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The TransXchange Support Catheter is a guidewire exchange and infusion device designed for use in the peripheral vascular system. The catheter is intended to support a guidewire during access of vessels, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The TransXchange Support Catheter is designed to perform the following functions during percutaneous intravascular procedures:

1. Support a 0.014" guidewire during introduction of catheters with lumens of 0.035" or greater over a 0.014" guidewire. The TransXchange Support Catheter is designed to assist in the introduction of catheters with lumens of 0.035" or greater over a 0.014" guidewire. The TransXchange Support Catheter acts to fill the annular space between the smaller guidewire and larger catheter lumen.
2. Allow for the exchange of guidewires through its lumen
3. Infusion of fluids such as saline or diagnostic contrast agents through its lumen into the vascular system using pressures up to 150 psi

The TransXchange Support Catheter in constructed of 5 components: a single lumen high density polyethylene tubing with a tapered distal tip, a proximal female luer hub, a two piece strain relief constructed of polyolefin, a distal platinum iridium marker band, and Loctite 4304 Cyanoacrylate Adhesive.

This document describes a 510(k) premarket notification for the "TransXchange Support Catheter" by Medtronic Vascular. This type of submission focuses on proving "substantial equivalence" to a predicate device, rather than independent performance acceptance criteria and a detailed clinical study for novel devices.

Here's an analysis of the provided information regarding acceptance criteria and studies:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table for this device. The focus is on demonstrating "substantial equivalence" to a predicate device, the Spectranetics Support Catheter (K991059).

Instead of specific numerical targets, the acceptance criteria for this 510(k) submission are inferred to be:

• Ability to perform intended functions:
  • Support a 0.014" guidewire during the introduction of larger catheters.
  • Allow for the exchange of guidewires.
  • Infuse fluids (saline or contrast agents) at pressures up to 150 psi.
• Safety and Effectiveness: Demonstrated through biocompatibility and non-clinical (preclinical) testing.
• Sterility: The device must be provided sterile and not intended for reuse or resterilization.
• Substantial Equivalence: The primary "acceptance criterion" of a 510(k) is to prove that the device is as safe and effective as a legally marketed predicate device.

The reported device performance is described qualitatively as:

• "The subject and predicate stents are identical technology and are intended to support a guidewire during access of the vasculature, to allow for the exchange of guidewires, and to infuse saline or diagnostic contrast agent."
• "The subject device offers a smaller catheter diameter." (This is a design difference, not a performance metric per se, but it implies a performance characteristic in terms of access).
• "Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device." (No specific results are provided).
• "The TransXchange Support Catheter... meets clinical needs of the physicians."

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 "test set" in the context of human clinical data or a specific sample size for such a set. The "testing" referred to is "Nonclinical testing" to confirm "safe and effective performance" and "biocompatibility." These are typically bench tests or in vitro/ex vivo studies, not clinical trials with human subjects. Therefore, details like data provenance or retrospective/prospective nature are not applicable here.

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)

No information is provided about experts used to establish ground truth because there is no mention of a human clinical test set in this document.

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

No adjudication method is mentioned as there is no human clinical test set described.

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

No such study was conducted or mentioned. This device is a physical catheter, not an AI-powered diagnostic tool, so MRMC studies and AI assistance metrics are not relevant.

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

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

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

Given the nature of the device and the submission (510(k) for substantial equivalence based primarily on non-clinical testing), the "ground truth" or validation would come from:

• Engineering specifications and standards: Confirming the catheter's physical properties, material compatibility, and functional performance (e.g., ability to support a guidewire, flow rates at specific pressures, burst pressure, fatigue resistance).
• Biocompatibility testing results: Adherence to established standards for biological safety.
• Comparison to the predicate device: The predicate device itself (Spectranetics Support Catheter K991059) represents a "ground truth" of a legally marketed and presumably safe and effective device. The "truth" for the new device is that it performs "substantially equivalently" to this predicate.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set mentioned.

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