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The CarbonAid® CO2 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 which can result in organ damage.

The CarbonAid®CO2 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 during open heart surgery. Air will enter in the heart and great vessels during conventional open heart surgery and is difficult to evacuate with current de-airing techniques. Trapped air will be mobilized to the arterial vessels during weaning from cardiopulmonary bypass and will thus embolize to the brain and other organs. Since air dissolves poorly in blood and tissue, air bubbles will obstruct blood flow and cause tissue hypoxia and injury. CO2 is more than 25 times more soluble than air in blood and tissue and arterial CO2 emboli will thus be fewer, dissolve more quickly and decrease the risk of organ injury. A 100% CO2 atmosphere can be created and maintained in an open surgical wound, since CO2 is 50% heavier (denser) than air, provided that tube transports the CO2 gas from the gas source/humidifier to the surgical wound and has the standard width / internal diameter of medical tubes for this purpose (¼ inch). The hydrophobic gas filter (pore size

The provided text is a 510(k) Pre-market Notification for a medical device, the "CarbonAid® CO2 diffuser." This type of document is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than to prove its effectiveness against specific acceptance criteria through a clinical study in the way a PMA (Pre-market Approval) would.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria. Specifically:

• No acceptance criteria are provided.
• No study is described that details device performance against specific metrics.
• No information regarding sample size for testing or data provenance is available.
• No information about experts, adjudication methods, MRMC studies, or standalone algorithm performance is present.
• No details on training set size or ground truth establishment for a training set are found.

The document focuses on demonstrating substantial equivalence to a predicate device (Cardia Innovation AB CarbonAid™ gas diffuser K052125).

Here's what the document does state:

• Device Description: The CarbonAid® CO2 diffuser is a disposable surgical device for insufflation of CO2 into an open surgical wound during open heart surgery to create a topical 100% CO2 atmosphere, aiming to reduce air embolism risk.
• Indications for Use: The CarbonAid® CO2 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 which can result in organ damage.
• Technological Characteristics: States that "Technologically, both the new device and the predicate device are the same... Any differences between the two devices do not raise new questions of safety and effectiveness."
• Performance Data (General Statement): "Sufficient data has been gathered from testing to assess that the CarbonAid® CO2 diffuser performs as clinically intended. Biocompatibility testing has been performed to ensure that this device, its component parts and materials are biocompatible." However, specific data or a study report is not included in this summary.
• Conclusion: The device is concluded to be "substantially equivalent to the existing legally marketed device."

In summary, this 510(k) notification is a regulatory document focused on demonstrating similarity to an existing device, not a report of a study designed to prove performance against pre-defined acceptance criteria.

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The Insuflow® DewHeart™ is a Blower/Mister Gas conditioner device for use in cardiovascular surgical procedures intended to heat, humidify and filter a CO2 gas stream for introduction into the surgical cavity to improve visibility and reduce the risk of air embolism.

The Insuflow DewHeart™ device is a single use blower/mister device that attaches to the outlet port of the Insuflow controller with regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to introduction into the cardiovascular cavity. The Insuflow DewHeart™ 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 Insuflow® DewHeart™ device, through the in-line filter, continues along the tube to enter the Insuflow® DewHeart™ device cassette that contains the heating element and humidification media, through a nozzle/wand for directional. localization of a CO2 gas stream entry into the patient's surgical cavity

The provided text is a 510(k) summary for the Insuflow® DewHeart™ device, which is a blower/mister gas conditioner. It states that the device is technically the same as a previously cleared device (Insuflow®, K063546) and substantially equivalent to other predicate devices.

Here's an analysis of the requested information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. It generally states that "Extensive performance testing has been conducted to assure that the Insuflow DewHeart™ performs in accordance with its specifications and applicable standards." However, specific numerical acceptance criteria or performance results are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify any sample size for a test set. It refers to "Extensive performance testing" but does not provide details on the experimental setup or the data used. Therefore, the data provenance (country of origin, retrospective/prospective) cannot be determined from this text.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not describe any study involving human experts to establish ground truth or evaluate the device's performance. The "performance testing" mentioned appears to refer to engineering or laboratory testing against specifications, not clinical or expert-reviewed data.

4. Adjudication Method for the Test Set

As no human expert review or ground truth establishment is described, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No MRMC study is mentioned. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and intended use, rather than comparing performance with human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

The device described is a physical medical device (blower/mister gas conditioner), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The performance testing refers to the device's physical functions like heating, humidifying, and filtering.

7. The Type of Ground Truth Used

The document discusses "performance testing" against "specifications and applicable standards." This implies the ground truth for evaluating the device's functionality would be engineering specifications and established standards for heating, humidifying, and filtering CO2 gas, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

As this is a physical medical device and not an AI/machine learning algorithm, the concept of a "training set" is not relevant.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm.

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