NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)

• K Number: K973533
• Device Name: NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
• Manufacturer: NIDEK, INC.
• Date Cleared: 1997-11-04 ( 47 days)
• Product Code: HKI
• Regulation Number: 886.1120
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

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.

Device Description

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

AI/ML Overview

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.

Regulation Number and Section

§ 886.1120 Ophthalmic camera.

(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.