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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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Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

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 .
• iridotomy, iridectomy and trabeculoplasty in angle closure and open angle . glaucoma.

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.

{
"1. A table of acceptance criteria and the reported device performance": "The provided text does not contain specific acceptance criteria or detailed device performance metrics in a tabular format. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with quantified performance measures against pre-defined criteria.",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document states that "All necessary bench testing was conducted" but does not specify sample sizes for any test set or provide details on data provenance (country of origin, retrospective/prospective nature). The focus is on bench testing to show substantial equivalence, not clinical study data.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "No information about experts, ground truth establishment, or their qualifications is provided in the document. This is likely due to the nature of the submission being for a medical device (laser system) where substantial equivalence is primarily based on technical specifications and safety rather than a diagnostic algorithm's performance against human experts.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "No information regarding an adjudication method is present, as there is no mention of a test set requiring such a process.",
"5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The device is a photocoagulator, a treatment laser, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this device.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The device described is a photocoagulator (a laser instrument) and not an algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not conducted.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "There is no mention of ground truth in the context of diagnostic accuracy, as the device is a treatment laser. The testing described is bench testing to determine substantial equivalence based on function, intended use, and performance relative to a predicate device, not diagnostic accuracy against a ground truth standard.",
"8. The sample size for the training set": "The document does not refer to a 'training set', as the submission is for a medical device (laser system) and not an AI/ML algorithm requiring a training phase.",
"9. How the ground truth for the training set was established": "Not applicable, as there is no training set mentioned or a requirement for ground truth establishment for a training set in this context."
}

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