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The 15.5Fr. Decathlon 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.

The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter is a product line extension of Spire Biomedical, Inc.'s Pourchez XpressO™ flexible radiopaque silicone catheters and supplements our Pourchez XpressO catheter line by offering a polyurethane catheter with similar tip-to-hub length catheters of 24cm, 28cm, 32cm, 36cm & 40cm. The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter's split tip design (with the exception of the polyurethane catheter body, clear urethane tubing, urethane hub and cross-sectional profile) are identical to our silicone Pourchez XpressO™ catheters listed within our 510(K) Premarket Notification Submission (K013160). The round outer profile with semi-circular cross-sectional lumens is similar to the MedComp Ash Split Cath™. The polyurethane catheter body material is identical to that used in the Kendall Healthcare Maxid™ catheter, as verified by an IR Scan analysis (Appendix (Appendix (G). Optional use of polyvinyl chloride luer adapters has also been qualified.

The provided document (K032061) describes a 510(k) premarket notification for a medical device, specifically a 15.5Fr Polyurethane "Decathlon" Twin Lumen Chronic Hemodialysis Catheter. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study that establishes acceptance criteria and then proves the device meets those criteria in the context of an AI/human performance study.

Therefore, much of the requested information regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment cannot be found in this document because the document describes a traditional medical device (a catheter) and not an AI/ML-driven device.

However, I can extract the information related to the device's performance based on the provided text.

Here's an attempt to answer the questions based only on the provided text, noting where information is unavailable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by comparison to predicate devices and/or conformance to established ISO standards for hemodialysis catheters. The document states the device met these criteria. Specific numerical values for criteria are not detailed in this summary.

2. Sample size used for the test set and the data provenance

This document describes a physical medical device (catheter), not an AI algorithm. Therefore, the concept of a "test set" in the context of AI performance data (e.g., images for classification, clinical data for prediction) does not apply here. The document describes tests performed on the physical catheter rather than a test set of data.

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

Not applicable. This is for a physical medical device, not an AI algorithm requiring expert ground truth for a test set.

4. Adjudication method for the test set

Not applicable. This is for a physical medical device, not an AI algorithm with a test set requiring 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. This document pertains to a physical medical device. It does not involve AI or human readers.

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

Not applicable. This document pertains to a physical medical device, not an AI algorithm.

7. The type of ground truth used

For the performance data described, the "ground truth" is established through:

• Comparison to predicate devices: Performance characteristics (flow rates, priming volumes) were deemed acceptable if they were "similar" to the legally marketed predicate devices.
• Conformance to established ISO standards: Mechanical and physical tests were evaluated against relevant ISO standards for hemodialysis catheters.
• Analytical verification: Material composition was verified through an "IR Scan analysis."

8. The sample size for the training set

Not applicable. This document is for a physical medical device, not an AI algorithm with a training set.

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

Not applicable. This document is for a physical medical device, not an AI algorithm.

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