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The Schoelly Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including thinology, and endoscopic plastic and reconstructive surgery.

The Schoelly Sinuscope is a rigid reusable endoscope for visualization during Otolaryngology-Head and Neck surgery in conjunction with a commercially available and approved light guide, light source, video camera, monitor, and printer. Light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application.

Schoelly Sinuscopes are manufactured in multiple configurations that differ in insertion tube outer diameter and working length and with respect to optical parameters (direction of view, field of view). Several models of the Schoelly Sinuscope have already been cleared for marketing by FDA (K133682) for the visualization during arthroscopic procedures.

Like other currently marketed sinuscopes, Schoelly Sinuscopes have outer surfaces mainly made from metal (Phynox cobalt-nickel-chromium alloy, 304 stainless steel) and further comprise fiber optics for light transmission and rigid rod-lenses for image transmission.

The Schoelly Sinuscope is delivered in a non-sterile condition and is already CE marked.

The Schoelly Sinuscope is a rigid reusable endoscope intended for visualization during Otolaryngology-Head and Neck surgery. The device's performance was evaluated through non-clinical testing, including temperature, optical parameter, biocompatibility, and performance testing, demonstrating its substantial equivalence to the predicate device, SHARPSITE Ac (K965233).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "sample size" for a test set in the traditional sense of a clinical study with patient data. The testing described is primarily non-clinical, involving laboratory-based evaluations of the device's physical and material properties.

• Test Set: Not applicable in the context of patient data. The "test sets" refer to the Schoelly Sinuscope devices themselves that were subjected to the various physical and chemical tests (e.g., specific units for temperature testing, optical testing, biocompatibility testing, reprocessing validation). The exact number of devices used for each specific test is not detailed.
• Data Provenance: The studies are non-clinical, laboratory-based tests of the device. There is no mention of geographical provenance (e.g., country of origin) or retrospective/prospective classification as it relates to human subject data. The testing was conducted by or on behalf of Schoelly Fiberoptic GmbH, located in Denzlingen, Germany.

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

Not applicable. The ground truth for the non-clinical tests (e.g., temperature, optical parameters, biocompatibility, bonding strength, reprocessing effectiveness) is established by adherence to recognized international standards (e.g., IEC, ISO, AAMI) and internal specifications, rather than expert consensus on medical images or clinical outcomes. The "ground truth" is defined by the objective physical or chemical properties of the device and its demonstrated ability to meet the quantitative and qualitative requirements of these standards.

4. Adjudication Method for the Test Set

Not applicable. As the testing is non-clinical and objective (e.g., measurements against a standard), there is no need for adjudication by multiple human observers to establish a ground truth.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically performed to evaluate the diagnostic accuracy or effectiveness of an AI system or diagnostic device when interpreted by multiple human readers, often comparing performance with and without AI assistance. The Schoelly Sinuscope is a physical medical device (an endoscope) for direct visualization, not an AI-powered diagnostic tool, and its evaluation did not involve human reader interpretation of data for diagnostic purposes in an MRMC setting.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The Schoelly Sinuscope is a physical medical device, not an algorithm or AI system. Therefore, a standalone performance study without human-in-the-loop is not relevant.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is derived from:

• International Standards and Regulations: e.g., IEC 60601-2-18, IEC 60601-1 (for temperature), ISO 8600 series (for optical parameters), ISO 10993 (for biocompatibility), AAMI TIRs, ANSI/AAMI STs, and ISO 14937, ISO 17664, ANSI/AAMI/ISO 17665-1 (for reprocessing).
• Internal Specifications: These specifications set the minimum requirements for the device's optical parameters.
• Predicate Device Performance: For performance testing (e.g., bonding strength), the "ground truth" or acceptance criterion was defined by comparison to the established performance of the legally marketed predicate device, SHARPSITE Ac (K965233).

8. Sample Size for the Training Set

Not applicable. Since the Schoelly Sinuscope is a physical medical device and not an AI/machine learning system, there is no "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set as this is not an AI/machine learning device.

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