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The EyeQ nanoECP System is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do not allow a posterior view.

Glaucoma - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or cyclocryotherapy or other cyclodestructive procedures.

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The provided FDA 510(k) clearance letter for the EyeQ nanoECP describes the device's indications for use and regulatory classification but does not contain any information regarding acceptance criteria or the study that proves the device meets specific performance criteria.

This document is a clearance letter, which means the FDA has already reviewed the submitted data and determined substantial equivalence. The detailed performance data and study design (including acceptance criteria, sample sizes, ground truth establishment, etc.) are typically part of the 510(k) submission, which is not fully disclosed in the public clearance letter.

Therefore,Based on the provided text, I cannot extract the information required to populate the table or answer the questions about the study design that proves the device meets the acceptance criteria. The clearance letter only states that the device has been found substantially equivalent for its stated indications for use.

To answer your request, I would need access to the actual 510(k) submission summary or a more detailed performance study report for the EyeQ nanoECP.

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