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Medline Circumcision Trays are intended for use by licensed physicians. The intended use of the medical products assembled in these kits will not be changed from the manufacturer's original intended use.

Medline Circumcision Trays are an assemblage of medical materials to be used by medical professionals during circumcision procedures. The trays will be assembled using Medline and other manufacturer's materials, medical devices and/or drugs. The devices are custom to our customers who specify the contents, quantity and placement of the individual items in the tray. The customer may also specific brand of similar items or minor variations of items. Medline intends to assemble these kits in a class 10,000 clean room or controlled environment and to sterilize using either EtO or gamma radiation at a contracted sterilization facility.

The provided text describes "Medline Circumcision Trays" and does not contain information about an AI/ML-driven device or diagnostic tool. Therefore, it's not possible to extract the requested details such as acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for such a device.

The document is a "Summary of Safety and Effectiveness" from 1997 for medical device clearance, focusing on demonstrating substantial equivalence for an assemblage of existing medical materials (circumcision trays). It discusses the components, intended use, and sterilization methods, but does not involve any AI/ML components or performance evaluation criteria in the context of diagnostic accuracy.

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