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To replace: Cracked or broken female luer lock connectors or repair damaged extension leg where there is a minimum of 4.5 cm of viable extension tubing on the following Vas-Cath catheters: Soft-Cell® Long-Term Dual Lumen Catheter, Opti-Flow® Long-Term Dual Lumen Catheter, Slim-Cath™ Short-Term Dual Lumen Catheter, Vaccess® Short-Term Single Lumen Catheter, Flexxicon® Short-Term Dual Lumen Catheter, Niagara™ Short-Term Dual Lumen Catheter, Flexxicon® II Short-Term Dual Lumen Catheter, HemoGlide™ Long-Term Dual Lumen Catheter.

The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.

The provided document is a 510(k) summary for a Catheter Repair Kit with Replacement Connector. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical performance studies with acceptance criteria.

Therefore, this document does not contain information regarding:

• Acceptance criteria and reported device performance in the context of a clinical study.
• Sample sizes for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number/qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, expert consensus).
• How ground truth for a training set was established.

Instead, the document focuses on demonstrating substantial equivalence based on technological characteristics and intended use.

Here's a breakdown of what the document does state in relation to the prompt:

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

• Not Applicable. This document does not describe performance in terms of clinical acceptance criteria for a device. It asserts that the new device has "exactly the same" technological characteristics as the predicate device (K011015) and that the intended use is "identical" or "the same." The only difference noted is the addition of one catheter trade name (HemoGlide™) to the list of repairable catheters and a minor labeling consistency change (temporary to short-term).
• The "performance" implied is that it will perform identically to the predicate device because it is technologically the same.

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

• Not Applicable. No test set or clinical data is presented or referenced for device performance. The 510(k) relies on comparison to a predicate.

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. No "ground truth" establishment by experts for a test set is described.

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

• Not Applicable. No test set or adjudication is mentioned.

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 not an AI (Artificial Intelligence) device, and no MRMC study or AI assistance is discussed.

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

• Not Applicable. This is a physical medical device (catheter repair kit), not an algorithm or software. "Standalone performance" in this context would typically refer to bench testing, which is assumed to be part of the product development but not detailed as a comparative study in this 510(k) summary.

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

• Not Applicable. The concept of "ground truth" in the context of clinical data for performance assessment is not relevant to this 510(k) submission. The basis for approval is substantial equivalence to a predicate device.

8. The sample size for the training set:

• Not Applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

• Not Applicable. No training set or ground truth establishment for a training set is discussed.

In summary: The provided document is a 510(k) premarket notification that demonstrates substantial equivalence of a physical medical device (Catheter Repair Kit) to a predicate device, rather than presenting a clinical study with acceptance criteria, ground truth, or statistical performance metrics.

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