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The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.

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I apologize, but the provided text from the FDA 510(k) clearance letters and "Indications for Use" document does not contain the specific information required to describe the acceptance criteria and the study proving the device meets those criteria.

The documents primarily focus on:

• Administrative corrections to trade names (Document 0).
• Substantial equivalence determination for the AquaShield System (Document 1).
• General regulatory information and compliance requirements for medical devices (Document 1 & 2).
• Indications for Use of the AquaShield System (Document 3), which states its purpose is to supply sterile water to endoscope procedures and its compatibility with US commercially available water bottles.

There is no mention of:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test sets, data provenance, or details on training sets.
• Number or qualifications of experts, establishment of ground truth, or adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report.

Ask a specific question about this device

The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with U.S. commercially available water bottles.

Not Found

I am sorry, but the provided text only contains an FDA clearance letter for a medical device called "AquaShield System CO2." It specifies the device's intended use and regulatory classification but does not include information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device