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The intended use for Söhniks Endoscopy, Inc.'s Cystoscopes are for examining, diagnosing, visualizing and to aid in treating the interior problems of the urether, prostate, bladder, and other urologic problems. This device is used m a visualization device and can be used in conjunction with other instruments to perform various diagnostic and therapeutic procedures.

The Söhniks Cystoscopes are reusable manually operated surgical devices that are provided in non-sterile and must be cleaned and sterilized by the user prior to use. The parts that contact the body are composed of surgical grade stainless steel, which has a long history of biocompatibility for human use.

Based on the provided text, there is no acceptance criteria and no study that demonstrates the device meets acceptance criteria.

The document is a 510(k) summary for a "Cystoscope," which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. The core of a 510(k) submission is to argue substantial equivalence, not to prove performance against specific acceptance criteria through a clinical study.

Here's why the requested information cannot be extracted from this document:

• Type of Document: This is an FDA 510(k) summary and approval letter. It focuses on regulatory approval based on "substantial equivalence" to existing devices, not on detailed performance studies with acceptance criteria.
• Content: The document describes the device, its intended use, device description, and claims substantial equivalence to predicate devices (e.g., "The basic design, materials and intended uses are the same and the device is constructed with the same materials as a [predicate device name, e.g., K023783], there are no new issues of safety and effectiveness."). It doesn't present data from a clinical trial or performance study against specific, quantified acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions because the provided text does not contain the information about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.

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