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The Pourchez XpressO™ Catheter is designed for chronic (longterm) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown into the jugular or subclavian vein.

The Pourchez Xpresso™ is a silicone twin lumen catheter with separated tips designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.

The Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is a flexible radiopaque silicone catheter. The distal end has two tips separated over a predetermined distance. The distal arterial and venous lumens are round and are staggered to reduce recirculation. The body is oval, and the proximal end has two distinctive lumens with color-coded adapters (red for arterial and blue for venous). The catheter is available in four different tip-to-hub lengths. It is also available with and without side holes on the distal ends. The catheter has a polyester cuff located at one of four different locations from the distal end.

The provided text describes a 510(k) submission for a medical device, the Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove those criteria.

Therefore, the following information is not present in the provided text:

• A table of acceptance criteria and reported device performance specific to novel criteria (the document focuses on comparison to predicates or established ISO standards).
• Sample size used for a dedicated test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
• Information on a standalone (algorithm only) performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a primary study.
• Sample size for a training set.
• How the ground truth for the training set was established.

Based on the provided text, here is what can be extracted regarding performance and "acceptance criteria" through equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that performance was evaluated against predicate devices and ISO standards. The "acceptance criteria" were implied to be equivalent or superior performance to the predicates or exceeding minimum acceptance criteria of appropriate standards.

2. Study Description and Details:

The document describes "A series of tests were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters." This implies a bench testing approach comparing the new device against predicate devices and relevant industry standards.

• Sample size used for the test set and the data provenance: Not specified. This would typically be determined by the specific ISO standards or internal company protocols for bench testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of technical performance testing. Ground truth would be based on validated measurement methods and instrumentation.
• Adjudication method for the test set: Not applicable for this type of technical performance testing.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a technical performance assessment, not a clinical reader study.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an AI algorithm.
• The type of ground truth used: For characteristics like flow rates, lumen area, priming volumes, and material compatibility, ground truth would be established through objective physical measurements using calibrated equipment and methods defined by engineering standards or internal validation protocols. For comparison to predicate devices, the documented specifications and performance of those predicate devices serve as the reference.
• The sample size for the training set: Not applicable as this is not an AI/machine learning study.
• How the ground truth for the training set was established: Not applicable.

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