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The Endoscopic Fiberoptic Cable is used to conduct visible light from a light source to an endoscope during a surgical procedure.

Endoscopic Fiberoptic Cable

The provided text is a letter from the FDA regarding a 510(k) premarket notification for an "Endoscopic Fiberoptic Cable." This document is a regulatory approval letter, not a study report or technical documentation that describes acceptance criteria, device performance, and study details.

Therefore, the information requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) cannot be extracted from the provided text.

The document primarily states that the FDA has reviewed the device and determined it is substantially equivalent to legally marketed predicate devices for the stated indications for use, thereby allowing it to be marketed. It does not contain the detailed technical performance data or study specifics you are looking for.

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The ISOLUX America's fiber optic cable is indicated for use in transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes and endoscopes, providing illumination in body cavities during examinations or surgical procedures.

Fiberoptic Cable

The provided document does not contain information about acceptance criteria, device performance, or any studies conducted. It is an FDA 510(k) clearance letter for a fiber optic cable, indicating it is substantially equivalent to previously marketed devices. Therefore, I cannot answer your request based on the provided text.

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