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The InfusaSleeve II 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™ II is a multi-lumen catheter consisting of a proximal infusion port, a proximal shaft, and a main catheter shaft which is proximal to the infusion region. An entry port for balloon and guide wire is selected with a distal 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 equivalent to the proximal infusion port. A flushing tool is included to facilitate flushing the main catheter shaft through the distal tip. The InfusaSleeve II is designed to track over standard dilatation catheters.

This document is a 510(k) premarket notification for the Kaplan-Simpson InfusaSleeve II. It establishes substantial equivalence to a predicate device and does not contain information about a study proving the device meets specific acceptance criteria in the manner described for typical AI/ML medical devices. The document details the device's technical specifications and compares them to a predicate device, along with listing nonclinical tests performed to demonstrate safety and effectiveness.

Therefore, for the requested information about acceptance criteria and a study proving device performance in the context of AI/ML, I must state that this document does not contain that information.

However, I can extract information regarding the nonclinical tests performed and the conclusions drawn from them, which serve as the basis for the device's substantial equivalence determination.

Here's a breakdown of what the document does provide, and what it does not provide, specifically addressing your numbered points:

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

   • No explicit "acceptance criteria" table is provided in the AI/ML sense.
   • The document does provide a "COMPARISON OF TECHNOLOGICAL CHARACTERISTICS" table (page 5-6) which compares the new device (InfusaSleeve II) to a predicate device (InfusaSleeve IIa). This comparison implicitly defines the performance characteristics that needed to be equivalent or superior to the predicate for substantial equivalence. The table includes:
     • General indications
     • Usage (Single use, disposable)
     • How supplied (Sterile, non-pyrogenic)
     • Sterilization method (100% Ethylene Oxide)
     • Materials (Infusion port, Proximal shaft, Main shaft & Tip, Lubricious coating, Radiopaque marker, Hard Stop, Transition marker, Support elements)
     • Design & Construction (Catheter configuration, Shaft configuration, Infusion region, Infusion side hole diameter)
     • Mode of operation (Solution delivery mode, Maximum proximal infusion pressures)
     • Infusion Pressure (psig) vs. Flow Rate (mL/min) data
     • Vascular access (Percutaneous)
     • Tracking mechanism (Over-the-balloon)
     • Size (Total length, Working length, Infusion region length, Outer diameter, Inner diameter)
     • Compatibility (Max balloon diameter, Max balloon catheter shaft size, Guiding catheter, Infusion port fitting)
     • Radiopacity (via Radiopaque distal markers)
   • The "Reported Device Performance" for the InfusaSleeve II is listed in this comparison table. For many characteristics, it is "same" as the predicate. Key numerical differences highlighted include:
     • Infusion side hole diameter: 40μm (vs. 28μm for predicate)
     • Maximum proximal infusion pressures: 100 psig (vs. 50 psig for predicate)
     • Infusion Pressure vs. Flow Rate data for InfusaSleeve II:
       • 5 psig: 3 mL/min
       • 15 psig: 7 mL/min
       • 30 psig: 13 mL/min
       • 40 psig: 17 mL/min
       • 50 psig: 20 mL/min
       • 60 psig: 24 mL/min
       • 70 psig: 27 mL/min
       • 80 psig: 31 mL/min
       • 90 psig: 34 mL/min
       • 100 psig: 38 mL/min
     • Compatibility: Max balloon diameter 4.0 mm, Max balloon catheter shaft size 3.8 Fr.

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

   • Not applicable/Not provided. This is a traditional medical device submission, not an AI/ML product tested on a data set. The "tests" mentioned are nonclinical (bench and animal) rather than data-driven.

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):

   • Not applicable/Not provided. Ground truth in the AI/ML sense is not relevant for this device.

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

   • Not applicable/Not provided.

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:

   • Not applicable/Not provided. This is not an AI/ML device.

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

   • Not applicable/Not provided. This is not an AI/ML device.

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

   • Not applicable. The "ground truth" for this device's performance relies on engineering specifications, material properties, and physical testing outcomes against known standards and the predicate device's performance.

8. The sample size for the training set:

   • Not applicable/Not provided. This is not an AI/ML device.

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

   • Not applicable/Not provided. This is not an AI/ML device.

Information Available on Nonclinical Testing from the Document:

Nonclinical Tests Performed:

• Material biocompatibility
• Bond joint tensile strengths
• Infinite fatigue (likely "infinite duration fatigue" or "endurance limit fatigue")
• Burst pressure
• Flexural properties
• Infusion rates
• Tip expansion resistance
• In vivo animal evaluations

Test Conclusions:
"The test results verified that the InfusaSleeve II performance is equivalent to, or exceeds the predicate InfusaSleeve II device performance."

This indicates that the nonclinical tests were designed to demonstrate that the new device met or surpassed the functional and safety characteristics of its predicate, thereby supporting the claim of substantial equivalence for market approval.

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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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