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E Surgical Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.

The E Surgical coated electrodes are designed as a standard stainless steel active electrode with a nonstick coating to prevent tissue and char build-up on the electrode. Three models: ball, needle, and blade are included.

The provided text describes a 510(k) summary for E Surgical Coated Electrodes. It outlines the device's indications for use, predicate devices, and a summary of its technological characteristics. However, the document primarily focuses on regulatory approval and substantial equivalence to predicate devices rather than a detailed study proving performance against specific acceptance criteria in the way a clinical study or robust scientific experiment would.

Therefore, much of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not explicitly stated in the provided 510(k) summary. The summary highlights safety and performance data in a general sense, aligning with regulatory requirements rather than providing a detailed study protocol and results.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and the reported device performance

The document lists "Safety and Performance Data" but these are presented as characteristics the device meets rather than clearly defined acceptance criteria with numerical performance targets and reported results against those targets.

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

• Sample size for test set: Not specified. The document does not describe a formal "test set" in the context of a clinical or comparative study. The listed performance data (e.g., coating bend test) likely refers to in-house testing, but the sample sizes for these tests are not provided.
• Data provenance: Not specified. Given the nature of a 510(k) summary focusing on substantial equivalence and general safety/performance, the data provenance for the internal tests is not detailed (e.g., country of origin, retrospective/prospective).

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

Not applicable. The document does not describe a test set requiring expert-established ground truth in a clinical or diagnostic context. The performance claims are based on engineering and material characteristic tests rather than diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. No clinical or diagnostic test set requiring adjudication 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

Not applicable. This device is an electrosurgical electrode, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

Not applicable. This device is an electrosurgical electrode and does not involve algorithms or AI for standalone performance evaluation in that context.

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

Not applicable in the conventional sense of diagnostic performance. The "ground truth" for the reported performance criteria would be:

• ANSI/AAMI HF 18: Compliance with the standard.
• Coating integrity: Visual inspection against cracking.
• Cutting/coagulation initiation: Likely observed by engineers or trained personnel during testing.
• Easy to clean properties: Subjective assessment or a defined cleaning protocol with a pass/fail criterion.
• Biocompatibility: Documentation/certification of meeting ISO 10993.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable, for the same reason as above.

In summary: The provided 510(k) document is a regulatory submission for substantial equivalence. It confirms the device meets general safety and performance requirements and is comparable to predicate devices but does not contain the detailed study protocols, sample sizes, expert involvement, or statistical analyses typically found in clinical studies or papers proving specific performance against quantitative acceptance criteria for diagnostic devices.

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