(76 days)
The Pascal Photocoagulator indications for use are the following:
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 laser photocoagulator is an integrated system comprising 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.
This document describes a 510(k) premarket notification for the Pascal™ Photocoagulator. A 510(k) submission seeks to demonstrate "substantial equivalence" to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth for a study proving device performance is not applicable in this context.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This 510(k) submission does not establish or report against specific performance acceptance criteria from a clinical trial in the way a PMA submission might. Instead, it seeks to demonstrate substantial equivalence to previously cleared predicate devices. The "performance" demonstrated is that the device has "the same or similar technological characteristics" as the predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No clinical "test set" and corresponding sample size are mentioned for proving specific performance criteria of the Pascal™ Photocoagulator in this document. The submission relies on non-clinical tests and comparison to predicates.
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)
- Not Applicable. No ground truth establishment by experts for a clinical study is described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a clinical test set is described.
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
- Not Applicable. The Pascal™ Photocoagulator is a laser surgical instrument, not an AI-assisted diagnostic or assistive device that would typically involve a multi-reader multi-case study for human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical device (laser photocoagulator) and not an AI algorithm. Therefore, a "standalone algorithm performance" study is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. As no clinical study to prove novel performance criteria is detailed, no specific ground truth for such a study is mentioned. The "truth" in a 510(k) context is that the device is substantially equivalent to legally marketed predicate devices, based on technological characteristics and intended use.
8. The sample size for the training set
- Not Applicable. This document does not describe a machine learning algorithm or a "training set."
9. How the ground truth for the training set was established
- Not Applicable. Not applicable as there is no training set mentioned.
Summary of what is available from the document:
- Device Name: Pascal™ Photocoagulator
- Intended Use: Treatment of ocular pathology in both the posterior and anterior segments (detailed list provided).
- Basis for Clearance: Substantial equivalence to predicate devices (Lumenis Novus Varia, Laserex LP1 532, Iridex Oculight SL/SLx, Iridex Medical Oculight GL, Infinitech Slit Lamp Laser Adapter).
- Technological Characteristics Compared: Treatment wavelengths, laser active medium, pumping system, aiming beam, mode of operation, exposure duration, power, treatment intervals, spot size, semi-automatic repeat mode, controls and displays, laser energy delivery control (foot switch), and slit lamp delivery.
- Nonclinical Tests: Performance test results, system and software hazard analysis information, and system and software verification and validation information were submitted. These are non-clinical and relate to safety and basic functional performance, not clinical efficacy or specific acceptance criteria met in a patient study.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.