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The PenEvac® is intended to be used as the active Monopolar electrosurgery generator system and to facilitate the removal of smoke that is generated during procedures.

The Non-Telescopic PenEvac is defined as monopolar electrosurgical pencil with smoke evacuation capabilities. The device is designed for general electrosurgical applications including cutting and coagulating and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

The Non-Telescopic PenEvac is intended to be used by trained professionals and will be marketed as a single use device, having different configuration as far as: type of electrode, length of tubing and end connector.

The proposed device is the same as the predicate Telescoping PenEvac. The only modification is a change in the telescopic tip, as the Non-Telescopic PenEvac does not have the telescope capability.

The provided text describes a 510(k) premarket notification for a medical device called "Non-Telescopic PenEvac." This document focuses on demonstrating the device's substantial equivalence to a predicate device, the "Telescoping PenEvac" (K954088), rather than presenting a performance study with detailed acceptance criteria and results in the way typically seen for novel devices or AI/software.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
The acceptance criteria are not specified with numerical thresholds in this document, but rather refer to compliance with internationally recognized medical device safety and performance standards (IEC 60601 series). The reported performance is a general statement that the device met these criteria. This type of presentation is common for 510(k) submissions where the device is a modification of an already cleared product and the primary goal is to show "substantial equivalence."

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

The provided text only mentions "Performance Testing-Bench" and explicitly states there was no clinical testing required. Therefore, there is no sample size for an in-human test set or data provenance related to clinical data. The bench testing would have involved physical samples of the device, but the number of units tested is not specified.

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

Not applicable. Since no clinical testing was performed and the study focused on bench testing against IEC standards, there was no need for expert ground truthing of clinical data.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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

No. An MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical testing required." This type of study is relevant for diagnostic devices or AI systems where human reader performance is being evaluated or compared, which is not the case here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The "Performance Testing-Bench" described is a standalone evaluation of the device's physical and electrical characteristics against predefined standards, without human interaction beyond operating the device for the test. However, this is not an "algorithm-only" performance as the device itself is a physical electrosurgical pencil, not primarily software/AI.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" was established by the requirements and acceptance criteria defined within the IEC 60601 series of standards. These standards stipulate acceptable ranges for electrical safety, electromagnetic compatibility, and specific performance characteristics of high-frequency surgical equipment.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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