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ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Clamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White (corneal diameter) and Pupil Size. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.

The ARGOS is substantially equivalent to the predicate device identified previously: - the ARGOS (Santec Corporation) that was cleared by the FDA on October 2nd, 2015(K150754) as the primary predicate as it has the most similar intended use and characteristics - the IOLMaster 700 (Carl Zeiss Meditec) that was cleared by the FDA on June 29, ● 2015 (K143275, K170171) as an additional (secondary) predicate to support a new feature of reference image capture on the version of ARGOS in this submission. The predicate devices are Class 2 devices to premarket notification, as defined per regulation number 21 CFR 886.1850. In addition, the predicate devices have product codes of MXK(ARGOS), and HJO(IOLMaster700). The version of ARGOS in this submission is a modified version of the Argos cleared under K150754 which is substantially equivalent with regard to intended use, operating principle, function, materials, and energy source. The differences from the predicate ARGOS (K150754) that are subject of this 510(k) submission are: - An additional feature of reference image capture function ● - Labeling change including change in the intended use adding the feature of reference . image capture. - . This image can be transferred to image guided devices in order to support the execution of preoperative plan. The changes described in this submission do not affect how the hardware is used to acquire measurements as a biometer, nor do these changes affect the principle of operation of the device.

ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraccular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White (corneal diameter) and Pupil Size. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.

Argos is a swept-source based biometer that provides the biometry and keratometry of the eye prior to cataract surgery and aids in the selection of the appropriate IOL. Argos processes 3 OCT images (B-scans) and 3 CMOS camera images per measurement in seconds - reducing procedure time and minimizing patient discomfort. From the OCT images the biometry parameters are evaluated by segmenting the cornea, iris, lens, and retina. The operator can edit the biometry parameters by manual adjustment: Axial length, Corneal thickness, Anterior chamber depth (or aqueous depth), Lens thickness, White-towhite (corneal diameter), Pupil size. The keratometry values: K-values (flattest and steepest meridians), Astigmatism (angle of flattest meridian), are evaluated from the CMOS camera image, in combination with the OCT information. All distance/thickness parameters (Axial length, Corneal thickness, Anterior chamber depth, Lens thickness, White, Pupil size) are simultaneously measured from 2dimensional OCT images. All the boundaries of ocular segments are detected and distances and thicknesses are calculated by taking into account the refractive indices of each medium. Axial length is the distance from the corneal apex to the fovea or, more specifically, to the ILM (Internal Limiting Membrane). The calculation is performed as the sum of the thicknesses (after refraction correction) of the cornea, aqueous humor, lens and vitreous. Corneal thickness is the distance between the anterior and the posterior apexes of the cornea divided by the cornea refractive index (1.375). Aqueous depth is evaluated as the distance between the posterior surface of the cornea and the anterior surface of the lens divided by the refractive index (1.336). Anterior chamber depth is the sum of corneal and aqueous humor distances. Lens thickness is the distance between the anterior and the posterior surfaces of the lens divided by its refractive index (1.410). Pupil size is the lateral distance between the two inner boundaries of the iris region. White-to-white (Corneal diameter) is the lateral distance between the inner boundaries of the cornea-sclera interface. K-values (Radii of flattest and steepest meridians) and Astigmatism are evaluated by the size and distance of the reflected images of the infrared LED ring projected onto the cornea. Safety protocol is well integrated into the device in both hardware and software to ensure the safety of both the patient and the operator. The control program on the computer runs on Windows. The operation panel on the display attached to the PC provides all the functionalities. IOL calculation uses widely recognized formulas; Hoffer Q, Haigis, Holladay1, SRK/T, etc.