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The PASCAL Streamline Photocoagulator indications for use are the following: Intended for use in the treatment of ocular pathology in the posterior segment. Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy - macular edema - choroidal neovascularization - branch and central retinal vein occlusion - age-related macular degeneration - lattice degeneration - retinal tears and detachments Intended for use in the treatment of ocular pathology in the anterior segment including: - iridotomy - trabeculoplasty

The PASCAL Streamline Photocoagulator is an integrated system comprising of solid state aiming and treatment lasers, control electronics, graphical user interface, slit lamp and table. It is intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

The PASCAL® Streamline™ Photocoagulator is designed for treating ocular pathology in both the posterior and anterior segments of the eye. Its indications for use include retinal photocoagulation, panretinal photocoagulation, focal photocoagulation, and grid photocoagulation for various vascular and structural abnormalities of the retina and choroid, such as proliferative and nonproliferative diabetic retinopathy, macular edema, choroidal neovascularization, branch and central retinal vein occlusion, age-related macular degeneration, lattice degeneration, and retinal tears and detachments. Additionally, it is indicated for use in the anterior segment for iridotomy and trabeculoplasty.

The document provided (K100019) is a 510(k) summary for the PASCAL® Streamline™ Photocoagulator, submitted by OptiMedica Corporation. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, the PASCAL Streamline Photocoagulator (K092621), and not to conduct a study proving the device meets specific acceptance criteria with performance metrics.

Therefore, the provided text does not contain information regarding
acceptance criteria, device performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case (MRMC) studies, standalone performance studies, types of ground truth, or details about the training set used in the development of the device.

Instead, the document focuses on demonstrating substantial equivalence based on function, intended use, and technological characteristics without raising new issues of safety or efficacy compared to the predicate device.

The document states:

• "All necessary bench testing was conducted on the modified PASCAL Streamline Photocoagulator to support a determination of substantial equivalence to the predicate device."

This indicates that internal bench testing was performed to justify the claim of substantial equivalence, but the specifics of these tests, including acceptance criteria and how they directly quantify "device performance" in the context of clinical outcomes or diagnostic accuracy, are not detailed.

Consequently, I cannot fill out the requested table or provide specific answers to questions 1-9 based on the provided text. The information needed to address those points, such as clinical study results, performance metrics like sensitivity/specificity, or details about AI algorithms and their validation studies, is not present in this 510(k) summary. This document is a regulatory submission for market clearance, not a report on a clinical trial or performance study against specific acceptance criteria.

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