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The New Deantronics E Green™ Electrosurgical Monopolar Pencils are intended to remove tissue and control bleeding by use of high-frequency electrical current.

The E Green™ Reusable Monopolar Cord is an electrosurgical accessory used with E Green™ Disposable Electrosurgical Pencil. Electrosurgical Pencils are intended to remove tissue and control bleeding by use of high-frequency electrical current. This product is a monopolar, electrosurgical pencil which is used for most open surgeries. The pencil can be divided in two parts, one is a gamma sterilized disposable electrosurgical pencil and another is a reusable cord which needs to be autoclaved by the user before use in a standard operating room environment. The E Green™ Reusable Monopolar Cord is used ONLY in combination with E Green™ Disposable Electrosurgical Pencil. The number of uses of the Reusable Monopolar Cord following steam sterilization is 100 times.

The provided document is a 510(k) premarket notification for a medical device: New Deantronics E Green™ Electrosurgical Monopolar Pencils. This document describes the device, its intended use, and substantial equivalence to a predicate device based on non-clinical testing. It does not contain information about a study involving expert readers assessing AI performance, human improvement with AI assistance, or data provenance, as would be typical for an AI/ML medical device submission.

Therefore, many of the requested elements (especially those related to AI/ML device studies like MRMC studies, training/test set details, expert ground truth establishment, and adjudication methods) cannot be extracted from this document, as it pertains to a traditional electrosurgical device.

However, I can extract information related to acceptance criteria and performance based on the non-clinical testing described.

Here's the breakdown of what can be extracted and what cannot:

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

The document states: "All the test results demonstrate the performance of New Deantronics E Green™ Electrosurgical Monopolar Pencil meet the requirements of its pre-defined acceptance criteria and intended uses." However, it does not provide a specific table listing the acceptance criteria and the numerical reported performance for each criterion. It only lists the standards to which the device was tested.

Table of Acceptance Criteria (Inferred from standards tested) and Reported Device Performance

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

• Sample Size: The document does not specify sample sizes (e.g., number of devices tested) for the non-clinical tests.
• Data Provenance: The tests are non-clinical, likely bench testing or lab testing to ensure compliance with standards. The company is based in Taiwan (New Deantronics Taiwan Ltd.). No mention of human patient data or its origin.

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)

• This information is not applicable and not present in the document. This is a traditional medical device, not an AI/ML device requiring expert-established ground truth from medical images or clinical data.

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

• This information is not applicable and not present in the document.

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, an MRMC study was not done. This device is not an AI/ML diagnostic tool.

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

• No, this is not an AI/ML algorithm. The performance evaluation is based on non-clinical testing against pre-defined standards for an electrosurgical pencil.

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

• For the non-clinical tests described, the "ground truth" would be compliance with the technical, safety, and performance specifications established by the listed international and national standards (e.g., IEC, ISO, AAMI, ASTM). There isn't a "ground truth" derived from patient data or expert consensus in the typical sense applied to AI/ML in diagnostics.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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