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The CATHTONG™ II 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 4F single lumen catheters. The maximum pressure of power injection with the CATHTONG™ II PICC Catheter may not exceed 325 psi. The CATHTONG™ II PICC Catheter is indicated for adult patients.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, training set sizes, or how training set ground truth was established for a medical device.

The document is an FDA 510(k) clearance letter for the CATHTONG™ II PICC Catheter. It states that the device is substantially equivalent to legally marketed predicate devices and outlines its indications for use, including maximum flow rate and injection limit setting. However, it does not provide the detailed study information you're requesting.

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The CATHTONG™ II 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 contrastration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 5.0 mL/sec for 5F dual lumen catheters. The maximum pressure of power injection with the CATHTONG™ II PICC Catheter may not exceed 325 psi. The CATHTONG™ II PICC Catheter is indicated for adult patients.

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The provided document does not contain information about the acceptance criteria and study proving device performance in the context of an AI/ML powered device.

The document is an FDA 510(k) clearance letter for a medical device called the "CATHTONG™ II PICC Catheter." This is a physical, interventional medical device, not an AI/ML software device.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance (for AI/ML metrics like sensitivity, specificity, AUC).
• Sample size for a test set or training set.
• Data provenance for AI/ML models.
• Number of experts used to establish ground truth for AI/ML.
• Adjudication methods for AI/ML ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone performance of an algorithm.
• Type of ground truth used for AI/ML training/testing.

The information in the document pertains to the regulatory clearance of a physical medical catheter, including its indications for use, maximum flow rates, and injection limits. These are performance specifications for a hardware device, not evaluation metrics for an AI/ML algorithm.

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