(30 days)
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."
}
§ 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.