(120 days)
The SOLUTIS Laser is indicated for use in: Selective Laser Trabeculoplasty (SLT)
SOLUTIS is a Q-switched, frequency doubled Nd:YAG laser providing a wavelength of 532 nm for use in Sclective Laser Trabeculoplasty. The treatment beam delivers a 4ns, 0.2-2 mJ adjustable single pulse of energy. The aiming beam and treatment beams are coaxial with each other and focused by the slit lamp objective to a 400um spot at the focal point of the lens. The SOLUTIS is compatible with Haag Streit 900 BM and Haag Streit 900 BQ slit lamps only.
The provided text is a 510(k) Summary for the Quantel Medical SOLUTIS, an ophthalmic laser system. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving acceptance criteria for device performance in a clinical or diagnostic context, especially not one that would involve AI, human readers, ground truth establishment, or sample sizes as typically inquired about for AI/ML-based medical devices.
Instead, the performance data section states:
"Laboratory testing was conducted to validate and verify that the SOLUTIS Laser met all design specifications and was substantially equivalent to the predicate device."
This indicates that the "acceptance criteria" were related to engineering design specifications and technical parameters to show equivalence to existing devices in a laboratory setting, rather than clinical efficacy or diagnostic accuracy.
Therefore, most of the requested information regarding acceptance criteria and a study proving device meets them (especially those pertaining to AI, human reader performance, ground truth, and sample sizes of a test or training set) cannot be extracted from this document as it does not contain details about such a study.
Here's what can be gathered, with caveats:
1. A table of acceptance criteria and the reported device performance
The document states: "Laboratory testing was conducted to validate and verify that the SOLUTIS Laser met all design specifications and was substantially equivalent to the predicate device."
It does not provide a specific table of acceptance criteria (e.g., specific energy output ranges, spot size tolerances) nor the numerical reported performance for each criterion. The general acceptance criterion was likely meeting predefined design specifications and demonstrating performance comparable to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The "test set" was laboratory testing, not a clinical study with patient 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)
Not applicable. Ground truth as typically understood in AI/ML medical devices (e.g., expert consensus on images, pathology results) is not relevant for this type of laboratory performance testing. "Ground truth" would likely refer to calibrated measurement equipment in the lab.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to expert review of clinical cases.
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. This device is an ophthalmic laser for treatment (Selective Laser Trabeculoplasty), not a diagnostic device involving AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical laser device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not specified, but for laboratory testing, ground truth would be established by calibrated measurement tools and engineering standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.