(143 days)
LightLas Lpulsa SYL-9000: Photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including posterior capsulotomy and pupillary membranectomy. LightLas SeLecTor Deux: Photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including posterior capsulotomy, pupillary membranectomy and selective laser trabeculoplasty. LightLas LaserLink : Laser delivery system for use by an ophthalmologist in the treatment of ocular tissue. The laser delivery system is intended for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, General Intended Use section. LightLas SecLeTor Trois: (SeLecTor Deux with LightLas 532 or 561 or 810) Photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including posterior capsulotomy, and pupillary membranectomy, retinal photocoagulation and selective laser trabeculoplasty. The intended use has not changed from the predicate devices (K081704)
The LightLas Family of Medical Laser System is a fully integrated, high-performance diagnostic slitlamp and therapeutic laser delivery system. The System is also an ophthalmic surgical laser designed for performing photodisruption and photocoagulation. For ocular tissue using laser energy emitted by a Nd: YAG laser including posterior capsulotomy, pupillary membranectomy and selective laser trabeculoplasty. The LightLas Family of Medical Laser System produces short, individual pulses of focused laser light with wavelengths of either 1064nm to 532nm, depending on the selected operational mode. Using a slitlamp microscope and aiming beam, the pulsed light is accurately targeted on a structure within the patient's eye. There are several packages for treatment selectable. The LightLas Family of Ophthalmic Lasers is comprised of: LightLas Lpulsa SYL-9000 (K990075): A Nd: YAG laser providing laser pulses at a wavelength of 1064 nm for use in photodisruption of ocular tissue (posterior capsulotomy and pupillary membranectomy). LightLas SeLecTor Deux: A Nd: YAG laser providing laser pulses at a wavelength of 1064 nm for use in photodisruption or frequency doubled YAG laser pulses at a wavelength of 532nm for use in selective laser trabeculoplasty, depending on the mode selected. LightLas LaserLink : Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared LightLas 532/561/810 retinal photocoagulator to allow use of the slit lamp to deliver 532/561/810 nm continuous wave laser energy for retinal photocoagulation. LightLas SeLecTor Trois: A Nd:YAG laser providing laser pulses at a wavelength of 1064 nm for use in photodisruption, Frequency Doubled YAG Laser pulses at a wavelength of 532 nm for use in selective laser trabeculoplasty, or 532 nm continuous wave laser energy for retinal photocoagulation, depending on the mode selected. The Trois is a LighLas SeLecTor Deux with one of LightLas system. LightLas SeLecTor Trois suitable for follow unit: 1. LightLas 532 : K010372 2. LightLas 561: K063297 3. LightLas 810: K021538
The provided text is a 510(k) summary for the LightLas Family of Medical Laser System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with acceptance criteria.
Therefore, the input document does not contain the information requested to fill out a table of acceptance criteria and reported device performance based on a study, nor does it provide details about such a study.
Here's what can be inferred from the document regarding a "study":
- No specific clinical study is described. The document states, "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the LightLas Family of Medical Laser System." This phrase indicates that engineering and bench testing were performed to demonstrate that the new device performs similarly to predicate devices, adhering to established performance standards (21 CFR 1040.10 & 1040.11). It does not mention a clinical trial or a study designed to evaluate specific performance metrics against pre-defined acceptance criteria in a patient population.
- Focus on Substantial Equivalence: The core of a 510(k) submission is to prove that the new device is "substantially equivalent" to a predicate device already on the market. This typically involves comparing technological characteristics and intended uses, and sometimes non-clinical performance data, rather than conducting new clinical trials with acceptance criteria for clinical outcomes.
Therefore, I cannot generate the requested table or answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies because this information is not present in the provided 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.