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TruFlow™ Long-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires long-term vascular access for hemodialysis and apheresis. The TruFlow™ Short-term Dual-lumen Hemodialysis Catheter is indicated for use when therapy requires short-term vascular access for acute hemodialysis and apheresis.

TruFlow™ Long-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein.

TruFlow™ Short-term Dual-lumen Hemodialysis Catheters can be inserted percutaneously in the internal jugular, in the subclavian vein as required, or the femoral vein.

The catheters are long- and short-term dual lumen polyurethane dialysis catheters with D-shaped inner lumens and a staggered tip. Long-term catheters include a pre-attached in-growth cuff. Various product configurations will be offered, including IJ, straight and pre-curved catheters. Catheters will be offered in multi-unit packaging and with accessory components.

The provided document describes the 510(k) premarket notification for the TruFlow™ Dialysis Catheters. The assessment for this device relied on functional testing and comparison to predicate devices, rather than clinical studies or an AI-driven approach.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The document mentions "In-vitro testing" and "Biocompatibility testing" but does not quantify the number of devices or data points involved in these tests.
• Data Provenance: The studies were in-vitro (laboratory testing) and biocompatibility testing. This means the data was generated in a controlled laboratory environment and not from human subjects. The country of origin for the data is not specified other than the applicant's location (St. Paul, MN, USA). The studies were likely prospective in nature within the lab.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The ground truth for functional and biocompatibility testing is typically based on established engineering standards and laboratory protocols, not expert consensus in the way a clinical study would be.

3. Adjudication method for the test set:

• Not applicable. Adjudication methods are relevant for clinical studies involving human interpretation or outcomes, not for functional and biocompatibility laboratory testing.

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:

• No MRMC comparative effectiveness study was done. This is not an AI device. The study focused on the functional and biocompatibility performance of a physical medical device (dialysis catheter) compared to predicate devices.

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

• No standalone algorithm performance study was done. This is not an AI device.

6. The type of ground truth used:

• Functional Testing: The ground truth would be based on established engineering specifications and performance standards for dialysis catheters (e.g., flow rates, pressure resistance, structural integrity).
• Biocompatibility Testing: The ground truth would be based on international standards for biocompatibility of medical devices (e.g., ISO 10993 series), which define acceptable biological responses to materials in contact with the body.

7. The sample size for the training set:

• Not applicable. This device is a physical medical catheter, not an AI model requiring a training set.

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

• Not applicable for the same reason as above.

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