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The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep™ Antegrade Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow® NextStep™ Antegrade catheter is intended for use in adult patients.

The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is a 15 Fr, 2 lumen, one piece Carbothane catheter with a preloaded stylet and step tip designed for antegrade placement. The catheter is available in multiple lengths. The procedure kit includes the necessary accessories to correctly insert the catheter.

The provided 510(k) summary for the Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter (K102238) does not describe a study that uses AI/algorithm performance. Instead, it focuses on demonstrating the substantial equivalence of a medical device (a catheter) to a predicate device through traditional engineering and biological performance testing.

Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in this context.

Here's a breakdown of the information that is available based on your request, adapted for a medical device rather than an AI/algorithm:

Acceptance Criteria and Device Performance for Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter (K102238)

This submission describes a medical device, a chronic hemodialysis catheter, and its performance is assessed through laboratory testing to demonstrate substantial equivalence to a predicate device, not through an AI/algorithm performance study.

1. Table of Acceptance Criteria and Reported Device Performance

Conclusion from Submission: "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices. Based on the indications for use, design, safety and performance testing, the Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheters met the requirements that are considered adequate for its intended use and is substantially equivalent to the predicate devices."

The following points are not applicable (N/A) as the submission describes a physical medical device and not an AI/algorithm:

2. Sample size used for the test set and the data provenance: N/A (This was a physical device performance study, not a data-driven test set.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth is not relevant for physical device testing this context; performance is measured against physical standards/benchmarks.)
4. Adjudication method for the test set: N/A (Not applicable for physical device testing.)
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: N/A (This is not an AI-assisted device.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is not an algorithm.)
7. The type of ground truth used: N/A (For physical devices, performance is measured against engineering specifications, industry standards, and predicate device performance, not "ground truth" derived from expert consensus or pathology in the sense of an AI model.)
8. The sample size for the training set: N/A (This is not an AI/algorithm that requires a training set.)
9. How the ground truth for the training set was established: N/A (Not applicable.)

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