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Intended use: The monopolar electrosurgical pencil with electrode is used to deliver high frequency current to target tissue for cutting and coagulation.

Indication for use: The device is to be used in combination with a standard electrosurgical generator to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

Disposable electrosurgical pencil uses high density and high frequency current on local tissue thermal effect, the tissue or tissue components vaporization or burst, the medical operation so as to achieve the cutting and coagulation. Therefore, it may not only replace surgical knife for a variety of surgical procedures, and obviously reduce the bleeding or no bleeding. This can significantly reduce the labor intensity of the medical staff, and also shorten the operation time, and is good for patient to recover after surgery.

Disposable electrosurgical pencil is the applied parts of high frequency electrosurgical equipment/generator, when the high-frequency generator outputs a certain waveform of highfrequency current, which passes through the electrosurgical electrode and applies to the tissue of patient for cutting or coagulation, then the residual current returns back to the high-frequency generator through a neutral electrode.

The provided document is a 510(k) Summary for a Disposable electrosurgical pencil. It describes the device, its intended use, and a comparison to a predicate device, along with performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study conducted, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for each performance test with corresponding values. Instead, it states compliance with various standards. The "performance data" section describes the types of tests conducted and concludes that the device performed acceptably by meeting the requirements of recognized standards and guidance.

Here's a summary of the performance testing details:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for performance testing (Thermal Tissue Effects): The document states "Tissues of porcine kidney and porcine muscle were used for thermal effect testing." The specific number of samples (e.g., how many porcine kidneys or muscle pieces) is not provided.
• Data Provenance: Not explicitly stated. Given that Shenzhen Mecun Medical Supply Co., Ltd. is based in China, it's highly probable the testing was conducted there, but this is not confirmed in the document. The study is presented as performance testing for the subject device to demonstrate substantial equivalence, which implies it's prospective data for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not Applicable. The described study focuses on the physical performance of the electrosurgical pencil (e.g., thermal effects on tissue). It is a non-clinical performance study rather than a study involving human interpretation of data where "ground truth" would be established by experts (e.g., radiologists interpreting images). The "ground truth" here is the observable physical effect of the device on tissue under controlled conditions, measured instrumentally or visually by qualified personnel involved in the testing, but not explicitly as a panel of "experts" for ground truth establishment in the traditional sense of medical image analysis or diagnostic studies.

4. Adjudication Method for the Test Set

• Not Applicable. As explained above, this is a non-clinical performance study. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments, which is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance testing of the device itself, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. The device is a physical electrosurgical pencil, not a software algorithm or an AI system. Therefore, the concept of "standalone (algorithm only)" is not relevant.

7. The Type of Ground Truth Used

• For the performance testing on thermal tissue effects, the "ground truth" would be the physical and observable effects (cutting and coagulation characteristics, extent of thermal damage) on the porcine tissue, measured or observed directly during the test. This is an experimental observation under controlled conditions, not expert consensus, pathology, or outcomes data in the typical sense for a diagnostic device.

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI/ML algorithm or a software device requiring a training set. The performance testing involves direct physical testing of the electrosurgical pencil.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As mentioned above, there is no training set for this type of device.

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