Search Results
Found 2 results
510(k) Data Aggregation
(174 days)
Ask a specific question about this device
(71 days)
The Karl Storz SCB-RUI is intended for use by qualified surgeons and is used for central operation, central display, automatic initial setting, and interlocking operation of KSEA endoscopic devices.
The Karl Storz SCB-RUI is a remote control unit for KSEA endoscopic equipment.
The provided text is a 510(k) summary for the Karl Storz SCB-RUI, a remote control unit for endoscopic equipment. It states that the device is substantially equivalent to a predicate device and does not include any information regarding acceptance criteria, performance studies, sample sizes, expert determinations, or AI components.
Therefore, I cannot provide the requested information. The text does not describe a study to prove the device meets acceptance criteria, nor does it mention any performance metrics or AI involvement.
Ask a specific question about this device
Page 1 of 1