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The PLUMEPEN 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.

Indications for use for PLUMEPEN® Integrated Smoke Evacuation Pencil include:

• To remove smoke plume from the surgical site a.
• b. To remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect

The PLUMEPEN Integrated Smoke Evacuation Pencil is a sterile, single use integrated electrosurgical pencil and smoke evacuation handpiece. The device is intended for general electrosurgical applications and when used in conjunction with an effective smoke evacuation system, for removing smoke generated by electrosurgery.

The device is constructed using the same materials and design specifications commonly found in the predicate devices in the electrosurgical marketplace. The device is designed to integrate smoke evacuation into electrosurgery by combining both features into a single handpiece. The integrated smoke evacuation pathway is located above the electrosurgical blade to capture the smoke plume created during cauterization. The extendable channel allows for adjustment of the capture position to accommodate a variety of different style and length electrosurgical blades. There are two (2) buttons on the device, which activate monopolar cut or coagulate. The pencil is connected to tubing which will be attached to a variety of smoke evacuation systems. The smoke is then filtered by the smoke evacuation system to limit personnel exposure to the hazards associated with surgical smoke plume. The device will be packaged singly for sterile distribution.

This 510(k) summary describes a medical device called the PLUMEPEN® Integrated Smoke Evacuation Pencil, which combines electrosurgery and smoke evacuation functions. The submission aims to demonstrate its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define specific quantitative acceptance criteria (e.g., minimum smoke capture efficiency, maximum temperature rise, specific electrical performance thresholds) for the PLUMEPEN. Instead, it relies on the concept of "substantial equivalence" to predicate devices.

The reported device performance is described generally as:

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

The document explicitly states: "Bench testing on the subject device has shown the device to perform as intended with the same or similar results as a predicate device."

• Sample Size for Test Set: Not specified. The document only mentions "the subject device" (singular), implying that perhaps one or a few units were tested to demonstrate performance. There is no information on the number of individual tests or repetitions performed.
• Data Provenance: The testing was "bench testing," meaning in a laboratory setting. There is no information provided about the country of origin of data or whether it was retrospective or prospective. It is a non-clinical study.

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

This information is not provided. The study described is a non-clinical bench test, not one that would typically involve human expert interpretation for ground truth establishment in the way, for example, an imaging diagnostic algorithm would.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As it was a non-clinical bench test, an adjudication method for a test set based on expert consensus would not be relevant. The "ground truth" (or performance standard) appears to be derived from the expected function of electrosurgical pencils and smoke evacuation systems, and comparison to predicate devices, rather than expert adjudication of clinical outcomes or images.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive AI systems where human readers evaluate cases. The PLUMEPEN is an electrosurgical tool, and its evaluation focuses on its physical and functional performance, not its impact on human reader performance.

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

The entire "Performance Testing" section describes standalone non-clinical bench testing of the device's physical and functional attributes. The device itself does not contain an "algorithm" in the sense of an AI system. The testing evaluated its capacity for electrosurgery and smoke evacuation.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing appears to be based on:

• Functional expectations: The device should perform cutting, coagulation, and smoke evacuation effectively.
• Comparison to predicate devices: The device should perform "with the same or similar results as a predicate device," and be "as safe and performs as well as or better than" them.
• Compliance with recognized standards: Adherence to IEC 60601-2-2 and ISO 10993.

There is no mention of pathology, clinical outcomes data, or expert consensus in the typical sense of evaluating a diagnostic or therapeutic outcome.

8. The Sample Size for the Training Set

This information is not applicable/provided. The PLUMEPEN is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

This information is not applicable/provided for the reason stated in point 8.

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To remove airborne particles generated by tissue combustion during laparoscopic surgery, via filtration of gaseous media contained within the distended pneumoperitoneum in order to significantly improve visualization.

LapEvac may be used in any laparoscopic surgery, as appropriate.

Sterile, single use only device

LapEvac is a battery operated smoke evacuation system that connects directly to the inlet and outlet cannula/ trocars and creates a continuous closed circuit for filtering pneumoperitoneum gaseous media (typically CO2). The system contains the LapEvac unit and connection tubing. Filtration is accomplished using activated charcoal filtration media and ULPA filtration media. The system filters and recirculates at an approximate rate of 4 liters per minute. Operating life is approximately 4 hours. A 3 amp, UL rated slide switch provides on/off control.

The provided text describes bench verification tests for the LapEvac device rather than a comprehensive study with acceptance criteria and specific performance metrics in the format requested. The document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a predicate device through various tests.

Based on the provided text, the following information can be extracted, and where information is not available, it is noted:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document states "Three sets of bench verification tests were conducted," but does not detail the number of runs, devices, or data points for each test.
• Data Provenance: The tests were "bench verification tests," implying they were conducted in a laboratory setting, likely in the US (given the US company address and FDA submission). The document does not specify if the data was retrospective or prospective, but as it's for a new device's premarket notification, it would be prospective data gathered specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable. The tests performed are bench verification tests evaluating physical characteristics and performance of the device (smoke clearing time, pressure, temperature, humidity, battery life), not diagnostic assessments requiring interpretations from medical experts.
• Qualifications of Experts: Not applicable for this type of testing.

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

• Adjudication Method: Not applicable. As mentioned above, these are bench tests measuring physical properties, not evaluations requiring human adjudication of medical findings.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a smoke evacuation system, not an AI-powered diagnostic tool. The "Clarity of View and Evacuation Efficiency" test compares the device's ability to clear smoke to "smoke filtration devices commonly used during laparoscopic surgeries" but does not involve human readers/interpreters or AI.

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

• Standalone Performance: The described tests reflect standalone performance of the device (the "algorithm" in this context being the device's physical mechanism of filtration and recirculation). The device functions independently to clear smoke.

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

• Type of Ground Truth: The ground truth for these bench tests would be various established physical and engineering standards. For example:
  • Clarity of View and Evacuation Efficiency: Comparison to the performance of "commonly used smoke filtration devices" (implied industry standard or predicate device performance data).
  • Effect on Pneumoperitoneum: Expected physiological ranges for pressure, temperature, and humidity within a pneumoperitoneum.
  • Power Budget: The manufacturer's specified operating life of "approximately 4 hours."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable. As this is not an AI/ML device, a training set and its associated ground truth establishment methods are irrelevant.

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