Search Results

The MicroSTAAR ™ Indigo Injector Foam Tip System is a device intended to fold and insert STAAR Surgical one and three piece Collamer® lenses for surgical placement in the human eye.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "MicroSTAAR™ Indigo Injector Foam Tip System." This letter grants market clearance based on a finding of "substantial equivalence" to legally marketed predicate devices, not on the results of a clinical study demonstrating the device meets specific acceptance criteria in the manner that an AI/ML device would be evaluated.

Therefore, the information requested in your prompt (e.g., acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not present in this document.

This document is for a Class I medical device (intraocular lens guide) and focuses on regulatory clearance rather than a detailed performance study as would be required for a novel AI/ML diagnostic or prognostic device. The 510(k) process for this type of device typically relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety or effectiveness.

In summary, this document does not contain the information necessary to answer your request regarding acceptance criteria and a study proving a device meets those criteria, as it pertains to AI/ML device evaluation.

Ask a specific question about this device