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The Karl Storz Rigid Telescopes for Obstetrics and Gynecology and their predicate devices are designed to allow viewing of the site during laparoscopic and hysteroscopic surgical procedures.

The Karl Storz devices are straight-shafted, rod lens-type rigid telescopes. All body contact materials are commonly used in medical devices for a wide range of applications, and have a long history of biocompatibility for human use.

The provided text is a summary of safety and effectiveness for Karl Storz Rigid Telescopes for Obstetrics and Gynecology, a medical device. This document is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device.

The information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is typically found in detailed clinical trial reports or validation studies for AI/machine learning medical devices. The provided text does not contain any of these details.

The document states: "The Karl Storz Rigid Telescopes for Ob/Gyn are substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the Karl Storz Rigid Telescopes for Ob/Gyn and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices."

This indicates that the device's acceptance was based on showing equivalence to existing, approved devices, not necessarily on meeting new, specific quantitative performance criteria through a standalone study as would be described for an AI/ML device.

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, sample sizes, ground truth definitions, or information about AI performance, as this information is not present in the provided text. The document is from 1996 and describes an optical instrument, not an AI-powered diagnostic or therapeutic device.

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