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The LiNA SafeAir Smoke Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The SafeAir Smoke Pencil is a sterile single use integrated electrosurgical pencil and smoke evacuation hand piece that is packaged with an electrode blade. 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 integration of the electrosurgical pencil and smoke evacuation enables the operator to activate an electrosurgical current as well as capture the smoke plume simultaneously. The proposed device is the same as the predicate SafeAir Smoke Pencil. The only modification is a change to the labeling to allow the use of the Stryker® Colorado MicroDissection Needle electrodes in addition to the electrode that is packaged with the hand piece.

The provided document describes a 510(k) premarket notification for the LINA SafeAir Smoke Pencil, specifically focusing on a modification to the existing device. This modification is a labeling change to allow the use of additional electrodes (Stryker® Colorado MicroDissection Needle electrodes) with the previously cleared device. Therefore, the device in question is an electrosurgical pencil, and the study described is to confirm compatibility with new electrodes, not to establish foundational performance for the pencil itself.

Here's the information requested, based on the provided text:

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

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

The document does not explicitly state the sample size used for the compatibility testing. It mentions "Testing was performed," but provides no numerical details. The data provenance is non-clinical performance data, likely from laboratory testing. No information on country of origin is provided for the test data, and it is a prospective test specifically for this submission.

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

Not applicable. This was non-clinical performance testing for device compatibility, not a study involving human assessment or interpretation for ground truth establishment.

4. Adjudication method for the test set

Not applicable. As this was non-clinical technical testing, there was no need for expert adjudication.

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 document describes a 510(k) submission for a medical device (an electrosurgical pencil), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

No. This is a medical device, an electrosurgical pencil, not an algorithm.

7. The type of ground truth used

For the compatibility testing, the "ground truth" was objective technical measurements and functional verification against an established international standard (AAMI / ANSI / IEC 60601-2-2:2009, 201.15.4.1.102) and functional demonstration of current delivery.

8. The sample size for the training set

Not applicable. This is a physical 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 there is no training set for this type of device submission.

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