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VasoVapor™ is a gas conditioner accessory device for use in endoscopic vessel harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.

The VasoVapor™ device is a single use device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation into the surgical cavity. The Vaso Vapor™ device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the VasoVapor™ device, through the in-line filter, continues along the tube to enter the VasoVapor™ device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to a gas entrance port or an insufflation needle/trocar and finally flows into the patient's surgical cavity.

This document is a 510(k) premarket notification for the LEXION Medical VasoVapor™ device, a laparoscopic insufflator gas conditioner. It claims substantial equivalence to previously cleared devices (Insuflow®, K063546 and K090456).

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

The document does not provide a table of acceptance criteria and reported device performance for the VasoVapor™ in this submission. Instead, it states that "Extensive performance testing has been conducted to assure that the VasoVapor™ (i.e., Insuflow®) performs in accordance with its specifications and applicable standards. Details of that testing were provided in 510(k) K063546 and K090456 are referenced in Section 5 for completeness."

Therefore, the performance data for VasoVapor™ is referred to previous 510(k) submissions, and is not detailed in this specific document.

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

The document does not provide information on the sample size used for a test set or data provenance for VasoVapor™. It refers to prior 510(k) submissions (K063546 and K090456) for details on performance testing.

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)

The document does not provide information about experts used to establish ground truth or their qualifications. The device is a gas conditioner accessory, and its performance would likely be assessed through physical and engineering tests rather than expert interpretation of medical images or data.

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

The document does not describe any adjudication method. This type of method is generally applicable for studies involving human interpretation (e.g., medical imaging) to resolve disagreements, which is not relevant for a device like a gas conditioner.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical data, often with or without AI assistance. The VasoVapor™ is an accessory device; not a diagnostic or screening tool.

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

A standalone performance evaluation (algorithm only) was not done, as the VasoVapor™ is a hardware device for conditioning gas, not an algorithm. Its performance would be measured by physical parameters (e.g., temperature, humidity, flow rate) rather than algorithm accuracy.

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

The document does not explicitly state the type of ground truth used. For a gas conditioning device, "ground truth" would likely refer to objective measurements of physical parameters such as temperature, humidity, and filtration efficacy, against established engineering specifications and standards.

8. The sample size for the training set

The document does not mention a training set sample size. A training set is typically relevant for machine learning algorithms, which are not applicable to the VasoVapor™ device.

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

The document does not mention a training set or how its ground truth was established, as it is not an AI/ML device.

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