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The Arrow NextStep Antegrade Chronic Hemodialysis Catheter is intended for use in adult patients. The Arrow NextStep Antegrade 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 one piece, two lumen, 15 Fr., step tipped catheter designed for antegrade placement. The catheter is available in multiple lengths.

This is a 510(k) summary for a medical device modification, not a study evaluating AI performance or diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria for an AI/CADe device, sample sizes for test sets, expert involvement, and MRMC studies is not applicable.

The document describes a device modification for the Arrow® NextStep® Antegrade Chronic Hemodialysis Catheter. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical tests.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria was a non-clinical testing study focused on the physical characteristics of the catheter.

2. Sample size used for the test set and the data provenance:

• Sample size: Not specified. The document states "Kink and column strength tests were performed," but does not provide details on the number of catheters tested.
• Data provenance: Not applicable in the context of clinical data. This refers to physical product testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of experts: Not applicable. The ground truth for physical performance tests (kink, column strength) is based on engineering specifications and direct measurement, not expert opinion.

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

• Adjudication method: Not applicable. This concept is relevant for reconciling conflicting expert opinions, which did not occur here.

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:

• MRMC study: No, an MRMC comparative effectiveness study was not done. This device is a physical medical catheter, not an AI or CADe system.

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

• Standalone performance: No, a standalone performance study was not done. This is not an algorithm.

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

• Type of ground truth: Engineering specifications and physical measurements for kink resistance and column strength.

8. The sample size for the training set:

• Sample size for training set: Not applicable. As this is not an AI/ML device, there is no training set in the conventional sense. The "training" for the device's design would be iterative engineering and material science development.

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

• How ground truth for training set was established: Not applicable. There is no training set. The "ground truth" for the device's design and materials would be based on established engineering principles, material properties, and previous iterations of similar devices.

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