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The Kendal! Dual Lumen Catheters are intended for use as short-term vascular access for hemodialysis. The catheters can be inserted in the femoral, subclavian or jugular vein as required.

The Kendall Dual Lumen Catheters are single use, sterile devices. The single radiopaque cannula catheters have two distinct lumina which provide simultaneous "arterial" outflow and "venous" return. The catheters have two extension tubes, sach with a color-coded in-line clamp (red for arterial outflow, blue for venous return) and luer lock adapter. The catheters are sold in 8.5, 10.0 and 11.0 Fr sizes.

This document only provides information about a 510(k) submission for a medical device (Kendall CURITY Dual Lumen Subclavian Catheters) and does not describe acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity for image analysis).

The provided text focuses on demonstrating substantial equivalence to a predicate device, which is a different type of regulatory submission than one requiring a clinical performance study with defined acceptance criteria for diagnostic output.

Here's a breakdown based on the information provided, highlighting why most of your requested points cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Not applicable / Not provided. The document describes non-clinical performance (flow rate, hemolysis, recirculation, biocompatibility) and notes these were "similar" to the predicate device. It does not define specific quantitative acceptance criteria for these tests nor does it provide a table of performance against such criteria. Crucially, there are no diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because this is not a diagnostic device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No diagnostic test set was used. The non-clinical comparative testing would have involved lab-based samples for flow rate, hemolysis, and recirculation, but specific sample sizes, provenance, or study types (retrospective/prospective) are not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No ground truth was established for a diagnostic test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No diagnostic test set was used.

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

• No. This device is a vascular access catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study is not relevant and was not performed.

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

• Not applicable. This is a medical device (catheter), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. No ground truth for diagnostic purposes was established. The "truth" for the non-clinical tests would be the measured physical and functional properties of the catheters.

8. The sample size for the training set

• Not applicable. This is a medical device, not an AI model, so there is no training set in the context you're asking about.

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

• Not applicable. As above, no training set for an AI model.

Summary of Relevant Information from the Provided Text:

• Device Type: Hemodialysis System and Accessories, specifically Kendall CURITY Dual Lumen Subclavian Catheters.
• Intended Use: Short-term vascular access for hemodialysis.
• Regulatory Pathway: 510(k) submission, demonstrating substantial equivalence to a predicate device (Neostar Dual Lumen Catheters, K941851).
• Performance Data Provided:
  • Non-Clinical Tests: Comparative testing with the predicate device.
    • Criteria included: flow rate, hemolysis, recirculation studies.
    • Results: Found "similar physical and functional properties" to the predicate.
    • Biocompatibility testing was also performed and demonstrated no bioactive components.
  • Clinical Tests: "No clinical testing was performed."
• Conclusion: The device is similar in design, physical, and functional attributes to the predicate device.

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