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The Trio-CT® Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.
• The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.

The Trio-CT® Triple Lumen Catheter is a short-term (less than 30 days) dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (purple) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, power injection of contrast media, central venous pressure monitoring, blood draws and infusion of medications. The catheter is available with straight or curved extensions in a variety of lengths to accommodate physician preference and clinical needs. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.

The provided text describes the submission of a medical device, the "Trio-CT® Triple Lumen Catheter w/ Curved Extensions," for FDA 510(k) clearance, asserting its substantial equivalence to a predicate device, the "Trio-CT™ Triple Lumen Catheter." The document focuses on regulatory compliance and does not detail a study proving the device meets specific acceptance criteria in the context of an AI/human-in-the-loop performance study.

Therefore, many of the requested elements for an AI evaluation study, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity, AUC), sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI training sets, are not applicable to this document. This document pertains to the regulatory clearance of a physical medical device, not an AI software component.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its substantial equivalence.

Here's the relevant information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the format typically used for performance studies (e.g., sensitivity, specificity thresholds). Instead, it compares the technical specifications and performance characteristics of the subject device to its predicate to demonstrate substantial equivalence. The "acceptance criteria" are implied to be that the subject device's performance is comparable to or better than the predicate device across various technical and performance specifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not applicable. The document describes non-clinical testing for a physical medical device, not a test set for an AI algorithm. The performance testing was "Design validation performance testing... leveraged from the predicate device manufactured by Medical Components, Inc." and "Design verification performance testing was completed to confirm performance criteria of the subject device." No specific sample sizes for these tests are mentioned in the provided text, nor is data provenance in the context of patient data described.

3. 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):

This information is not applicable as this document does not concern an AI/algorithm where human expert ground truth would be established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable.

5. 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:

This information is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance comes from adherence to established technical specifications and performance characteristics, and the results of various non-clinical tests. These include:

• Biocompatibility Evaluation: This involved specific tests like ISO Muscle Implantation, USP Rabbit Pyrogen, ASTM Hemolysis, SC5b-9 Complement Activation Assay, ISO Guinea Pig Maximization Sensitization, ISO Intracutaneous, Cytotoxicity Study, ISO Acute Systemic Toxicity, ISO Systemic Toxicity in Rat, Bacterial Reverse Mutation, Genotoxicity: Mouse Lymphoma Assay, Infrared Spectroscopy, Mechanical Hemolysis Testing, and In Vivo GLP 30 Day Thromboresistance Study. These tests provide "ground truth" regarding the material's safety and biological interactions.
• Performance Testing: This refers to design verification tests to confirm the device meets its specified technical characteristics (e.g., Catheter French Size, Inner Diameters, Priming Volume, Power Injection Pressure, Flow Rate vs. Pressure). The "ground truth" here is the direct measurement of these physical properties.

8. The sample size for the training set:

This information is not applicable. The document focuses on regulatory clearance of a physical medical device, not an AI algorithm.

9. How the ground truth for the training set was established:

This information is not applicable.

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