(253 days)
VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye including trabeculoplasty and iridotomy.
VISULAS green is an ophthalmic laser with a 532 nm wavelength used for standard photocoagulation treatments of ocular tissue. VISULAS green is operated in single-spot mode or in multi-spot mode.
VISULAS green consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as laser endoprobes, or the SL cam 5.0.
The provided document is a 510(k) premarket notification for the VISULAS green ophthalmic laser system. It describes the device, its intended use, and a comparison to a predicate device (VISULAS 532s Laser System).
It is crucial to understand that this document does not describe a study involving an AI/machine learning device or a comparative effectiveness study with human readers assisting AI. This 510(k) submission is for a conventional medical device (a laser system) and focuses on demonstrating substantial equivalence to a legally marketed predicate device based on technological characteristics, safety standards, and intended use.
Therefore, many of the requested points regarding acceptance criteria and studies for AI/ML performance, such as sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, and training set details, are not applicable to this document as it does not concern an AI/ML device.
However, I can extract information related to the acceptance criteria and performance data for this specific medical device as presented in the document:
1. A table of acceptance criteria and the reported device performance
Based on the document, the "acceptance criteria" are not framed as quantitative performance metrics for a diagnostic or AI device. Instead, they are compliance with established safety and performance standards for a laser system and demonstration of substantial equivalence to a predicate device.
| Acceptance Criterion (Compliance with Standards/Equivalence to Predicate) | Reported Device Performance/Compliance |
|---|---|
| Biocompatibility | Materials and manufacturing are identical to the predicate device and currently marketed devices. No new biocompatibility testing needed. |
| Laser Safety | Complies with: |
- IEC 60825-1:2007
- IEC 60601-2-22:2012 |
| Electrical Safety | Complies with: - ANSI/AAMI ES60601-1:2005/(R)2012
- IEC 60601-1-2:2014
- IEC 62133: 2012 |
| Electromagnetic Compatibility (EMC) | Complies with: - IEC 60601-1-2:2014 |
| Software Verification & Validation | Software is considered "Major" level of concern. Verification and validation testing conducted as per FDA guidance. Documentation provided. Device works as designed. |
| Technological Equivalence to Predicate (VISULAS 532s) | Same laser type (solid state, frequency-doubled), wavelength (532 nm), power range (50-1500 mW), pulse length (10-2500 ms and cw), repeat mode, laser spot size settings (50-1000 µm), aiming beam (620-650 nm), types of laser applicators, and multi-spot treatment mode. |
| Indications for Use Equivalence to Predicate | VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye, including trabeculoplasty and iridotomy. This is within the same intended use as the predicate and does not raise different questions of safety and effectiveness. |
| Principle of Operation Equivalence to Predicate | Both devices operate on the principle of photocoagulation (continuous wave operation where thermal energy from laser absorption causes coagulation). |
2. Sample size used for the test set and the data provenance
- Not applicable. This submission is for a conventional laser device, not an AI/ML diagnostic. Performance was demonstrated through compliance with recognized standards and comparison to a predicate, not through a clinical test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No test set requiring expert ground truth for an AI/ML diagnostic was performed or described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication was performed or 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
- No. An MRMC study was not done because this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm-only device. It is a physical laser system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. As a conventional laser device, the "ground truth" related to its performance is established by its compliance with industry safety standards (e.g., laser power output accuracy, electrical safety, EMC) and demonstration that its operating principles and technological characteristics are equivalent to a well-established predicate device. There is no diagnostic "ground truth" for patient data in this context.
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a training set.
In summary, the provided document is a 510(k) premarket notification for a Class II ophthalmic laser device. The "acceptance criteria" and "study" described pertain to demonstrating safety, functional performance, and substantial equivalence to a predicate device, primarily through compliance with established industry standards (e.g., IEC, ANSI) and direct comparison of technical specifications. It does not involve AI/ML technology, and therefore, many of the questions related to AI device performance evaluation are not relevant to this submission.
§ 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.