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The Green Laser Photocoagulator GYC-500 is intended to be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

The Green Laser Photocoagulator GYC-500 ("GYC-500") is a laser photocoagulator for ophthalmology using the 532 nm diode-pumped solid-state laser (green laser beam) as the treatment beam and 635 nm diode laser (red laser beam) as the aiming beam. Like other conventional laser photocoagulation system, the GYC-500 can be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty. The GYC-500 is a modified version of the GYC-1000 which was the subject of premarket notification number K 032085.

The GYC-500 is mainly comprised of the main body that incorporates a laser source, the control box that controls laser emission, and a delivery unit that guides the laser beam emitted from the main body to the patient's eye.

To use the GYC-500, the operator sets laser irradiation conditions such as laser output and laser application time according to the condition of treatment site through the control box of the GYC-500 or operation part of the connected delivery unit. When using a (attachable) slit lamp delivery unit, the operator observes the treatment site with the slit lamp, and aligns the treatment beam and aiming beam to the site. Then the operator presses the foot switch to emit the treatment beam and aiming beam to the treatment site from the exit end of the GYC-500 system in a READY status while observing the operative field with the slit lamp. As the treatment beam is optically coaxial to the aiming beam, alignment is achieved when the user aligns the aiming beam to the treatment site. When the foot switch is pressed under the condition, the treatment beam of the set spot size is irradiated at which the aiming beam is projected. The operator can also select the laser irradiation pattern from a single laser spot and multiple laser spots in a predetermined pattern in a scanning manner.

Various types of the delivery units are available for the GYC-500. As the delivery units using a slit lamp, broadly speaking, two types of delivery units are available. One is called "Slit lamp delivery unit" integrating a slit lamp and a laser delivery unit. The other is called "Attachable delivery unit" that is the laser delivery unit integrating a protective filer and so on for connection to the slit lamp owned by the user. Either the slit lamp delivery units or attachable delivery units are divided into three types: 1) the unit only with the fixed protective filter that remains inserted into the optical path and without the micromanipulator (used for fine adjustment of the laser beam position), 2 ) the unit with the fixed protective filter or electrically-powered one (either filter is factory configured) and with the micromanipulator, and 3) the unit only with the electrically-powered protective filter, with the micromanipulator, and with the spot size control which is different from the aforementioned two types in mechanical structure.

Furthermore, the slit lamp delivery units are classified into "Slit lamp delivery unit" that delivers a single laser spot only, and "Scan slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. In a similar manner, the attachable delivery units are further classified into "Attachable slit lamp delivery unit" that delivers a single laser spot only, and "Scan attachable slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. The GYC-500 connected with a scan (attachable) delivery unit is called "Green Scan Laser Photocoagulator GYC-500 Vixi".

Various slit lamp delivery units are available that allow for the adaptation of the GYC-500 to a slit lamp. A fiber optic cable is connected from the GYC-500 main body to the slit lamp, thereby allowing the laser beam to be sent to the delivery unit. With the delivery unit, the patient can be treated in a seated position. The following slit lamp types are available: Slit lamp delivery unit (NIDEK SL-1800 type), Scan slit lamp delivery unit (NIDEK SL-1800 type), Attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type, ZEISS 30 SL/M type, HAAG 900BM/900BQ type), and Scan attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type, ZEISS 30 SL/M type, HAAG 900 BQ type).

Other than the (scan and/or attachable) slit lamp delivery units, a binocular indirect ophthalmoscope (B.I.O.) delivery unit and a combination delivery unit are available.

The B.I.O. delivery unit allows the operator to perform photocoagulation while observing the fundus with a binocular indirect ophthalmoscope. With the delivery unit, the patient can be treated in a supine position. The B.I.O. delivery unit (Heine Omega 500 type and Keeler All Pupil II type) connects to the GYC-500 main body via a fiber optic cable. The B.I.O. delivery unit consists of a binocular indirect ophthalmoscope (with headband), a 20 D condensing lens illumination lamp, and stand. The headband fits over the operator's head and has height and circumference adjustment knobs. A working distance control sets the working distance, which can be varied within a range of 300 to 700 mm. The treatment and aiming laser spot size can also be selected by changing working distance (with the 20D condensing lens).

The combination delivery unit is mounted on the NIDEK Ophthalmic YAG Laser System YC-1800's slit lamp and is connected to the GYC-500 main body using a connecting cable and a fiber-optic cable. The delivery unit allows the operator to perform photocoagulation using the green laser beam (532 nm) or photodisruption using an Nd: YAG laser beam while performing observation of the eye with the slit lamp of the YC-1800. The optical path for the green laser beam is completely independent from that for the Nd: YAG laser pulse beam. The operator selects the laser beam to be emitted by switching the optical path using the laser beam selector of the delivery unit. This delivery unit is intended to save the area occupied by the slit lamp for the GYC-500 and that for the YC-1800 by using the slit lamp of the YC-1800 consistently for both photocoagulation and photodisruption.

The delivery units allow transpupillary photocoagulation using a slit lamp or binocular indirect ophthalmoscope. The operator chooses the optimal delivery unit for the purpose of photocoagulation of the patient's eye.

The provided text describes a 510(k) premarket notification for a medical device called the Green Laser Photocoagulator GYC-500. This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

Instead, this document is a regulatory submission for a traditional medical device (a laser photocoagulator) and focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "testing in support of substantial equivalence determination" mentioned are standard bench tests for electrical safety, software validation, and ophthalmic device-specific standards, not performance metrics related to diagnostic accuracy, sensitivity, or specificity that would be typical for an AI-powered device.

Therefore, I cannot provide the requested information for an AI-powered device based on this document. The document pertains to a device where performance is evaluated against established technical and safety standards for laser systems, not against accuracy metrics for an AI algorithm.

If this were an AI-powered device, the requested information would typically include details about classification performance (e.g., sensitivity, specificity, AUC) and an evaluation of its clinical impact, which are absent here.

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