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The Ash Advance™ Hemodialysis Catheter and Procedure Kit is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. This catheter is indicated for > 30 days long-term placement.

The Ash Advance™ Hemodialysis Catheter and Procedure Kit is a dual lumen, 15FR catheter available in multiple lengths. The catheter lumens are D-shaped and made from radiopaque Carbothane. The distal end design is a fixed length split-tip, without rom radiopaque Caro venous lumen extends past the arterial lumen, and includes a guidewire slit for insertion by the optional guidewire placement technique. The proximal device contains a fixed polyester cuff, an integrated hub, suture wing, and extension set with color coded occlusion clamps and luer connectors (red and blue for the arterial and venous lumens respectively). The lumen priming volumes are printed on the clamps. The procedure kit includes the necessary accessories to correctly insert the catheter.

This document describes the Ash Advance™ Hemodialysis Catheter and Procedure Kit, a medical device for long-term vascular access in hemodialysis and apheresis. The 510(k) summary (K070572) focuses on non-clinical testing for substantial equivalence to predicate devices, rather than a clinical study evaluating specific performance metrics against pre-defined acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and study design for performance evaluation of AI/algorithm-only performance is not available in these documents.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
The document does not explicitly state numerical acceptance criteria for these tests. Instead, it broadly indicates that "The safety and performance... have been substantiated through extensive non-clinical testing, including [listed tests]." The conclusion is that the device "can reliably perform" and raises "no new questions of safety or effectiveness," implying that the results met internal or industry standards for these non-clinical tests.

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

This information is not provided in the document. The testing described is "non-clinical," which typically refers to bench testing and in-vitro studies, not human clinical trials. Thus, there is no "data provenance" in terms of country of origin of data or retrospective/prospective study design as would apply to clinical performance.

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

This information is not applicable/provided. The evaluation was based on non-clinical engineering and material tests, not on expert assessment of clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As the testing was non-clinical, there was no need for expert adjudication of results in the way it would be applied to clinical outcomes or image interpretations.

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

No. An MRMC study is a clinical study involving human readers evaluating cases, often with and without AI assistance. This document describes non-clinical testing of a physical medical device (catheter) and does not involve AI or human image interpretation.

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

No. This device is a physical medical catheter, not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be defined by engineering specifications, industry standards, and regulatory requirements for medical devices of this type. For example, for tensile strength, the ground truth would be a defined minimum tensile strength value that the catheter must withstand. For leakage, it would be a maximum allowable leakage rate.

8. The Sample Size for the Training Set

This information is not applicable/provided. The document describes non-clinical testing of a physical device, not an AI or machine learning model that would require a training set.

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

This information is not applicable/provided. As above, there is no training set for a physical medical catheter.

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