Search Results

Viewing of and access to, the surgical site during endoscopic gynecological surgical procedures

Modular Instrument System for Minimal Invasive Surgery. [Endoscope Accessories]

This is a 510(k) clearance letter for a medical device, not a study report. Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study details, or ground truth establishment.

A 510(k) clearance signifies that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. This process typically relies on comparisons to existing devices for safety and effectiveness rather than requiring new clinical trials or detailed performance studies like those described in the prompt for AI/diagnostic devices.

Therefore, I cannot provide the requested table and study details.

Ask a specific question about this device