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For illumination and irrigation/aspiration during surgery.

The American Medical Devices, Inc 19 and 20 ga. Endolight™ End Irrigating Endo-Illuminators are for illumination and irrigation during surgery. It consists of a stainless steel needle, delrin handpiece, PMMA fiberoptic fiber with plastic cladding, aluminum connector, and silastic tubing with luer lock connector. It connects to any conventional light source via an aluminum accessory adapter, which is packaged separately. This device also connects to any standard syringe with a male luer lock. The surgeon can then use the device to irrigate and aspirate while illuminating.

The provided text describes a premarket notification (510(k)) for the American Medical Devices, Inc., 19 and 20 Ga. Endolight™ End Irrigating Endo-Illuminator. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria.

This submission is focused on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing performance against specific acceptance criteria through a clinical or performance study. The core of this 510(k) is a comparison of design features, materials, and intended use with predicate devices.

Therefore, I cannot provide the requested information from the given text as it is not present. The document focuses on regulatory approval based on equivalence, not on a detailed performance study with acceptance criteria.

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