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The CATHTONG III Tapered PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 5.0 mL/sec for the 4F single lumen catheters and the 5F dual lumen catheters. The maximum pressure of power injection with the CATHTONG III Tapered PICC Catheter may not exceed 325 psi. The CATHTONG III Tapered PICC Catheter is indicated for adult patients.

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The provided text is a 510(k) summary from the FDA for a medical device called the CATHTONG III Tapered PICC Catheter. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, this document does not contain information regarding a study that proves the device meets acceptance criteria, nor does it provide details on algorithm performance, expert consensus, ground truth establishment, or sample sizes related to AI/algorithm performance. These types of details are typically found in the clinical or non-clinical performance sections of a 510(k) submission, which are often redacted or not fully included in the publicly available summary letter.

Therefore, I cannot fulfill your request for information on acceptance criteria and study details based on the provided text. The document primarily focuses on the regulatory clearance process and the intended use of the catheter.

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