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The Statarius™ is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 5-12mm during diagnostic and therapeutic surgical procedures.

The Statarius™ is a manually operated, mechanical surgical device. It is primarily composed of stainless steel and anodized aluminum. The instrument provides for the one handed control for the positioning/repositioning of an endoscope during surgical procedures. The Statarius™ eliminates the need for the surgeon or assistant to continuously hold an endoscope during surgical procedures.

The provided document is a 510(k) summary for the Statarius™ Endoscope Holder, which is a manually operated, mechanical surgical device. It is primarily composed of stainless steel and anodized aluminum and is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 5-12mm during diagnostic and therapeutic surgical procedures.

The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Armand Endoscope Holder, K5050051).

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
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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