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The Medcomp Ash Split-Cath is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site is the subclavian vein as required.

The Medcomp Ash Split-Cath is a 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 polyester cuff allows for tissue ingrowth for long term placement. 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.

Acceptance Criteria and Device Performance for Medcomp Ash Split-Cath Hemodialysis Catheter

This document describes the acceptance criteria and performance data for the Medcomp Ash Split-Cath Hemodialysis Catheter, as presented in the K013162 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for each test. Instead, it indicates that the in-vitro performance data was "sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device." This implies that the observed performance in these tests met the established engineering specifications and benchmarks set by the predicate device (K972207 Medcomp Ash Split-Cath).

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified. The document states "In Vitro performance data," which typically involves testing a defined number of units, but the exact sample size for each test is not provided.
• Data Provenance: The data is from in-vitro testing (bench testing) conducted by Medcomp®. No information is provided regarding the country of origin or whether it was retrospective or prospective, as it's not clinical data.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. This submission focuses on in-vitro performance data for a medical device and does not involve human expert interpretation of data or images for ground truth establishment. Clinical data was explicitly "not deemed necessary."

4. Adjudication Method for the Test Set

• Not applicable. As the study involves in-vitro bench testing, there is no adjudication method in the context described (e.g., for expert disagreement on clinical cases). The results of the physical tests are objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The submission states, "Clinical data was not deemed necessary since in-vitro testing was sufficient To demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device." Therefore, there is no information on human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. This submission concerns a physical medical device (catheter), not an AI algorithm.

7. Type of Ground Truth Used

• Engineering Specifications / Predicate Device Performance: The "ground truth" for the in-vitro tests is implicitly established by the engineering specifications for the device and, more importantly, by the performance of the legally marketed predicate device (K972207 Medcomp Ash Split-Cath) that the modified device is compared against for substantial equivalence.

8. Sample Size for the Training Set

• Not applicable. This submission does not involve machine learning or AI, and therefore, there is no "training set."

9. How Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set, this question is not relevant.

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