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Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964. The equipment is a drive unit for use in dental surgery, implantology, maxillo-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation

The implantMED SI-915/923 consist of a small hand held motor, a foot control and a controller. Accessories complete the device. They are designed for use in dental surgery. Optimum irrigation of the treatment site is an important factor for successful treatment. An integrated pump is used to supply the treatment fluid / coolant from its reservoir via a pump to the motor / handpiece.

The provided text is a 510(k) summary for the implantMED SI-915/923. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document is purely a regulatory submission outlining the device's characteristics and its equivalence to a previously cleared device (K002469). It asserts that "The technological characteristics are very similar to the old device" and that "Comparisons of the subject and the previous version show similar technological characteristics, performance properties and biocompatibility." This statement implies that performance testing was conducted, but no details of such testing, acceptance criteria, or results are provided in this regulatory summary.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance study data based on the provided text.

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