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The irrigation tubing set is an accessory to dental surgical units. The irrigation tubing set is used to supply treatment fluid from the reservoir to the handpiece via a pump.

elcoMED SA-200, elcoMED SA-200 C and implantMED SI-95 consist of fa elcoMED SA-200, elcoMED OA 200 control and a controller. They are designed for use in dental surgery. Optimum irrigation of the treatment site is an important factor for successful Oplinium imgation of the treatment one 10 all of all and its reservoir via a pump to the motor / handpiece.

The provided text describes a 510(k) summary for an irrigation tubing set and Y-switch. It does not contain information about acceptance criteria, detailed device performance metrics beyond a statement of substantial equivalence, or any study details that would typically be associated with AI/ML device testing (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The document is a regulatory submission demonstrating substantial equivalence to a predicate device, focusing on intended use and technological characteristics rather than detailed performance study results against specific acceptance criteria.

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