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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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The CATHTONGTM II PICC Catheter is intended for short or long-term peripheral access to the central yenous 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 3.0 mL/sec for 3F and 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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The provided text is an FDA 510(k) clearance letter for the CATHTONG™ II PICC Catheter. It does not contain information about acceptance criteria, device performance studies, or the methodologies for establishing ground truth, sample sizes, or expert qualifications as typically found in a clinical study report or a detailed summary of safety and effectiveness.

The document primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" for the catheter and provides specific maximum flow rates and injection limits for different catheter sizes (3F and 4F single lumen) and a maximum pressure of power injection (325 psi). These specifications look like they are part of the acceptance criteria that need to be met by the device.

To answer your request, a study proving the device meets these acceptance criteria would typically involve:

1. Bench testing: To verify the flow rates and pressure limits under various conditions.
2. Biocompatibility testing: To ensure the materials are safe for human contact.
3. Sterilization validation: To confirm the sterility assurance level.
4. Performance testing: To demonstrate the catheter's ability to maintain patency and integrity under simulated use.
5. Clinical data (if required for substantial equivalence): This could involve a review of existing data of the predicate devices or, in some cases, limited clinical data if the technological characteristics are significantly different.

Since the provided text is only the FDA's clearance letter, these details are not available within the given document. Therefore, I am unable to fill out the table and provide the requested information about the study design, sample sizes, ground truth establishment, expert qualifications, or MRMC data.

The document only provides the following directly relevant to acceptance criteria, which appear to be performance specifications:

All other requested information is not present in the provided text.

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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 2.5 mL/sec for 4F and 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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This document is a 510(k) premarket notification decision letter for the Cathtong™ II PICC Catheter, not a study report. Therefore, it does not contain the detailed information required to fill out all the fields in your request about acceptance criteria and the study proving the device meets them.

The 510(k) summary (which is typically a separate document from this decision letter) for K170486 would provide information on how substantial equivalence was demonstrated, often including performance data. However, based only on the provided text, I can infer some performance-related criteria:

Based on the "Indications for Use" section, the following performance specifications are provided, which could be considered acceptance criteria:

The document does not provide the following information:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described in this letter.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not described in this letter.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not described in this letter.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a medical catheter, not an AI or imaging diagnostic device that would involve human readers.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for this type of medical device.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not described in this letter, as specific studies are not detailed.
7. The sample size for the training set: Not applicable; this is a physical medical device, not an AI algorithm requiring a training set in that context. Any "training" would refer to manufacturing process validation.
8. How the ground truth for the training set was established: Not applicable.

To obtain the detailed study information you're asking for, you would typically need to refer to the full 510(k) submission or a summary of safety and effectiveness, which are usually publicly available on the FDA website for successful applications. This particular document is the FDA's decision letter confirming substantial equivalence.

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