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Model 3-DX captures simultaneous stereo photographs of disc/ fundus area on a single frame - suitable picture angle for stereoscopic optic disc glaucoma diagnosis.

Model 3-DXF has an additional fluorescence angiography capability to 3-DX.

Nidek 3-DX/3-DXF Stereo Disc/Fundus Cameras

The provided document is a 510(k) clearance letter from the FDA for the "Nidek 3-DX/3DXF Stereo Disc/Fundus Cameras." This document grants market clearance based on a determination of substantial equivalence to a legally marketed predicate device.

Crucially, this document does not contain information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or ground truth establishment.

The 510(k) process primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, not necessarily on proving performance against specific acceptance criteria through a dedicated study.

Therefore, I cannot populate the requested table and answer the study-related questions based on this document. The information typically requested in your prompt (acceptance criteria, specific study results, sample sizes, ground truth details) is usually found in a separate clinical study report or a detailed premarket submission document, which is not provided here.

The document only states the "Indications For Use" for the devices:

• Model 3-DX: Captures simultaneous stereo photographs of disc/fundus area on a single frame - suitable picture angle for stereoscopic optic disc glaucoma diagnosis.
• Model 3-DXF: Has an additional fluorescence angiography capability to 3-DX.

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