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The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a noncontact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.

The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.

It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects.

The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2)is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) with System linkage software (herein referred to as "Maestro2") is a non-contact ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography. Maestro2 includes an optical system of OCT, fundus camera (color. IR and Red-free image), and anterior observation camera. The color fundus camera acquires color images of the posterior segment of the eye under mydriatic or non-mydriatic conditions. Maestro2 is used together with IMAGEnet6 by connecting via System linkage software which is a PC software installed to off the shelf PC connected to Maestro2. The remote operation function is not intended to be used from any further distance (e.g., operation from different rooms or different buildings) other than social distancing recommendations.

This document is a 510(k) summary for the Topcon 3D Optical Coherence Tomography 3D OCT-1 (type: Maestro2) with System linkage software. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a performance study with detailed acceptance criteria for an AI/algorithm-driven diagnostic device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, especially in the context of AI/algorithm performance. It primarily addresses the device's technical specifications, intended use, and conformance to general medical device standards.

Specifically, it states:

• "This section is not applicable because clinical data was not required for this 510(k) submission." (Page 6)
• The substantial equivalence discussion highlights that the main difference in the subject device is the "system linkage software" and an "optional remote operation function." For the remote operation function, it states that "comparison testing confirmed that image quality and diagnosability is the same with or without the remote operation function." This is a functional comparison, not a clinical performance study with defined acceptance criteria for diagnostic output.

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