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The Lexion Medical Insuflow® device is an accessory to an insufflator intended to heat, humidify and filter a gas stream used for inflation during laparoscopic surgery.

The Insuflow® device is a single use device that attaches to the outlet port of an insufflator and is designed to warm and humidify the gas stream prior to insufflation into the abdominal cavity. The Insuflow® device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system.

Gas from the insufflator flows into the Insuflow® device, through the in-line filter, continues along the tube to enter the Insuflow® device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to a trocar or insufflation needle, and finally flows into the patient's abdomen.

The provided text is a 510(k) summary for the Lexion Medical Insuflow® Device. This document is a premarket notification for a medical device and describes its equivalence to a previously marketed device (predicate device), rather than presenting a study that establishes acceptance criteria and then proves the device meets those criteria from an AI/ML perspective.

Therefore, the requested information, which pertains specifically to performance metrics, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training data for AI/ML models, cannot be extracted from this document, as it is not relevant to the type of device and the submission presented.

The device described is a physical accessory to an insufflator that heats, humidifies, and filters gas for laparoscopic surgery. The studies mentioned are primarily focused on system performance (CO2 gas temperature and humidity characteristics), electrical safety, EMC testing, and biocompatibility. These are engineering and biological performance characteristics, not AI/ML model performance metrics.

Specifically, for each point requested:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document mentions "The Insuflow® device met all specified design and performance requirements" for electrical safety and EMC, and "All specified biocompatibility requirements were met." However, it does not provide a table of these specific criteria or quantitative performance results in a way that would be comparable to AI/ML model output (e.g., sensitivity, specificity, AUC).
2. Sample sizes used for the test set and the data provenance: Not applicable. The studies mentioned (system performance, electrical safety, biocompatibility) are laboratory or bench tests, not clinical studies with "test sets" in the AI/ML sense. Data provenance is not specified beyond being "verification testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's engineering and biocompatibility performance is typically established by engineering standards, chemical analysis, and certified test protocols, not expert consensus in the diagnostic sense.
4. Adjudication method for the test set: Not applicable. There is no "test set" and thus no adjudication method as understood in AI/ML performance evaluation.
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: Not applicable. This device does not involve human "readers" or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the tests performed would be established by engineering specifications, validated measurement equipment, and standardized biological assessments.
8. The sample size for the training set: Not applicable. There is no AI/ML model to train.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided K063546 document for the Insuflow® device does not describe an AI/ML device and therefore the requested information fields related to AI/ML model performance and validation are not present.

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