscope), not an AI-assisted device. Therefore, no MRMC study with AI assistance was performed or described.

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

• Not Applicable. This is a traditional medical device, not an AI algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance evaluation is based on compliance with established engineering and biocompatibility standards (e.g., IEC 60601 series, ISO 10993, ISO 8600) and reprocessing validation protocols (AAMI TIRs, FDA draft guidance). It's not clinical "ground truth" derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not Applicable / Not Provided. This is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning.

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

• Not Applicable / Not Provided. As there is no training set for an AI/ML algorithm, this question is not relevant.

In summary: K103467 is a 510(k) submission for a conventional video rhinolaryngoscope system. The approval is based on demonstrating substantial equivalence to a predicate device and compliance with applicable safety, performance, and reprocessing standards, rather than a clinical study evaluating diagnostic accuracy or AI performance. The detailed questions about AI performance metrics, clinical test sets, ground truth establishment, and training data are not addressed in this type of submission.

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