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Intended Use: Sutter Bipolar Forceps - Calvian are intended to remove tissue and control bleeding.

Sutter Bipolar Forceps - Calvian is an electrosurgical tool available in different handle styles and tip sizes. It is constructed with medical grade stainless steel, coated with Polyamide PA 11 as electrical insulator and possesses tips made of stainless steel that are partly not insulated. The forceps can be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. As an electrosurgical accessory it is intended to remove tissue and control bleeding. The maximum peak voltage to use the forceps is 500 Vp. The forceps are provided non-sterile, are reusable and must be sterilized prior initial and subsequent use.

This is a 510(k) premarket notification for a medical device (Sutter Bipolar Forceps - Calvian), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets them in the context of AI/ML, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable and cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to a predicate device based on design, materials, intended use, and adherence to relevant standards for electrosurgical cutting and coagulation devices.

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