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E-Z Clean electrosurgical electrodes are intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.

Some tip configurations have a specific geometry that minimizes blanching and thermal damage in skin incisions when used in conjunction with the generator's Advanced Cutting Effect (ACE) mode.

The Megadyne E-Z Clean electrosurgical electrode is a monopolar electrosurgical electrode that is coated with polytetrafluoroethylene (PTFE). It is insulated over the majority of its exposed length. It is intended for general electrosurgical use, and is designed to fit into and work in conjunction with an industry standard hand- or footactivated electrosurgical pencil which is connected to an electrosurgical unit or ESU. This device is supplied sterile and is not intended to be reused.

The E-Z Clean electrosurgical electrodes are available in a number of tip configurations and lengths. Tips such as standard blades, modified blades, needles, blunt needles, ball-ends, and others are typical.

Some tip configurations (ACE blades) contain a slightly different geometry that will enhance the affects of the generator's Advanced Cutting Effect (ACE) Mode. In this mode, the blade will make skin incisions without the blanching or thermal damage commonly seen with standard electrosurgery. The new E-Z Clean ACE Blade provides a wound site that will heal similar to a scalpel wound (comparable Histopathology) when used in conjunction with the ACE mode. When not being used to perform skin incisions the ACE Blade functions as a standard E-Z Clean blade in all cutting and coagulating modes.

This submission also includes the option of a guard or nosecone on some configurations of electrodes. This nose cone provides additional dielectric protection at the junction where the E-Z Clean electrosurgical electrode is connected to an electrosurgical pencil.

The provided text is a 510(k) summary for the Megadyne E-Z Clean electrosurgical electrodes. It describes the device, its intended use, and its technological characteristics. However, it does not contain any information about a clinical study with acceptance criteria and reported device performance.

The document states that "Questions of safety and effectiveness are the same for this device as they are for the predicate devices and other electrosurgical electrodes on the market. There are no new technologies incorporated into the device." This implies that the device's safety and effectiveness are established through substantial equivalence to existing predicate devices, rather than a new clinical study.

Furthermore, it mentions extensive testing for conformance to voluntary standards (ISO 60601-2-2:2006 and ANSI / AAMI HF 18-2001), which are primarily engineering and safety standards, not clinical performance studies with specific patient outcomes or effect sizes.

Therefore, I cannot provide the requested information because it is not present in the provided text.

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