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The Lysus" Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The Lysus® Infusion System is an infusion catheter system designed to deliver fluids via a multi sidehole catheter. The fluid is dispersed via multiple ultrasound transducers distributed linearly along the length of an ultrasound core which is placed into the center lumen of the catheter. This device is intended to deliver physician-specified agents or fluids into the peripheral vasculature.

This is a 510(k) premarket notification for a medical device (Lysus Infusion System), not a clinical study report. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for clinical performance evaluations, is not present in the provided document.

A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study. The performance section in a 510(k) summary typically references preclinical (bench and animal) studies to demonstrate design specification adherence, safety, and effectiveness.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

Information Extracted from the Provided Document:

• Device Name: Lysus® Infusion System
• Intended Use: "The Lysus® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature."
• Device Description: "The Lysus® Infusion System is an infusion catheter system designed to deliver fluids via a multi sidehole catheter. The fluid is dispersed via multiple ultrasound transducers distributed linearly along the length of an ultrasound core which is placed into the center lumen of the catheter. This device is intended to deliver physician-specified agents or fluids into the peripheral vasculature."
• Type of Studies Mentioned: "EKOS has conducted preclinical bench and animal studies with the Lysus® Infusion System. These studies demonstrate that the performance of the Lysus® Infusion System meets its design specifications and is safe and effective for its intended use."

Information NOT available in the provided document (and why):

1. A table of acceptance criteria and the reported device performance: This document is a summary of the 510(k) submission, not the full submission itself, nor a clinical study report. It states that the device "meets its design specifications," but doesn't list those specifications or the performance against them.
2. Sample sizes used for the test set and the data provenance: The document mentions "preclinical bench and animal studies" but does not provide details of sample sizes, control groups, or whether the data was retrospective or prospective. It certainly doesn't mention human test sets, as this is a 510(k) premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Preclinical studies typically don't involve expert ground truth establishment in the same way clinical studies do.
4. Adjudication method for the test set: Not applicable for preclinical studies as 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: Not applicable. This device is an infusion system, not an AI diagnostic tool, and the document describes preclinical testing, not comparative clinical effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for the preclinical studies. In bench studies, "ground truth" would be engineering measurements and physical standards. In animal studies, it would be physiological and histological observations.
8. The sample size for the training set: Not applicable. This is not an AI device that undergoes a "training set" process.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory notice for a 510(k) clearance, which relies on demonstrating substantial equivalence to a predicate device via preclinical data, not on a detailed clinical study proving specific acceptance criteria in humans.

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