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The InfusaSleeve IIa is intended to infuse fluids such as heparinized saline, diagnostic agents such as contrast media, and thrombolytic agents such as urokinase into the coronary vasculature. The catheter is designed for use with a commercially available dilatation catheter to facilitate selective and subselective access and regional infusion.

The Kaplan-Simpson InfusaSleeve™ IIa is a multi-lumen catheter consisting of a proximal infusion port, a proximal shaft, and a main catheter shaft with a distal infusion region. An entry port for balloon and guide wire access is located at the proximal end of the main shaft which is proximal to the infusion region. The infusion region consists of four separate infusion lumens each with multiple sideholes. Radiopaque markers are located within the infusion region. Infusion solution is delivered through the proximal infusion port, through the four infusion lumens and exits through the sideholes into the coronary vasculature. A standard luer adapter allows for attachment of a syringe with a manometer or equival infusion port. A flushing tool is included to facilitate flushing the main catheter shaft through the distal tip. The InfusaSleeve IIa is designed to track over standard dilatation catheters.

The provided text outlines a 510(k) summary for the InfusaSleeve IIa (IS-2a) catheter, mainly focusing on its substantial equivalence to a predicate device, the InfusaSleeve II.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., a specific percentage for sensitivity or specificity). Instead, it relies on demonstrating equivalence to a predicate device through various non-clinical tests. The "reported device performance" is framed as being "equivalent to, or exceeds" the predicate device.

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

The document does not explicitly state specific sample sizes for each non-clinical test. It mentions "Material biocompatibility, bond joint tensile strengths, infusion pathway fatigue, burst pressure, infusate flow, torque strength, histology, and in-vivo animal evaluations."
The data provenance is from non-clinical tests, including in-vivo animal evaluations. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective, though in-vivo animal evaluations are typically prospective for such device testing.

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

This information is not provided in the document. For non-clinical tests, "ground truth" often refers to predefined engineering specifications or biological endpoints, rather than expert consensus on interpretations of images or clinical outcomes.

4. Adjudication method for the test set

This information is not provided in the document. With non-clinical tests, adjudication methods like 2+1 or 3+1 are typically not applicable. Test results are objectively measured against predefined criteria.

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, an MRMC comparative effectiveness study was not done. This document describes the clearance of a physical medical device (catheter) for infusing fluids, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

No, a standalone algorithm performance evaluation was not done. This is a physical device, not an algorithm.

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

The ground truth for the non-clinical tests would have been based on predefined engineering specifications, material standards, and biological endpoints from animal studies. For example:

• Engineering specifications: For burst pressure, torque strength, tensile strength, and flow rates.
• Material standards: For biocompatibility.
• Biological endpoints: For histology (e.g., absence of inflammation, tissue damage) and in-vivo animal evaluations (e.g., functional performance, safety, absence of adverse events).

8. The sample size for the training set

This information is not applicable as this is a physical medical device and not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable as this is a physical medical device and not an AI/machine learning algorithm requiring a training set with established ground truth.

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