Search Results

There are four selected wavelengths (532nm, 577mm, 810mm) in TruScan Pro Laser Console integrated with single/multi spots of TruScan module integrated with slitlamp or single spot of LIO or endo ocular probes.

The 532nm and 810nm laser wavelengths are intended to be used for:

• · Pan-retinal photocoagulation for proliferative diabetic retinopathy- with Slitlamp or Endoprobe
• · Laser retinopexy for retinal tear and detachments with Slitlamp or Endoprobe
• · Focal or grid photocoagulation for clinically significant macular edema (CSME)- with Slitlamp
• Focal photocoagulation for choroidal neovascularization (CNV) including but not limited to CNV in the setting of wet age-related macular degeneration (wet AMD)- with Slitlamp
• · Trabeculoplasty for primary open angle glaucoma (POAG)- with Slitlamp

The 577nm laser wavelength is in the treatment of ocular pathology in the posterior segment; Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structure abnormalities of the retina and choroid including:

• · Proliferative and Severe and very severe nonproliferative diabetic retinopathy
• · Clinically Significant Macular edema
• · Choroidal neovascularization
• · Branch and central retinal vein occlusion
• · The treatment of choroidal neovascularization associated with wet age-related macular degeneration
• · Lattice degeneration
• · Retinal tears and detachments

The 670 nm laser wavelength is indicated for retinal and pan-retinal photocoagulation.

There are four selected laser wavelengths in TruScan Pro Laser console consists of integrated slitlamp for single and multi-spots laser delivery or optional LIO, Endoocular probes laser delivery units. The 532nm or 577nm laser wavelength is the primary treatment laser or configured with 670nm or 810nm secondary treatment laser to be used. Laser console is developed along with the Electronic Control system, Power Supplies, and PC Interface platform inside, and connect with 15'' LCD touch display and ophthalmic Electrical Table for use.

The TruScan Pro compatible Laser delivery units include:

TruScan module Integrated CSO SL980/SL9800 slitlamp (K992836)

Laser Indirect Ophthalmoscope using a Keeler All pupil II (K854244)

Endophotocoagulation handpieces (compatible with 510(k) cleared ophthalmic endo probes)

I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter and associated summary for the LightLas Pattern Scanning System - TruScan Pro.

This type of document primarily focuses on establishing substantial equivalence to a predicate device, outlining the device's indications for use, its technical characteristics, and the standards it complies with (e.g., electrical safety, EMC, software validation). It typically does not include detailed performance studies with acceptance criteria, sample sizes, expert involvement, or statistical analysis of device performance against a ground truth as would be found in a clinical study report for an AI/ML-based diagnostic device.

The sections on "Performance Data" (VII) discuss biocompatibility testing and compliance with electrical safety, EMC, and software verification/validation standards, rather than clinical performance metrics like sensitivity, specificity, or AUC, which would be relevant for an AI-powered diagnostic.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, expert ground truth establishment, or MRMC studies based on the provided text.

Ask a specific question about this device

Posterior Capsulotomy Pupillary Membranectomy

LPULSA SYL-9000 Ophthalmic YAG Laser

I apologize, but this document is a 510(k) clearance letter from the FDA for a medical device called the "LPULSA SYL-9000 Ophthalmic YAG Laser." This type of document confirms that the device is "substantially equivalent" to a legally marketed predicate device and can therefore be marketed.

While it specifies the "Indications for Use" (Posterior Capsulotomy and Pupillary Membranectomy), it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to the efficacy or performance studies that typically involve the questions you've asked. Such details are usually found in the 510(k) submission itself or in separate clinical study reports, which are not part of this clearance letter.

Therefore, I cannot provide the information you requested based on the provided document.

Ask a specific question about this device