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The Power-Trialysis™ Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 ml/sec for power injection of contrast media.

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Here's an analysis of the provided text regarding the Power-Trialysis™ Short-Term Dialysis Catheter, extracting information about acceptance criteria and supporting studies:

This document is a 510(k) summary for a medical device seeking premarket notification clearance. For such submissions, the primary "study" is often a comparison to a predicate device, focusing on substantial equivalence in design, materials, manufacturing, and performance characteristics rather than a clinical trial with specific acceptance criteria in the same way a new drug would have.

Based on the provided text, the device is cleared based on substantial equivalence to previously marketed predicate devices, not on meeting specific, quantifiable acceptance criteria established by a clinical study. The "performance testing" mentioned is likely bench testing to demonstrate that the new device performs similarly to the predicate, especially for its new features (like power injection).

Here's the breakdown based on your requested information:

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

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

The document does not mention a specific sample size or test set in the context of a clinical study. The clearance is based on the concept of substantial equivalence, which primarily relies on comparison to existing predicate devices through engineering, material, and performance testing (benchtop, rarely clinical for 510(k)s unless there are significant changes).

Therefore, details like data provenance or retrospective/prospective studies are not provided because a clinical test set in the traditional sense was not performed for this 510(k) submission. "Performance testing" is mentioned, which refers to engineering and bench testing, not human clinical trials.

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)

Not applicable. This device clearance is based on substantial equivalence to predicate devices, supported by engineering and laboratory testing. There is no mention of a human-read test set or expert consensus to establish ground truth for clinical performance.

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

Not applicable. As there is no clinical test set involving human judgment described, there is no adjudication method.

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 device is a physical medical catheter, not an AI or imaging diagnostic device. Therefore, a MRMC study or AI assistance is irrelevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The ground truth in this context is the established safety and effectiveness of the predicate devices. The new device's equivalence in design, materials, intended use, and performance characteristics (demonstrated through bench testing) serves as the basis for its perceived "ground truth" of substantial equivalence. There is no mention of clinical outcomes data, pathology, or expert consensus specific to the new device's performance that would serve as ground truth in a clinical study.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. No training set is involved.

Summary of 510(k) Clearance Approach:

The clearance for the Power-Trialysis™ Short-Term Dialysis Catheter is achieved through the 510(k) pathway by demonstrating substantial equivalence to existing predicate devices. This involves showing that the new device has:

• The same intended use.
• Similar technological characteristics (design, materials, principles of operation).
• No new questions of safety or efficacy.

Performance testing typically refers to non-clinical (benchtop) tests (e.g., flow rates, material compatibility, strength, pressure resistance for power injection) to ensure the device performs as expected and is comparable to the predicate for critical parameters. The document explicitly states: "Based on the indications for use, technological characteristics, and safety and performance testing, the subject Power-Trialysis™ catheters met the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates."

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