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Vessel Vapor™ is a gas conditioner accessory device intended to heat, humidify and filter an insufflating CO2 gas stream being used in minimally invasive cardiovascular, thoracoscopic, and vessel harvesting surgical procedures.

The Vessel Vapor™ 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 Vessel Vapor™ device consists of a disposable tubing set with a filter and heater/humidifier cassette and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the Vessel Vapor™ device, through the in-line filter, continues along the tube to enter the Vessel Vapor™ 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) summary for the Vessel Vapor™ device, a laparoscopic insufflator gas conditioner. It does not contain information about a clinical study with acceptance criteria and device performance. The document focuses on demonstrating substantial equivalence to predicate devices (Vessel Guardian® K102136 and Insuflow® K090456) based on technological characteristics and intended use.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), or training set information.

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Vessel Guardian®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 Vessel Guardian® 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 Vessel Guardian® 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 Vessel Guardian® device, through the in-line filter, continues along the tube to enter the Vessel Guardian® 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.

The provided text describes a 510(k) premarket notification for the "Vessel Guardian®" device, a laparoscopic insufflator gas conditioner. Instead of presenting a detailed study, the submission relies on the concept of "substantial equivalence" to predicate devices already on the market. Therefore, the information typically found in a study demonstrating device performance against acceptance criteria is not present in this document.

Here's an analysis based on the provided text, outlining why certain sections of your request cannot be fulfilled and what information is available:

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

This information is not provided in the document. The submission states: "Extensive performance testing has been conducted to assure that the Vessel Guardian® (i.e., Insuflow ) performs in accordance with its specifications and applicable standards." However, the specific acceptance criteria (e.g., target temperature ranges, humidification levels, filtration efficiency) and the quantitative results of this testing are not detailed.

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

This information is not provided. As the submission relies on demonstrating substantial equivalence rather than presenting an original clinical study with a test set, there are no details about sample sizes, data provenance, or whether data was retrospective or prospective.

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)

This information is not provided. Establishing ground truth is typically relevant in studies where diagnostic accuracy or similar performance is being evaluated against expert opinion. This document does not describe such a study.

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

This information is not provided. Adjudication methods are specific to clinical trials and diagnostic performance studies, which are not outlined here.

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

This information is not provided. An MRMC study is not relevant for this type of device, which is a physical accessory (gas conditioner) rather than an AI-driven diagnostic or assistive tool for human readers.

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

This information is not provided. This question is not applicable to a physical medical device like the Vessel Guardian®.

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

This information is not provided. Ground truth is not relevant in the context of this 510(k) submission, as it focuses on technological characteristics and equivalence rather than clinical outcomes or diagnostic accuracy requiring ground truth.

8. The sample size for the training set

This information is not provided. Training sets are relevant for machine learning algorithms, which are not described as part of this device.

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

This information is not provided. This question is not applicable for the reasons mentioned in point 8.

Summary of Available Information from the Document:

The core argument for the Vessel Guardian®'s safety and effectiveness is its substantial equivalence to predicate devices.

• Predicate Devices:

  • VasoVapor™, K101320
  • Insuflow®, K090456

• Claim of Equivalence: "Technically, the Vessel Guardian® is identical to the VasoVapor™ and Insuflow devices cleared for market in 510(k) K101320 and K090456, respectively. The indications for use for the Vessel Guardian® are patterned after the predicate devices, being specific to the endoscopic vessel harvesting application."

• Performance Testing (General Statement): "Extensive performance testing has been conducted to assure that the Vessel Guardian® (i.e., Insuflow ) performs in accordance with its specifications and applicable standards." However, the details of this testing, including specific acceptance criteria and results, are not included in the provided summary. The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent." This means the FDA found sufficient evidence in the full submission to support the claim of equivalence, which would include the performance testing mentioned, even if not detailed in this summary.

In conclusion, this document is a 510(k) summary focused on demonstrating substantial equivalence, not a detailed clinical study report. Therefore, most of the specific data points requested regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not present in this public summary.

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