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The VariCath Peripheral Infusion Catheter is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.

The VeinRx VariCath Peripheral Infusion Catheter is comprised of a distal occlusion balloon, a variable infusion length catheter body with infusion holes, and a proximal trifurcated Luer connection hub. The trifurcated hub allows connection to three main systems of the device. The VariCath is packaged inside a protective tube mounted on a card and placed in a sealed protective pouch.

This document is a 510(k) summary for the VariCath Peripheral Infusion Catheter. 510(k) summaries are primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results or performance metrics in the same way a PMA (Premarket Approval) would.

Based on the provided text, here's an analysis against your requested information:

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

This information is not provided in the document. The submission is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device (InfusionCath Peripheral Infusion Catheter). It does not typically require the establishment of new acceptance criteria for clinical performance or present a detailed study comparing numerical performance metrics against such criteria.

The document states:

• "The VariCath Peripheral Infusion Catheter was tested in the same manner as the InfusionCath Peripheral Infusion Catheter."
• "All components, subassemblies, and/or full devices met the required specifications for the completed tests."

This indicates that internal performance testing was conducted and met specifications, but the specifics of those specifications (acceptance criteria) and the numerical results (reported device performance) are not included in this public summary.

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

This information is not provided in the document. The submission references "testing" but does not detail a clinical test set, its sample size, or its provenance. This level of detail is usually found in a full 510(k) submission, not the summary.

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)

This information is not applicable/not provided. The device is an infusion catheter, not an AI diagnostic tool that requires ground truth established by experts for a test set.

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

This information is not applicable/not provided for the same reasons as point 3.

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/not provided. The device is a medical catheter and does not involve AI or human readers for diagnostic interpretation.

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

This information is not applicable/not provided. The device is a medical catheter and does not involve an algorithm with standalone performance.

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

This information is not applicable/not provided. The device is a medical catheter and does not involve diagnostic ground truth.

8. The sample size for the training set

This information is not applicable/not provided. The device is a medical catheter and does not involve an AI training set.

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

This information is not applicable/not provided. The device is a medical catheter and does not involve an AI training set or its associated ground truth.

In summary:

This 510(k) summary indicates that the VariCath Peripheral Infusion Catheter was found substantially equivalent to its predicate, the InfusionCath Peripheral Infusion Catheter. The basis for this equivalence is stated to be similar indications for use, function, manufacturing methods, and materials. The testing referenced is primarily for device specifications (mechanical, material, etc.), not a clinical performance study with human subjects, expert adjudication, or AI performance metrics. Therefore, most of the detailed questions regarding acceptance criteria, study design, and ground truth for AI-related device evaluation are not relevant or answered in this type of submission.

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