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Insuflow® CO2lonShield™ is a gas conditioner accessory device for use during colonoscopy procedures, including CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy procedures, and intraoperative endoscopy procedures, intended to heat, humidify and filter a CO2 gas stream for administration as a distention media.

The Insuflow® CO2lonShield™ device is a single use device that attaches to the outlet port of a regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to gas delivery during colonoscopy and intraoperative endoscopy procedures. The Insuflow® CO2lonShield™ 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® CO2lonShield™ device, through the inline filter, continues along the tube to enter the Insuflow® CO2lonShield™ device cassette that contains the heating element and humidification media, through a tube that connects to an endoscope/colonoscope or rectal probe for gas delivery into the patient's gastroenterological cavity.

The provided text is for a medical device called Insuflow® CO2lonShield™, a gas conditioner accessory device. The 510(k) summary states that "Extensive performance testing has been conducted to assure that the Insuflow CO2lonShield™ performs in accordance with its specifications and applicable standards. Details of that testing were provided in 510(k) K063546 and are summarized in Section 5."

However, the current document (K090879) does not contain the detailed acceptance criteria or the specific study results to prove the device meets these criteria. It explicitly refers to the previous 510(k) K063546 for those details. Therefore, I cannot extract the table of acceptance criteria and reported device performance from this document alone.

Based on the information available in K090879:

• 1. A table of acceptance criteria and the reported device performance: This information is not present in K090879. It refers to K063546.
• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present in K090879. It refers to K063546.
• 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): Not applicable, as this is a gas conditioning device, not an interpretative imaging device requiring expert ground truth for classification. The performance testing would likely involve technical specifications of gas temperature, humidity, and filtration.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device.
• 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 is a medical device for warming and humidifying CO2, not an AI-powered diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm. Performance would be measured against its technical specifications.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the traditional sense for this device. The "ground truth" would be the target temperature, humidity, and filtration efficiency specifications that the device is designed to meet.
• 8. The sample size for the training set: Not applicable for this type of physical device. "Training set" typically refers to machine learning algorithms.
• 9. How the ground truth for the training set was established: Not applicable for this type of physical device.

In summary, the provided document K090879 serves as a re-submission or update that references a previous 510(k) (K063546) for the detailed performance testing information. Without access to K063546, the specific performance data and acceptance criteria cannot be extracted.

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