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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 24cm tip to hub length Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is a product line extension of Spire Biomedical, Inc.'s the Pourchez XpressO™ flexible radiopaque silicone catheters. The 24cm catheter supplements the other four tip to hub length catheters (28cm, 32cm, 36cm and 40cm) catheters. The 24cm is also available with and without side holes on the distal ends.

The provided text describes a 510(k) summary for a medical device, the 24cm Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data from a standalone study or a multi-reader, multi-case (MRMC) comparative effectiveness study.

Therefore, many of the requested items (acceptance criteria, specific reported performance metrics, sample sizes, ground truth details, expert qualifications, adjudication methods, and MRMC study details) are not explicitly present in the provided document.

However, based on the furnished text, here's what can be extracted:

Acceptance Criteria and Device Performance

The document states that the 24cm Pourchez XpressO™ Catheter demonstrated equivalent or superior performance to the predicate devices or exceeded the minimum acceptance criteria established by the appropriate standard.

Study Details

Given the nature of a 510(k) summary for a product line extension, the "study" referred to is a series of tests to demonstrate substantial equivalence, rather than a clinical trial with human subjects.

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

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified. The tests were performed to compare against predicate devices or ISO standards, implying laboratory-based testing rather than clinical data from a specific country. This is likely retrospective in the sense that the predicate device data is pre-existing, and the new device's performance is measured against it.

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

   • Not applicable as this is a device performance test against predicate devices and ISO standards, not a diagnostic or AI-assisted study requiring human expert ground truth.

3. Adjudication method for the test set:

   • Not applicable for a device performance test.

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. This is a medical device (catheter) and not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging product that would typically involve human readers.

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

   • Yes, device performance "tests were performed" on the catheter itself, in a standalone manner, to demonstrate its characteristics. However, this is not a software algorithm, but a physical medical device.

6. The type of ground truth used:

   • Predicate Device Performance Data: Performance characteristics of legally marketed predicate devices (Medical Components, Inc. Ash Split Cath™ and MedComp Pourchez XpressO™) served as a benchmark.
   • Established ISO Standards for Hemodialysis Catheters: Compliance with these standards formed another part of the "ground truth" or acceptance criteria.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning product requiring a training set.

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

   • Not applicable.

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