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The OptiCLEAN Lens Irrigator is a disposable device to be used in combination with a 10 mm diameter scope to prevent dimming and fogging of the lens.
The OptiDOCK Tissue Ligator is a disposable device intended to pass an absorbable suture loop during endoscopic procedures.

The MedChannel OptiCLEAN Lens Irrigator is a single lumen endoscopic lens irrigator, designed for attachment to 10 mm diameter endoscopes. The irrigator comes in two sizes 285 mm or 305 mm, depending on surgeon's preference. The lens irrigator provides irrigation to the lens of an endoscope to prevent dimming and fogging of the lens during endoscopic surgical procedures.

The MedChannel OptiDOCK Tissue Ligator is a single use disposable suture passer, designed for use during endoscopic procedures. The OptiDOCK Tissue Ligator is pre loaded with PGA suture (USP 2-0).

The provided text is a 510(k) summary for the MedChannel OptiCLEAN Lens Irrigator and OptiDOCK Tissue Ligator. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices, describing the intended use, and listing the standards achieved (such as ISO 10993 for biocompatibility and AAMI 11135 for sterilization). It outlines the regulatory classification and the FDA's decision to clear the devices for marketing based on substantial equivalence.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and the study proving it, as that information is not present in the provided text.

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