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CONMED® Surefit™ Dual Dispersive Electrodes are designed for use with only those electrosurgical generators equipped with contact quality monitoring systems (i.e. REM™, ARM™, and NESSY, ™etc.) during electrosurgery and provides a path for, RF energy produced at the active electrode to return to the generator. The Surefit™ Dual Dispersive Electrode is for use with all patient populations providing there is sufficient surface area to ensure full contact of the electrode with the patient's skin.

The CONMED® Surefit™ Dual Dispersive Electrode is a single use, non-sterile dispersive electrode with a pre-attached cord. The purpose of the return electrode is to complete the electrosurgical circuit between the generator, the active electrode, and the patient. The CONMED® Surefit™ Dual Dispersive Electrode is to be used on any patient where full skin contact and a suitable placement site can be obtained. Use of this product for unintended applications could lead to an unsafe condition.

The surface of the conductive area is covered with a soft, conformable hydro-gel conductive adhesive. The pad also has a non-conductive border adhesive surrounding the entire conductive area to isolated the conductive area from surgical fluids.

The provided text is a 510(k) summary for a medical device called the CONMED® Surefit™ Dual Dispersive Electrode. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance results in the context of an AI/ML model for diagnostic or predictive purposes.

Therefore, the specific information requested in the prompt regarding acceptance criteria, studies, sample sizes, expert involvement, and ground truth for an AI/ML model is not present in this document.

However, I can extract the information related to the device's assessment methods:

Acceptance Criteria and Device Performance:

Since this is a submission for a dispersive electrode, the "acceptance criteria" discussed are related to meeting established standards for electrosurgical accessories, rather than performance metrics like sensitivity or specificity for an AI model.

Explanation of Missing Information:

• Sample sized used for the test set and the data provenance: Not applicable. The document describes compliance with standards, not a test set for an AI model.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/ML diagnostic or predictive device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable in the context of an AI/ML model. The "ground truth" here is the adherence to established engineering and biocompatibility standards.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Key takeaway: This document is a regulatory submission for a medical device that relies on established engineering and biocompatibility standards for its safety and effectiveness, not on an AI/ML model that would have the types of studies described in the prompt. The "acceptance criteria" are therefore compliance with these standards.

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