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The Centros™ Chronic Hemodialysis Catheter Set is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted 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® Chronic Hemodialysis Catheter Set is a dual lumen, 15FR catheter available in multiple lengths, in straight and pre-curved configurations. The catheter lumens are D-shaped and made from radiopaque Carbothane. The distal end design is a fixed length split-tip, without side-holes. The distal venous lumen extends past the arterial lumen, and includes a guidewire slit for insertion by the optional guidewire placement technique. The proximal device contains a fixed polyester cuff, an integrated hub, suture wing, and extension set 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 the clamps. The procedure kit includes the necessary accessories to correctly insert the catheter.

The provided text is a 510(k) summary for a medical device (Centros® Chronic Hemodialysis Catheter Set), not a study report or clinical trial. Therefore, it does not contain the detailed information typically found in an acceptance criteria study report for an AI/ML powered medical device.

Based on the provided text, here's what can be extracted and what cannot:

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

The document describes non-clinical testing to substantiate safety and performance. It does not provide a table of explicit acceptance criteria with specific numerical targets and corresponding reported performance values for those criteria. It states:

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

• Sample size for test set: Not applicable. The testing was non-clinical (mechanical/material tests), not on a test set of data.
• Data provenance: Not applicable. The testing described is on the physical device and its components, not on data.

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

Not applicable. There is no mention of human experts establishing ground truth as this is a physical device evaluation, not an AI/ML diagnostic or prognostic tool.

4. Adjudication method for the test set:

Not applicable, as there is no test set in the context of an AI/ML device.

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:

Not applicable. This is a conventional medical device (catheter), not an AI/ML powered device, so no MRMC study would be performed for it.

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

Not applicable. This is a conventional medical device.

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

Not applicable. Ground truth, in the context of AI/ML, refers to validated labels for a dataset. The testing conducted for this device is focused on physical and mechanical properties against engineering standards.

8. The sample size for the training set:

Not applicable. This is a conventional medical device. It does not involve AI/ML requiring a training set.

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

Not applicable. As there is no AI/ML component, there's no training set or ground truth in that context.

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