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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. 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 document is a 510(k) summary for the CONMED® Surefit™ Dual Dispersive Electrode. It describes the device, its intended use, and indicates that its technological characteristics are identical to a predicate device (K100047). The document refers to "Performance Testing" in section K, stating that specific testing performed was in conformance with the requirements of IEC 60601-2-2:2009 Edition 5.0, ISO 10993-5:1999, and ISO 10993-10:2002/Amd 1:2006.

However, the document does not describe acceptance criteria or the specific results of a study that proves the device meets those criteria. It only mentions the standards followed for performance testing and biocompatibility.

Therefore, many of the requested details cannot be extracted from this document, as they are not present.

Here's a breakdown of what can be inferred or what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of specific thresholds or pass/fail conditions for device performance. The document only lists the standards followed (IEC 60601-2-2, ISO 10993-5, ISO 10993-10). These standards contain general requirements and test methods for electrosurgical equipment and biological evaluation of medical devices, which would implicitly define acceptance criteria (e.g., no excessive heating, no cytotoxicity, no irritation). However, the specific "acceptance criteria" for the CONMED® Surefit™ Dual Dispersive Electrode as a device are not detailed in this summary.
• Reported Device Performance: Not reported. The document states that testing was "in conformance with the requirements" of the listed standards, implying successful performance, but it does not provide any quantitative or qualitative results of these tests.

2. Sample size used for the test set and the data provenance

• Not explicitly stated. The document refers to "specific testing performed" but does not give sample sizes for any tests.
• Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not mentioned. This document describes the testing of a medical device (electrode), not an AI algorithm or diagnostic tool where expert ground truth would typically be established. The "ground truth" for this device would be its physical and electrical performance against established standards.

4. Adjudication method for the test set

• Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple readers. This is not a clinical study of that nature described in this summary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• No, this is not indicated. MRMC studies are relevant for diagnostic or AI-assisted interpretation, which is not the subject of this 510(k) summary.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a physical medical device (electrode), not an algorithm.

7. The type of ground truth used

• For a device like this, the "ground truth" would be objective measurements against engineering specifications and international standards (e.g., electrical impedance, temperature rise, biocompatibility test results). The document states testing was "in conformance with the requirements of the following standards" (IEC 60601-2-2, ISO 10993-5, ISO 10993-10). The "ground truth" is therefore implicitly defined by the pass/fail criteria within these standards.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

• Not applicable, for the same reason as above.

In summary, this 510(k) document is a regulatory submission for a medical device that details its equivalence to a predicate device and adherence to relevant standards for safety and performance (biocompatibility and electrical safety). It does not provide a detailed "study that proves the device meets the acceptance criteria" with specific performance metrics and sample sizes, as would be expected for a complex diagnostic AI device. Most of the requested information pertains to clinical or AI algorithm validation studies, which are not described here.

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