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The 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 smoke plume simultaneously. The SafeAir Smoke Pencil is available in two activation switch configurations, a rocker style and push-button style, which activate monopolar cut or coagulate functions. The pencil is connected to smoke evacuation tubing which features a dual connector (8 and 22 mm) 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 surgical smoke plume. Electrodes are available in either 70 mm blade or 70 mm coated blade configurations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SafeAir Smoke Pencil:

The document provided is a 510(k) summary for a medical device, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This type of submission typically focuses on demonstrating "substantial equivalence" rather than presenting a full clinical trial with acceptance criteria for new device performance. Therefore, the information provided isn't structured to detail specific acceptance criteria for diagnostic performance or a study proving those criteria in the way one might expect for a diagnostic AI device.

Instead, the document focuses on non-clinical performance testing to demonstrate the safety and effectiveness of the modified device in comparison to a predicate device. The "acceptance criteria" can be inferred from the types of tests performed and the statement that "results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the SafeAir Smoke Pencil and electrodes are sufficient for their intended use and support a determination of substantial equivalence."

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the document (a 510(k) summary for a modified electrosurgical pencil), explicit numerical acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity) are not provided, as this is not a diagnostic device. The "acceptance criteria" here relate to engineering performance, biocompatibility, and sterility.

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

The document does not describe a "test set" in the context of diagnostic AI (i.e., a dataset of cases used to evaluate an algorithm's classification performance). The testing described is non-clinical performance testing of the device itself.

• Sample Size: Not specified for individual non-clinical tests (e.g., how many pencils were tested for electrical safety, or how many materials for biocompatibility). The focus is on demonstrating compliance with standards and equivalence.
• Data Provenance: Not applicable in the context of clinical data provenance. The testing was performed on samples of the device itself.

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

Not applicable. This device is not an AI diagnostic device that requires expert-established ground truth for a test set. The validation pertains to physical and electrical properties, and biological safety.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" of clinical cases requiring adjudication.

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

No. An MRMC comparative effectiveness study is designed for evaluating diagnostic devices, typically AI, and their impact on human reader performance. This device is an electrosurgical tool, not a diagnostic one.

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

No. This is not an AI algorithm. The device itself is a standalone medical instrument.

7. The Type of Ground Truth Used

The concept of "ground truth" as used in diagnostic AI is not applicable here. The "truth" for the non-clinical tests refers to compliance with established engineering standards (e.g., ISO 60601-1 for electrical safety, ISO 11135-1 for sterilization) and biocompatibility standards (ISO 10993-1).

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no training set.

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

Not applicable. There is no training set for an AI algorithm.

Summary of the Document's Focus:

This 510(k) submission is for a modification and line extension of an existing electrosurgical device (the SafeAir Smoke Pencil). The goal is to demonstrate "substantial equivalence" to a predicate device (K142538) by showing that the changes (electrode connector material, added accessories, pre-mounted components, and a new coated blade electrode) do not alter the intended use, indications for use, or fundamental scientific technology, and do not raise new questions of safety or effectiveness.

The "study that proves the device meets the acceptance criteria" refers to a battery of non-clinical performance tests covering:

• Biocompatibility (meeting ISO 10993-1)
• Sterilization validation (meeting ISO 11135-1 with a SAL of 10⁻⁶)
• Electrical safety (meeting ISO 60601-1 and 60601-2-2)
• Integrity and functionality after aging
• Thermal spread testing

The acceptance criteria for these tests are implicitly the successful demonstration of compliance with the relevant standards and the assurance that the device's performance is equivalent to, or better than, the predicate device. Specific numerical results for each test are not detailed in this summary document, but the conclusion states that the "results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness... are sufficient for their intended use and support a determination of substantial equivalence."

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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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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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