(13 days)
The Lysus® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The system consists of a disposable infusion catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor transducer temperature.
I am sorry, but based on the provided FDA documents (a 510(k) clearance letter and a 510(k) summary), the information required to answer your request about acceptance criteria and a study proving device performance is not present.
The documents indicate that the Lysus Infusion System was cleared based on substantial equivalence to a previously marketed device (K041629) and refer to "testing and evaluations performed" in the summary. However, they do not:
- Provide a table of specific acceptance criteria.
- Report detailed device performance metrics.
- Describe the sample size, data provenance, number or qualifications of experts, or adjudication methods used in any specific study.
- Mention a multi-reader multi-case (MRMC) comparative effectiveness study or report an effect size for human reader improvement with AI assistance.
- Provide details about a standalone algorithm performance study.
- Specify the type of ground truth used for any testing.
- Provide the sample size for a training set or how ground truth for a training set was established.
The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, which often relies on comparison of technological characteristics, intended use, and sometimes non-clinical performance data, rather than detailed clinical effectiveness studies with the kind of ground truth and reader studies you are asking about, especially for lower-risk devices.
Therefore, I cannot fulfill your request with the given input.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).