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The LySonix Irrigation System is intended for delivery of fluids during general surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone irrigation system. The LySonix Irrigation System is not indicated for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.

The LySonix Irrigation System is a stand-alone version of the irrigation component of the LySonix Ultrasonic Surgical System. The system is available as a tabletop unit or as part of an integrated Operative Workstation.

The provided documents are a 510(k) summary and the FDA's clearance letter for the LySonix Irrigation System. These documents confirm that the device is substantially equivalent to a predicate device, but they do not contain the specific details required to answer your request about acceptance criteria and a study proving device performance.

Here's why and what information is missing:

• 510(k) Summary Purpose: A 510(k) summary primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This often involves comparing intended use, technological characteristics, and performance data from studies (if applicable) to show that the new device is as safe and effective as the predicate. It does not typically include detailed reports of individual studies, their methodologies, acceptance criteria, or ground truth establishment.
• Missing Information: The documents do not include:
  • A table of acceptance criteria.
  • Specific reported device performance against such criteria.
  • Details about a study's sample size for a test set, data provenance, number or qualifications of experts, adjudication methods.
  • Information about MRMC comparative effectiveness studies or standalone algorithm performance.
  • The type of ground truth used, training set size, or how ground truth for the training set was established.

What the document does state regarding performance, but without the requested detail:

• Substantial Equivalence: The key "proof" in a 510(k) submission like this is the demonstration of substantial equivalence. The document states: "The LySonix Irrigation System is equivalent to the irrigation component of the LySonix Ultrasonic Surgical System in terms of intended use, design, operating principles, materials and performance." (Page 0)
• This statement implies that the performance of the LySonix Irrigation System was assessed and found to be on par with its predicate, but it doesn't describe how that performance was assessed, what specific metrics were used, or what acceptance criteria were applied in any study.

To answer your request comprehensively, one would need access to the full 510(k) submission, which would contain detailed testing protocols, results, and analyses. The summary provided here is a high-level overview for public disclosure, not the full technical report.

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