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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 handpiece. The device is designed for general electrosurgical applications 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 device is constructed of similar materials and design specifications as the predicate electrosurgical devices. The SafeAir Smoke Pencil combines the functions of electrosurgery and smoke evacuation into a single handpiece. The smoke evacuation orifice is located less than 1 cm from the electrosurgical blade to provide optimal smoke removal during cauterization. The smoke evacuation suction sleeve is adjustable to optimize the distance to the tip of the electrosurgical blade. As with the predicate GoldVac, the SafeAir Smoke Pencil is available in two (2) activation switch configurations, a rocker style and a push button style, which activate monopolar cut or coagulate functions. The device is connected to tubing using a dual connector to allow the user to connect to a variety of smoke evacuation systems including filtration or central vacuum systems, thus minimizing exposure of personnel to the surgical smoke plume. The device will be packaged singly for sterile distribution.

The provided document describes a 510(k) premarket notification for the SafeAir Smoke Pencil, an electrosurgical pencil with integrated smoke evacuation. The primary goal of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SafeAir Smoke Pencil are implied by its claim of substantial equivalence to predicate devices. This means its performance characteristics (electrosurgical function and smoke evacuation capability) should be comparable to or not adversely different from the predicate devices.

Study Information

1. Sample size used for the test set and the data provenance:

   • The document describes non-clinical testing on Simulated Tissue. The specific sample size for this testing is not provided.
   • The testing was performed by "LiNA Medical ApS" (the sponsor), which is a Danish company, suggesting the data provenance is likely European, possibly Danish, although no explicit country of origin is stated for the test data itself.
   • The study is a prospective test in the sense that the testing was conducted specifically for this 510(k) submission to demonstrate performance of the new device.

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

   • This question is not applicable as the testing was non-clinical and conducted on simulated tissue. There was no ground truth that needed to be established by human experts in the context of diagnostic interpretation. The ground truth was based on physical measurements of electrosurgical effect and smoke evacuation.

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

   • This question is not applicable as the testing was non-clinical and did not involve human interpretation or adjudication of results in the traditional sense. Performance was evaluated based on objective measurements and compliance with engineering standards.

4. 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 comparative effectiveness study was not done. This device is a surgical tool, not an AI-assisted diagnostic device, so such a study would not be relevant.

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

   • Yes, standalone performance testing was done. The document states: "The LiNA SafeAir Smoke Pencil has been shown to perform as intended with the equivalent results as the predicate devices through simulated tissue cauterization and cutting functions... The SafeAir Smoke Pencil passed all testing and results were consistent with the intended use of the device." (Section 9 & 10) This refers to the physical and functional performance of the device itself, without human-in-the-loop performance in the sense of a diagnostic interpretation.

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

   • The ground truth for the non-clinical performance testing was based on engineering and performance metrics for electrosurgical cutting and coagulation effectiveness, smoke evacuation capability (e.g., airflow, smoke capture), and compliance with international standards (ISO 10993, IEC 60601-1, IEC 60601-2-2). It's essentially "physical proof" that the device performs its intended functions and meets safety standards, rather than a diagnostic ground truth.

7. The sample size for the training set:

   • Not applicable. This device does not involve AI or machine learning algorithms that would require a training set.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for an algorithm, there is no ground truth for a training set to be established.

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