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The use for this particular device is to be worn on the surgeons head and to illuminate the body cavity during examinations or surgical procedures. This product is shipped to the end user non-sterile.

Surgical Headlight

This is a 510(k) premarket notification for a Surgical Headlight. The provided document is a letter from the FDA determining substantial equivalence to a legally marketed predicate device. It does not contain information about acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information. The document is solely an administrative approval letter based on equivalence to existing devices, not a performance evaluation.

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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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