Search Results

The OPHTHALMIC YAG LASER SYSTEM YC-200 consists of a slit lamp and the YAG Laser and is indicated for the performance of posterior capsulotomy, pupillary membranectomy, iridotomy (hole in the iris) and selective laser trabeculoplasty.

The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed laser system using a 1,064 nm Q-switched pulsed Nd: YAG laser as the treatment beam source. The system consists of the types, differing only in the available types of laser emission. The two types are collectively referred to as "YC-200" throughout this 510(k). The operation mode available differs depending on the type.

As shown in the above table, the YC-200 S Plus provides the operator with two treatment modes, YAG mode and SLT mode, whereas the YC-200 type provides the operator with a single treatment mode, YAG mode. Hereafter, these two types are collectively referred to as "YC-200".

In YAG mode, treatment using the YAG treatment beam whose wavelength is 1,064 nm is available. This mode is used mainly for posterior capsulotomy and iridotomy. The 360-degree rotating two-aiming-beam system that separates the YAG aiming beam into two beams is used. The focus position is determined according to the alignment of the beams. In YAG mode, single irradiation mode and burst mode are available. In single mode, one shot of the treatment beam is emitted each time the trigger switch is pressed, whereas in burst mode, two or three shots of the treatment beam are emitted each time the trigger switch is pressed. In YAG mode, the focus shift function to shift the focal points of the YAG treatment beam on the basis of the YAG aiming beam is available. This function allows the operator to shift the focal point of the YAG beam to the posterior chamber side compared to the aiming beam in order to prevent pitting of the intraocular lens.

In SLT mode, treatment using the YAG treatment beam whose wavelength is 532 nm is available. This mode is used for selective laser trabeculoplasty. In this mode, a parfocal optical system is used. In the parfocal optical system, the image of an object surface is formed on the target surface. The SLT aiming beam is emitted from the fiber tip (the object surface) so that it appears as a sharply-edged spot on the target surface. The focus position is determined according to the projection status of the beams. In SLT mode, SLT-NAVI that assists the operator in surgery by specifying the laser emission positions and sequence before the treatment is available. The progress status of laser treatment is intuitively displayed in real time in the SLT-NAVI area of the main screen based on the premise that the treatment is proceeding as scheduled.

The system is mainly comprised of the YC-200 main body that incorporates a laser source, and a slit lamp that is similar to the previously cleared SL-2000 (K163564), head rest, the control box that controls laser emission, and a connector box.

To use the YC-200, the operator should first adjust the focus of the eyepieces to the opera-tor's refractive error and adjusts the eyepieces to the operator's pupillary distance. The operator instructs the patient to place his or her chinrest, to rest his or her forehead on the forehead rest, and to hold the grips. The operator aligns the level of the patient's eye with the eye level marker, fasten the patient's head with the head belt, and instructs the patient to look at the fixation lamp to stabilize his or her visual axis. The operator looks through the microscope to observe the treatment site. The operator sets laser emission conditions such as laser power output through the control box of the YC-200, turns on the aiming beam, and set the YC-200 to the READY mode. Alignment is achieved when the operator adjusts the joystick and contact lens to align the aiming beam focus with the target position. Finally, the operator presses the hand switch or depresses optional foot switch to emit the treatment beam in the READY mode while observing the operative field with the slit lamp.

This document is a 510(k) Premarket Notification from the FDA regarding the Nidek Ophthalmic Yag Laser System YC-200. This type of document is a regulatory approval, not a clinical study report or a technical performance testing report for an AI/ML device.

Therefore, the document does not contain the information required to answer the prompt regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device's performance.

The provided text describes the regulatory clearance process for a traditional medical device (a laser system), focusing on its substantial equivalence to previously cleared predicate devices based on indications for use, technological characteristics, and various bench tests related to laser safety, electrical safety, and usability. It does not involve AI/ML performance metrics, ground truth establishment, expert adjudication, or MRMC studies.

To directly answer your request based on the provided document, the following points would be "Not Applicable" or "Not Provided":

1. A table of acceptance criteria and the reported device performance: Not applicable for AI/ML performance metrics. The document reviews safety and performance of a laser device against standards (e.g., ISO, IEC).
2. Sample sized used for the test set and the data provenance: Not applicable. The testing described (bench testing) is for device safety and functional performance, not AI model validation on a clinical dataset.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for AI models is not relevant here.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. This device is not an AI/ML model.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

• Device Name: OPHTHALMIC YAG LASER SYSTEM YC-200
• Indications for Use: Performance of posterior capsulotomy, pupillary membranectomy, iridotomy (hole in the iris), and selective laser trabeculoplasty.
• Regulatory Class: Class II (Product Code: HQF, HJO)
• Predicate Device: Quantel Medical OPTIMIS FUSION YAG, and OPTIMIS FUSION YAG/SLT (K140336)
• Reference Devices: Lightmed Corporation LightLas SeLecTor Deux (K090774), NIDEK Slit Lamp SL-2000 (K163564)
• Testing Conducted (Bench Testing): ISO15004-1 (Ophthalmic), Z80.36 and ISO15004-2 (Light Hazard), ISO 10939 (Slit Lamp), IEC 60601-2-22 and IEC 60825-1 (Laser Product Safety), IEC 62366-1 (Usability), ANSI AAMI ES60601-1 (Electrical Safety), IEC60601-1-2 (Electromagnetic Compatibility). These tests are typically defined by engineering and performance standards, not clinical performance metrics for AI.

Therefore, for the specific request about AI acceptance criteria and study details, this document is not relevant.

Ask a specific question about this device