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The Merit Centros and CentrosFLO Long-Term Hemodialysis Catheter for use in attaining long-tern vascular access for hemodialysis and apheresis. It may be insected 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 Centros and CentrosFLO Long-Term Hemodialysis Catheters are dual lumen, 15FR catheters available in a straight configuration with multiple lengths. The catheter comes with a stiffening stylet that can be used for over-the-wire placement. The stiffening stylet has a female Luer which is over-molded on a nylon shaft with a tapered distal tip. Distal to the female Luer is a rotating male locking collar which can be used to attach the stylet to the catheter. The catheter lumens are D-shaped and made from radiopaque Carbothane. The distal end design is a fixed length pre-formed split-tip, with (CentrosFLO) or without (Centros) side-holes. The distal venous lumen extends past the arterial lumen, and includes a quide wire slit for insertion by the optional over-the-wire placement technique. The proximal device contains a fixed polyester cuff, an integrated bifurcation, suture wing, and extension legs 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 ID tags within the occlusion clamps. The trade name and cuff-to-tip length are printed on the catheter bifurcation. The procedure kits include the necessary accessories to correctly insert the catheter.

The provided document is a 510(k) Premarket Notification for the Merit Centros/CentrosFLO Long-Term Hemodialysis Catheter. It focuses on demonstrating substantial equivalence to a predicate device through conformity to recognized performance standards and bench testing.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance data. Instead, it states that a "battery of tests was performed based on the requirements of the below recognized performance standards and draft guidance, as well as biocompatibility, sterilization, and labeling standards and guidance."

The document generally states that the device "met the predetermined acceptance criteria applicable to the safety and efficacy of the device." No specific numerical values for acceptance criteria or performance are presented.

Here's an inferred list of the performance tests conducted, with the understanding that the acceptance criteria are implicitly derived from the referenced standards and guidance documents:

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

The document does not specify the sample sizes used for any of the performance tests. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of medical device premarket notifications that rely on bench testing, it is generally assumed that these tests are conducted internally by the manufacturer (Merit Medical Systems, Inc., located in South Jordan, UT, USA) and are prospective experiments.

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

This information is not applicable and not provided in the document. The document describes bench testing against engineering standards and guidance documents, not a clinical study involving human assessment or expert consensus for "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies involving observer variability, which is not the case for the described bench tests.

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

This information is not applicable and not provided in the document. The filing describes a physical medical device (catheter) and its bench testing, not an AI or imaging diagnostic device. Therefore, no MRMC study, AI assistance, or effect size is discussed.

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

This information is not applicable and not provided in the document. As stated above, this is not an AI or algorithm-based device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the described bench tests, the "ground truth" is defined by the acceptance criteria established by the referenced international standards (e.g., ISO 10555-1, ISO 594-1/2, ISO 11135-1, ISO 10993-1, ISO 11070) and FDA guidance documents. The device's performance is compared against these predetermined, objective, and quantitative or qualitative benchmarks.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. This is not an AI or machine learning device that requires a training set.

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

This information is not applicable and not provided in the document. This is not an AI or machine learning device that requires a training set.

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