(426 days)
The NGL is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:
- Retinal Photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and nonproliferative retinopathy (including diabetic);
- Choroidal neovascularization secondary to age-related macular degeneration;
- Retinal tears and detachments;
- Macular Edema;
- Retinopathy of prematurity;
- Choroidal neovascularization;
- Leaking microaneurysms.
- Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG), Acute Angle Closure Glaucoma (AACG), and Refractory Glaucoma.
- Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma.
- And other laser treatments including:
- Internal sclerostomy;
- Lattice degeneration;
- Central and Branch Retinal Vein Occlusion;
- Suturelysis;
- Vascular and pigmented skin lesions.
The NGL Ophthalmic Laser, like its predicate device Alcon Ophthalas® 532 EyeLite® (EyeLite®), is a diode pumped Neodymium-doped solid state laser designed for ophthalmic use. LASER is an acronym for "Light Amplification by Stimulated Emission of Radiation." This laser delivers a visible 532 nm green laser beam (frequency doubled), and a visible 635 mm Diode Laser aiming beam (635 nm is an approximate value between 630-640 nm). The laser firing is actuated by footswitch. The laser is delivered to the patient through any of the following accessories (a) Slit Lamp, (b) Laser Probe or (c) Laser Indirect Ophthalmoscope (LIO). In case of the NGL, like its predicate device Alcon Ophthalas® 532 EyeLite®, the laser beam is generated when a laser diode beam excites the Neodymium atoms in the rod material. When one atom which has been excited by the beam returns to its initial stable level, the energy difference between the two states is emitted as radiation in the form of a photon. When this photon meets another excited atom, emission of a second photon occurs. The second photon has the same phase, wavelength, and direction as the first photon. The light emitted in this manner oscillates between two end mirrors. The light is amplified by this stimulated emission process and a laser beam is produced. This laser beam is frequency doubled in a special crystal. The crystal is an optical dielectric that exhibits a non-linear optical response. The 532 nm wavelength is produced by harmonic generation. These steps leading to generation of the output laser beam generation is done in the laser engine module of the device. A red 635 nm laser diode provides the visible aiming beam in NGL.
This document is a 510(k) summary for the Alcon Next Generation Laser (NGL) Ophthalmic Laser, which is a medical device. This summary does not describe any acceptance criteria or studies that prove the device meets acceptance criteria related to AI/ML performance. Instead, it provides information about:
- Device Description: The NGL is a diode-pumped Neodymium-doped solid-state laser (532 nm green laser beam) for ophthalmic use, similar to its predicate device Alcon Ophthalas® 532 EyeLite®. It uses a 635 nm diode laser aiming beam.
- Indications for Use: The NGL is indicated for photocoagulation of anterior and posterior segments of the eye for various conditions, including retinal photocoagulation (for retinopathy, macular degeneration, retinal tears, etc.), iridotomy/iridectomy for glaucoma, trabeculoplasty for glaucoma, and other laser treatments like internal sclerostomy, lattice degeneration, and suturelysis.
- Predicate Devices: K962592 (Alcon Eyelite®), K041598 (Laserex™ Solitaire), K031665 (Iris Medical Oculight™).
- Nonclinical Tests and Results (Regulatory Compliance): The summary states the device will comply with applicable sections of 21 CFR 1040 and various ISO and EN standards related to medical devices, biocompatibility, electrical safety, electromagnetic compatibility, and laser product radiation safety. It also mentions that "Testing will demonstrate that the functional requirements have been met and that the system specifications have been met prior to commercial product release."
- Sterilization: The NGL console is non-sterile, while the Laser Probes are sterile (EtO sterilization) and intended for single use.
Based on the provided information, I cannot complete the requested tables and sections as there is no data related to acceptance criteria or studies concerning AI/ML performance of the device.
The document details the regulatory pathway for a conventional medical device, focusing on its physical and functional similarity to predicate devices and adherence to relevant safety and performance standards. It explicitly states that "Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed." This implies that the 'study' to prove acceptance criteria was primarily a demonstration of equivalence to existing, legally marketed devices, rather than a clinical trial with performance metrics like sensitivity, specificity, etc., typically associated with AI/ML evaluation.
Therefore, the requested information elements (table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are not present in this 510(k) summary.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.