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The DuoFlo™ Catheter is intended for general intravascular use in the peripheral vasculature in arteries 3.5 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer. The DuoFlo™ Catheter is contraindicated for use in the coronary and intracranial arteries. The DuoFlo™ Catheter is not intended for embolic protection or as an aspiration catheter.

The DuoFlo™ Catheter is a sterile single use device that consists of concentric shafts with four lumens with access via Luer connectors as follows, one for balloon inflation, one for pressure monitoring and two concentric lumens for infusate injection or extracorporeal circuit connections. The central through lumen accepts up to a 0.038" guidewire.

The provided text is a 510(k) summary for the ThermopeutiX DuoFlo Catheter (Heparin Coated). This document is primarily focused on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves a device meets specific acceptance criteria in the way a diagnostic software or AI model might.

Here's an analysis based on the available information, addressing your specific points where possible, and noting where information is not present in the provided text:

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

The document does not present specific quantitative acceptance criteria or detailed performance results in the format typically used for a diagnostic device's clinical study. The device is a "Temporary Intravascular Occluding Catheter" and the focus is on its safety and equivalence.

2. Sample size 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 given text. The document refers to "biocompatibility studies" but does not detail their methodology, sample sizes, or data provenance. This is a medical device clearance, not typically a clinical trial for a diagnostic algorithm.

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/provided. The ground truth establishment by experts is relevant for diagnostic AI/software evaluations, not for the clearance of a mechanical catheter based on substantial equivalence and biocompatibility.

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

This information is not applicable/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

An MRMC study is not applicable/provided. This device is a catheter, not an AI or imaging diagnostic tool.

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

A standalone performance study is not applicable/provided. This device is a physical medical instrument, not a software algorithm.

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

The "ground truth" in this context revolves around:

• Biocompatibility: Adherence to ISO standards, likely demonstrated through in vitro and in vivo testing (e.g., cytotoxicity, sensitization, irritation, genotoxicity, hemocompatibility studies).
• Sterility: Verification of the sterilization process to achieve the specified SAL.
• Physical/Mechanical Properties: Verification that the design and construction are identical to the predicate (except for the coating), which implies similar mechanical performance.
• Heparin Coating Efficacy (implied): The claim that the heparin helps minimize thrombus formation would ideally be supported by in vitro or in vivo studies demonstrating reduced thrombus compared to the uncoated predicate. However, detailed data for this is not presented in the summary, only the claim is made.

8. The sample size for the training set

This information is not applicable/provided. A "training set" is relevant for machine learning algorithms, not for the type of device being described.

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

This information is not applicable/provided. (See point 8).

Summary of the Study Mentioned (as much as can be gleaned):

The primary "study" mentioned for the ThermopeutiX DuoFlo™ Catheter (Heparin Coated)'s performance and safety is:

• Biocompatibility Studies: These were conducted on the patient contact materials in accordance with ISO 10993-1 standards. The exact details (e.g., specific tests, sample sizes, animal models if any) are not provided in this summary, but the claim is that biological safety has been "demonstrated."
• Sterility Validation: The device's sterility "conforms to a Sterility Assurance Level (SAL) of 10⁻⁶." This indicates that sterilization processes were validated to meet this standard.

The overall approach for this 510(k) is demonstrating substantial equivalence to a predicate device (K080700). The "study" largely consists of showing that the device is identical in design and construction, with the only change being the addition of a bound heparin coating. The safety of this change hinges on the biocompatibility studies of the new material and the claim that the heparin helps minimize thrombus, implying it's a beneficial addition without new safety concerns. No comparative clinical effectiveness study against the predicate is described in this document to quantify improvement due to the heparin coating.

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