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CONMED® Macrolyte® Dispersive Electrodes are designed for use with electrosurgical generators during electrosurgery and provide a path for, RF energy produced at the active electrode to return to the generator. The CONMED® Macrolyte® 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® Macrolyte® 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® Macrolyte® 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.

There are 9 models of the CONMED® Macrolyte® Dispersive Electrode.

The provided document is a 510(k) summary for the CONMED® Macrolyte® Dispersive Electrode. It details the device's description, intended use, and technological characteristics, and states that its safety and effectiveness are established by comparison to a predicate device.

However, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trials or performance validation reports.

Instead, it relies on the concept of "substantial equivalence" to a predicate device (CONMED® Macrolyte® Dispersive Electrode, 510(k) K100686), and conformance with recognized standards.

Therefore, I cannot populate the table or answer most of the questions using the provided text. I can only infer what information is not present.

Here's what I can glean or explicitly state based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

• Not provided in the document. The document states that "Questions of safety and effectiveness are the same for this device as they are for the predicated devices and other patient return electrodes on the market. There are no new technologies incorporated into the device." This implies that the acceptance criteria are implicitly met by being substantially equivalent to the predicate, rather than through a dedicated performance study with explicit metrics.

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

• Not provided in the document. There is no mention of a test set, sample size, or data provenance for a study proving acceptance criteria.

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

• Not applicable. No test set or ground truth establishment by experts is described for performance evaluation.

4. Adjudication method for the test set

• Not applicable. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This device is an electrosurgical dispersive electrode, not an AI-powered diagnostic device. Therefore, an MRMC study with human readers and AI assistance is not applicable.

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

• No. This device is hardware (an electrosurgical electrode), not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The type of ground truth used

• Not applicable. No specific ground truth is mentioned as the basis for performance evaluation beyond comparison to a predicate device and adherence to industry standards for electrosurgical equipment (IEC 60601-2-2) and biocompatibility (ISO 10993).

8. The sample size for the training set

• Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

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

• Not applicable. As above, no training set or ground truth establishment for it is mentioned.

Summary based on the provided text:

The document primarily focuses on establishing "substantial equivalence" to a previously cleared predicate device and conformity to relevant electrical and biocompatibility standards. It does not describe a new performance study with specific acceptance criteria that the device was tested against.

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CONMED® Macrolyte® Dispersive Electrodes are designed for use with electrosurgical generators during electrosurgery and provide a path for, RF energy produced at the active electrode to return to the generator. The CONMED® Macrolyte® 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® Macrolyte® 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® Macrolyte® 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. There are 9 models of the CONMED® Macrolyte® Dispersive Electrode.

The provided document is a 510(k) summary for a medical device called the CONMED® Macrolyte® Dispersive Electrode. It describes the device, its intended use, and general safety and performance information.

However, it does not contain any information regarding clinical studies, AI performance, or human reader effectiveness studies. The document focuses on demonstrating substantial equivalence to a predicate device through technological characteristics, biocompatibility testing (material selection and in vitro tests), and adherence to general safety standards (IEC 60601-2-2).

Therefore, I cannot provide answers to many of your questions as the information is not present in the given text.

Here's what can be extracted based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria for specific performance metrics of the device as it would for, say, an AI algorithm's accuracy. Instead, it refers to conformance with established standards for medical electrical equipment and biocompatibility.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable/Not provided. The listed performance testing refers to in vitro biocompatibility tests and adherence to engineering standards, not clinical performance or algorithmic evaluation.
• Data Provenance: Not applicable/Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable/Not provided. The ground truth for biocompatibility is established by adherence to ISO standards and in vitro test results, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This document is for a dispersive electrode, an electrosurgical accessory, not an AI-powered diagnostic device.

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

• Standalone Performance: No. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: For biocompatibility, the ground truth is established by the results of in vitro cytotoxicity, irritation, and hypersensitivity tests as per ISO 10993 standards. For electrical safety, the ground truth is adherence to IEC 60601-2-2.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not provided. There is no AI training set for this device.

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

• Ground Truth for Training Set: Not applicable/Not provided. There is no AI training set for this device.

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