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The CarbonAid™ gas diffuser is intended for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism.

The CarbonAid™ gas diffuser is a disposable surgical device for effective insufflation of carbon dioxide (CO2) into an open surgical wound to create a topical atmosphere of 100% CO2. The larger tube transports the gas from the gas source/humidifier to the surgical wound and has the standard width of medical tubes for this purpose (14 inch). The hydrophobic gas filter (≤0.2µm) prevents cross-contamination between the aas source/humidifier and the wound. The thinner tube contains a stainless steel wire and stabilizes the gas diffuser inside the wound. The gas diffuser is made of medical foam plastic (with open cells, 30 kg/m3) that is connected to the thin tube via a plastic disc

This 510(k) submission for the CarbonAid™ gas diffuser does not contain the detailed acceptance criteria or the study data proving the device meets said criteria as requested.

The document states:

• "Sufficient data has been gathered from testing to assess that the CarbonAid gas diffuser performs as clinically intended." This is a general statement and does not provide specific performance data or acceptance criteria.
• The primary basis for clearance is substantial equivalence to a predicate device (Pall Medical Laparoshield Conditioned Insufflation Set; K030469), rather than a standalone performance study against pre-defined acceptance criteria. The document highlights that "Technologically, both the new device and the predicate device are the same (i.e. both are intended for the insufflation of carbon dioxide gas. Any differences between the two devices do not raise new questions of safety and effectiveness."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided text. The submission relies on establishing equivalence to a previously cleared device.

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