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The HemoSplit™ XK long-term hemodialysis catheter is indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion.

HemoSplit XK Long-Term Dialysis Catheters are dual lumen catheters available in straight configurations with multiple insertion lengths. The HemoSplit XK has a dual lumen, double-D crosssectional design with a venous lumen tip opening molded to facilitate over-the-guide wire placement. The arterial and venous lumens are separated a maximum of 8cm proximal to the distal tip of the venous lumen, and are able to float freely in the blood stream. The molded bifurcation has an integral suture wing that is suitable for use with StatLock® securement devices. Individual arterial and venous lumen extension leg have an atraumatic occlusion clamp, which closes the access to the lumen. The clamps have integral tags with the priming volumes of the individual lumen printed on them. Red and blue color-coded luer connectors identify the arterial and venous lumens, respectively.

The provided text describes a Special 510(k) submission for a medical device, the HemoSplit™ XK Dual Lumen Catheter. This type of submission is for modifications to a previously cleared device. Therefore, the "study" conducted for this submission is less about a de novo clinical trial and more about bench testing to demonstrate substantial equivalence to the predicate device.

Here's an analysis of the provided information against your requested criteria:

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

Study Proving Device Meets Acceptance Criteria:

The study conducted was a series of non-clinical bench tests performed according to recognized standards and FDA guidance. The submission states: "All test results confirm the modified device to be substantially equivalent to the predicate device." and "The HemoSplit XK Long-Term Dialysis Catheter met all the pre-determined performance criteria of the tests performed..."

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

• Sample Size: The document does not specify the exact sample size for the bench tests. However, for non-clinical testing of this nature, sample sizes are typically determined by relevant ISO standards or in-house protocols, often involving multiples of tested units (e.g., 5, 10, or 30 units per test).
• Data Provenance: The tests were conducted internally ("conformance to in-house protocols") by Bard Access Systems, Inc. in the USA. The data is prospective in the sense that the new device was specifically manufactured and tested for this submission.

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)

This is a non-clinical/bench testing submission, not a study evaluating human interpretation or clinical outcomes. Therefore:

• Number of Experts: Not applicable. Ground truth for bench tests is based on objective measurements against established technical specifications and standards, not expert consensus on medical imaging or diagnoses.
• Qualifications of Experts: Not applicable. The "experts" involved would be engineers, technicians, and quality assurance personnel with expertise in medical device testing and regulatory compliance, ensuring the tests were performed correctly and the results interpreted against the standards.

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

• Adjudication Method: Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies for resolving discrepancies in expert interpretations (e.g., of medical images). For non-clinical bench testing, the results are typically quantitative and objectively measured against pre-defined pass/fail criteria from recognized standards. Any discrepancies would relate to test methodology or equipment calibration, not subjective medical interpretation.

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 submission is for a physical medical device (catheter) modification, not an AI-powered diagnostic tool.
• Effect Size of AI: Not applicable, as no AI component is involved.

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

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

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

• Type of Ground Truth: The "ground truth" for this submission are the recognized standards and internal protocols (e.g., ISO 10555-1/-3, ISO 10993-1, ISO 11135, FDA Guidance 3/16/95). The device's performance was measured against the objective technical requirements and specifications outlined in these documents and compared to the established performance of the predicate device.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."

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

• Training Set Ground Truth Establishment: Not applicable, as there is no training set for this type of device submission.

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