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The AirSeal® dV Solution, AirSeal Cannula Cap and AirSeal Bifurcated Filtered Tube Set, is intended for use in diagnostic and/or therapeutic endoscopic procedures in conjunction with the ConMed AirSeal iFS and an Intuitive da Vinci Xi and da Vinci X Cannula to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstructionfree path of entry for endoscopic instruments, and to evacuate surgical smoke.

It is indicated for use in abdominal, thoracic, and pediatric (≥ 20kg) procedures where insufflation is desired to facilitate the use of various laparoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. The obturator of the Cannula Cap is indicated for use with or without visualization.

The AirSeal Cannula Cap and Bifurcated Filtered Tube Set must be used with the Intuitive da Vinci X 8 mm Instrument Cannula, an Inturtive Cannula Seal and the AirSeal mode. When used in AirSeal mode, the Cannula Cap and Bifurcated Tube Set are designed to provide CO2 gas delivery with stable pneumoperitoneum and continuous smoke evacuation during robotic assisted laparoscopic procedures using the da Vinci Xi or da Vinci X systems. The Bifurcated Filtered Tube Set is used to connect the Cannula Seal to the AirSeal iFS.

The ConMed AirSeal dV Solution consists of the following major components: (1) AirSeal® Cannula Cap with a cannula cap and an obturator, and (2) AirSeal® Bifurcated Filtered Tube Set. The cannula cap, obturator and tube set are sterile, single-use products. The AirSeal dV Solution, in conjunction with Intuitive daVinci Xi\X Cannula and Cannula Seal, is operated in the Airseal Mode with the AirSeal iFS System to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. The ConMed AirSeal dV Solution is a sterile, single use device, primarily composed of polycarbonate, polypropylene, and stainless steel.

The provided text is a 510(k) premarket notification for a medical device (AirSeal dV Solution). It describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical performance data.

However, it does not contain information about a study that proves the device meets specific acceptance criteria based on numerical performance metrics tied to AI or algorithmic detection, human reader improvement, or detailed ground truth establishment. This document focuses on demonstrating substantial equivalence to a predicate device through:

• Indications for Use Comparison: Showing similar intended use.
• Technological Characteristics Comparison: Highlighting similarities in product code, gas flow, pressure, smoke evacuation levels, and use environment, while noting differences like cannula inner diameter and system components that are accounted for through testing.
• Non-Clinical Performance Data: Biocompatibility, shelf-life, and benchtop testing (penetration force, flow rate, pressure/leak testing).

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text. The questions seem to be geared towards an AI/ml device study, which is not what this document describes.

Here's what I can extract based on the provided text, and where the information is missing for your specific request:

Acceptance Criteria and Reported Device Performance (Table)

Missing Information/Not Applicable to this Document Type:

1. Sample size used for the test set and the data provenance: Not applicable. The document describes benchtop testing and biocompatibility, not clinical data or a "test set" in the context of an AI/ML study.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical outcomes is not established in this document.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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, an MRMC study was not described. This is not an AI/ML device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. The "ground truth" here is engineering specifications and standardized biological tests.
7. The sample size for the training set: Not applicable; there is no AI/ML training set.
8. How the ground truth for the training set was established: Not applicable.

In summary, this document details a 510(k) submission for a medical device that facilitates laparoscopic procedures, not an AI/ML diagnostic or prognostic tool. The "acceptance criteria" here relate to engineering performance, material safety (biocompatibility), and shelf-life, rather than clinical efficacy or diagnostic accuracy derived from a data-driven model.

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