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The camera head has been designed to be used with Olympus endoscopes, camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

Both 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB and 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA are structurally consisted of endoscopic coupler end, camera cable and video connector end.

The 4K Camera Heads function as receiving optical image from a variety of endoscopes that are attached to it via coupler and using incorporated complementary metal oxide semiconductor (CMOS) image sensor to convert optical image into electronic signal. The signal is subsequently transformed into laser by laser diodes and input to VISERA 4K UHD CAMERA CONTROL UNIT by optical fiber for further processing with other ancillary equipment on endoscopic diagnosis, treatment, and observation.

This document is a 510(k) Summary for the Olympus 4K Camera Heads. It describes their equivalence to a predicate device and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of clinical performance or diagnostic accuracy. Instead, it focuses on non-clinical testing for design verification and validation against safety and performance standards.

Therefore, I cannot provide the requested information. The document asserts that the new devices are substantially equivalent to the predicate device due to similar indications for use, fundamental scientific technology, principle of operation, and energy source, with minor modifications (like additional sterilization methods) not raising new safety or effectiveness issues.

No information regarding acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth used (clinical), or training set details is present in the provided text.

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