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The Medcomp Pediatric Ash Split Cath™ XL is indicated for use in attaining longterm vascular access for hemodialysis and apheresis in pediatric, adolescent, and adult patients as determined by the prescribing physician. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian and femoral vein.

The Medcomp Pediatric Ash Split Cath™ XL is a 10F polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, tapered at the distal tip, with six side holes. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed polvester cuff allows for tissue ingrowth for long term placement. A polyurethane sleeve is positioned between the hub to cuff location. The lumens are connected to the extensions via a soft pliable hub with suture wing. Red and blue luer connectors and clamps identify the arterial and venous extensions. The clamps incorporate I.D. Rings which indicate priming volume and site care information.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medcomp Pediatric Ash Split Cath™ XL:

The provided document (K020936) is a 510(k) summary for a medical device. In the context of a 510(k), the "acceptance criteria" and "device performance" are typically demonstrated through substantial equivalence to a legally marketed predicate device. This means the new device is as safe and effective as the predicate based on performance data.

Key takeaway: This submission relies on in-vitro performance data to establish substantial equivalence to predicate devices, and clinical studies were not deemed necessary. Therefore, many of the requested categories related to clinical studies, expert-established ground truth, and human reader performance are not applicable or cannot be answered from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a product line extension relying on substantial equivalence, the "acceptance criteria" are implied to be "meeting or exceeding the performance of the predicate device" in relevant in-vitro tests. The "reported device performance" is that it does meet these criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document refers to "in-vitro performance data," which implies laboratory testing of various samples of the device. The exact number of units tested for each in-vitro parameter (tensile strength, leakage, etc.) is not provided.
• Data Provenance: The data is from in-vitro testing and not from human subjects. The country of origin for the testing itself is not specified, but the submitter (Medcomp) is based in the USA (Harleysville, PA). The data is considered prospective in the sense that it was generated specifically for this 510(k) submission, even though it's laboratory data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. This device did not involve human clinical studies or the establishment of ground truth by medical experts in the way that, for example, an AI diagnostic algorithm would. The "truth" for the in-vitro tests is based on measurable physical properties and engineering standards relative to the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3. No adjudication method for expert consensus was needed as there were no clinical studies where expert opinions would need to be reconciled.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study was not done. The submission explicitly states: "Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices." Therefore, there is no information on how human readers might improve with or without AI assistance, as AI is not a component of this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a physical medical device (catheter), not a software algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Engineering/Performance Standards and Predicate Device Data: The "ground truth" for this device's performance is established by demonstrating that its in-vitro performance characteristics (tensile strength, joint strength, leakage, recirculation, flow performance, mechanical hemolysis) are substantially equivalent to those of legally marketed predicate devices. This relies on established scientific and engineering principles for material and device performance.

8. The Sample Size for the Training Set

• Not Applicable. As this is not a machine learning or AI device, there is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. See point 8.

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