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The 55cm Pourchez RetrO Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown. Catheters longer than 40cm can be used for femoral insertion.

55cm Pourchez RetrO™ Silicone Twin Lumen Chronic Device Hemodialysis Catheter with Separated Tips. The 55cm Pourchez RetrO catheter uses the exact same materials of construction.

The provided text is a 510(k) summary for a medical device, the "55cm Pourchez RetrO Kit" or "Pourchez RetrO Twin Lumen Chronic Hemodialysis Catheter with Separated Tips." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a study involving human-in-the-loop or standalone AI performance.

Therefore, many of the requested details about acceptance criteria, study design, and AI performance metrics are not applicable or cannot be extracted from this type of regulatory submission. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through engineering and bench testing, rather than extensive clinical trials with human readers or AI.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

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

   This document does not specify quantitative acceptance criteria. Instead, it asserts that "A series of mechanical and physical tests, including tensile and flow, were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters." The "reported device performance" is essentially that these tests did demonstrate substantial equivalence or conformance.

   Acceptance Criteria	Reported Device Performance
   Substantial equivalence to predicate devices (K022000) for mechanical and physical properties.	Demonstrated via mechanical and physical tests (tensile and flow).
   Conformance to established ISO standards for hemodialysis catheters.	Demonstrated via mechanical and physical tests (tensile and flow).

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

   Not applicable. The "tests" mentioned are mechanical and physical bench tests, not clinical studies with patients or data sets in the typical sense for AI/human performance. No sample size for a test set (e.g., patient data) is provided, nor is data provenance.

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)

   Not applicable. Ground truth for device performance in this context would be physical measurements from the aforementioned mechanical and physical tests, not expert consensus on medical images or diagnoses.

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

   Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.

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

   Not applicable. No MRMC study was performed, as this device (a catheter) is not an AI-assisted diagnostic tool.

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

   Not applicable. This is a physical medical device, not a standalone algorithm.

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

   The "ground truth" for the performance claims appears to be derived from objective measurements from mechanical and physical bench tests, and conformance to ISO standards for hemodialysis catheters.

8. The sample size for the training set

   Not applicable. This is a physical medical device; there's no "training set" in the context of an AI algorithm.

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

   Not applicable, as there is no training set mentioned in the context of AI. For the manufacturing and quality control of the physical device, ground truth would be established through engineering specifications and industry standards.

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