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The ULYSS Multi View Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.

The ULYSS Multi View Sinuscope is a 4.3 mm rigid endoscope. The sinuscope is intended for visualization only and does not include operative channels. Instruments do not go through nor come in contact with the scope.
The handle part of the ULYSS Multi View Sinuscope incorporates two rotating dials that permit continuous adjustment of the direction of view from 10° to 100° by means of small magnets incorporated into the sinuscope body; 340° rotation of the outer tube (from -170° to +170°). The sinuscope is provided with a rod lens system to transmit images and bundled optical fibers to transmit light from an external light source to illuminate the visual field. A light guide connector is provided for connection to an Olympus®, Storz® or Wolf® light cable by means of an appropriate adapter. The endoscope is also provided with an eyepiece that is compatible with a standard camera coupler.
The ULYSS Multi View Sinuscope is a reusable device and must be cleaned and sterilized before use.

I'm sorry, but this document does not contain the information requested. This document is a 510(k) premarket notification decision letter and a summary of safety and effectiveness for a medical device called the ULYSS Multi View Sinuscope. It describes the device, its intended use, and compares its technological characteristics to predicate devices.

However, it does not provide details about acceptance criteria for performance metrics or a study that specifically proves the device meets those criteria in the way you've outlined (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies).

The "Performance Data" section (on page 4) mentions "bench testing and a cadaver study" and that "The ULYSS Multi View Sinuscope has met all specified design and performance requirements." but it does not elaborate on the specific acceptance criteria, the methodology of these studies, or the results in a quantifiable manner that would allow me to populate the tables you've requested.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts and their qualifications for establishing ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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