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The Uresil Gastrostomy Catheter Kit is indicated for gastroenteric feeding or drainage.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Uresil Gastrostomy Catheter Kit". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the regulatory clearance process and substantial equivalence to predicate devices, rather than performance studies.

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

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For percutaneous drainage of abscesses, nephrostomy and other fluids.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a General Purpose Drainage Catheter, stating its substantial equivalence to predicate devices and allowing it to be marketed.

It does not contain details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or the nature of test sets.
• The number or qualifications of experts used for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth used (pathology, outcomes data, etc.).
• Training set sample size or how its ground truth was established.

Therefore, I cannot fulfill your request for this specific information based on the text provided.

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The Drainage Catheters are to be used for percutaneous drainage of abscesses, nephrostomies, and other fluids.

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This is a 510(k) clearance letter for a General Purpose Drainage Catheter, which is a physical medical device. The document does not describe acceptance criteria, a study proving the device meets criteria, or any AI/algorithm performance. Therefore, I cannot provide the requested information.

Ask a specific question about this device