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The Supercath V fistula catheter is intended to access a vein or artery while connected to a blood circuit during kidney dialysis. The Supercath V is intended to minimize inadvertent needlesticks or is intended to reduce accidental needlesticks.

The SUPERCATH V fistula catheter is part of any hemodialysis system that connects the patient to the machine and provides access to the patient's blood. This device is designed for single use and the catheter hub has a built-in hemostatic valve, which assists compression hemostasis when the metallic introducer needle is withdrawn following blood vessel puncture. The metallic introducer needle is retracted into the extendable needle casing to prevent needlestick injury.

The provided text is a 510(k) Premarket Notification for the "Supercath V" device. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, the requested information elements related to acceptance criteria, device performance metrics, sample sizes for test/training sets, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this type of regulatory submission.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the regulatory decision is based on comparing the new device's characteristics and intended use to previously cleared devices, not on a new clinical performance study with predefined acceptance criteria.

However, I can extract the following relevant information based on the request and the provided text:

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

• This information is not provided in the 510(k) submission. The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use compared to predicate devices, not on meeting specific, quantitative performance acceptance criteria from a study.

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

• Not applicable/Not provided. No dedicated test set or clinical study data is reported for performance evaluation against acceptance criteria.

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

• Not applicable/Not provided. Ground truth establishment for a test set is not part of this type of submission.

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

• Not applicable/Not provided.

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/Not provided. This device is a medical catheter, not an AI-assisted diagnostic tool.

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

• Not applicable/Not provided. This device is a medical catheter and does not involve an algorithm.

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

• Not applicable/Not provided. Ground truth is not established in this type of submission.

8. The sample size for the training set:

• Not applicable/Not provided. Training sets are not relevant to this type of device and submission.

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

• Not applicable/Not provided.

The available information related to "acceptance criteria" is purely for the purpose of demonstrating "substantial equivalence" to predicate devices, as shown in the comparison table:

Table of Substantial Equivalence Comparison (from "Comparison Table 1")

Conclusion regarding Substantial Equivalence:

The document concludes that the Supercath V is substantially equivalent to the listed predicate devices because:

• It has the "same intended use" as Togo Medikit's Supercath A.V. Fistula (K854773).
• It has "similar technological characteristics" as the PROTECTIV PLUS Safety IV Catheter (K030571) and the Supercath Z3V (K050114).
• "Similar component materials are used as in prior Supercath models cleared by FDA."

This type of submission relies on demonstrating that the new device does not raise new questions of safety or effectiveness compared to existing, legally marketed devices, rather than presenting a performance study with acceptance criteria.

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