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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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