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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.

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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 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

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.

Not Found

The provided document is an FDA 510(k) clearance letter for the "AquaShield System CO2- Fujifilm." This letter indicates that the device has been cleared for marketing based on substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria, a specific study proving those criteria, or details regarding performance metrics for a diagnostic or AI-driven device.

The AquaShield System CO2- Fujifilm is described as a system "intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures." This suggests it is an accessory for endoscopy procedures, likely for irrigation or insufflation, rather than a diagnostic device with performance metrics typically associated with AI or imaging analyses.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are relevant for AI/ML-driven diagnostic devices, but not for the type of device described in this 510(k) clearance.

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