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The XO Cath Microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic or therapeutic materials into the vessel.

The subject XO Cath Microcatheter is a single-lumen, metal alloy shaft with micro-cuts for flexibility, designed to support a guidewire during access of the peripheral vasculature, and to provide a conduit for the delivery of embolic applications. The XO Cath Microcatheter is available in two lumen sizes, 2.0Fr and 2.6Fr.

The XO Cath 2.0Fr and 2.6Fr Microcatheters are available with a straight or bern tip shape to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. Radiopaque markers are located at the distal tip to facilitate fluoroscopic visualization. The proximal end incorporates a standard luer for ease of use and to connect with a syringe.

The provided text describes a 510(k) premarket notification for the XO Cath Microcatheter, demonstrating its substantial equivalence to a predicate device. It is a medical device, specifically a microcatheter, and therefore the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance bench testing conducted to demonstrate its functional equivalence to the legally marketed predicate device, rather than a clinical study or AI model validation study.

Here's a breakdown of the requested information based on the provided text, focusing on the device performance testing rather than a software algorithm or AI model:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All data met pre-determined acceptance criteria," but it does not explicitly list the numerical acceptance criteria for each test or the specific numerical results for the XO Cath Microcatheter. Instead, it relies on a comparative analysis to the predicate device.

Table: Acceptance Criteria and Reported Device Performance (as inferred from the text)

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

The document describes bench testing and biocompatibility testing rather than a "test set" of patient data for an algorithm. Therefore, "sample size" here refers to the number of devices or materials tested. The exact sample sizes for each bench test are not specified in this summary.

• Data Provenance: The testing was conducted by Transit Scientific, LLC, to support a 510(k) submission to the FDA. This implicitly means the testing was performed in a controlled laboratory environment, likely in the US, and is prospective in the sense that the testing was specifically designed and executed to gather data for this submission.

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

This question is not applicable to this document. The submission is for a physical medical device (microcatheter), not an AI/software device that requires expert ground truth labeling of patient data. The "ground truth" for this device's performance is established through adherence to engineering specifications, recognized standards, and direct comparison to a predicate device's established performance characteristics via bench testing.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers are evaluating and labeling data (e.g., radiology images) to establish a consensus "ground truth" for a dataset. This document concerns a physical device's performance through bench testing, not human interpretation of data.

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 question is not applicable. An MRMC study is relevant for AI/software devices where human readers' performance with and without AI assistance is being evaluated. This document is for a physical microcatheter and does not involve AI or human image interpretation studies.

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

This question is not applicable. This submission is for a physical medical device, not a standalone algorithm.

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

For this type of device, the "ground truth" is established by:

• Adherence to engineering specifications and design requirements.
• Compliance with recognized industry standards (e.g., ISO 10993-1 for biocompatibility).
• Performance characteristics demonstrated through rigorous bench testing that simulate clinical use conditions and measure physical properties (e.g., flow rate, pressure resistance, kink resistance).
• Comparison to the established performance profile of the predicate device. The predicate device itself serves as a benchmark of "safe and effective."

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This question is not applicable. There is no "training set."

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