(336 days)
Ophthalmology:
532nm Laser
The LightLas 532/670 system consists of a Laser Console where the Multi-Wavelength Laser is housed along with the Electronic Control system and Power Supplies and various Laser Delivery Units (LDU's). The LDU's include:
- Slitlamp Integrated into CSO model SL980.
- Slitlamp Attachment for CSO model SL990 and other Haag Streit clones.
- Slitlamp Attachment for Zeiss model SL30 Slitlamp.
- Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 180 BIO.
- Endophotocoagulation handpieces (Endoprobes).
This submission describes a medical laser system and focuses on its substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics typically associated with AI/software devices. Therefore, much of the requested information cannot be directly extracted from the provided text.
Here is an analysis based on the available information:
Key Takeaway: The submission for the LightLas Multi-Wavelength Medical Laser System (LightLas 532/670) focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving performance against specific acceptance criteria through a novel study. This means the device's performance is inferred to be similar to legally marketed devices based on shared technological characteristics and intended use, not through a separate quantitative performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Expected/Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Equivalent to predicate devices | "The intended use has not changed from the predicate devices." (Explicitly stated) |
| Technological Characteristics | Same general design, fundamental scientific technology, functional elements (treatment wavelengths, treatment power, spot size, cooling system), control systems (door interlock, safety systems, displays) as predicate devices. No new hazards introduced. | "The LightMed Multi-wavelength Medical Laser system... has the same intended use, general design and fundamental scientific technology as the predicate devices... Also the operating controls and functions are equivalent to these products. They have the same functional elements such as treatment wavelengths, treatment power, spot size and cooling system. Control systems such as the door interlock, and the safety systems and displays are constantly monitored... There are no new hazards introduced..." (Explicitly stated) |
| Clinical Effectiveness | Equivalent to previously marketed products based on specifications affecting treatment modality. | "Therefore the Clinical effectiveness of the LightLas 532/670 is equivalent to the previously marketed products as these specifications are the key factors that will affect the treatment modality." (Explicitly stated) |
| Safety Testing | Met appropriate safety standards. | "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the LightLas 532/670..." (Implied that tests were passed, but no specific criteria or results are detailed). |
| Performance Testing | Met appropriate performance standards. | "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the LightLas 532/670..." (Implied that tests were passed, but no specific criteria or results are detailed). |
| Functional Testing | Met appropriate functional standards. | "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the LightLas 532/670..." (Implied that tests were passed, but no specific criteria or results are detailed). |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This submission is for a physical medical laser device, not a software or AI device that would typically use a test set of data. The "testing" mentioned refers to engineering and safety performance of the hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. As above, this is not a data-driven AI/software device. The "ground truth" here is the established safety and effectiveness of the predicate devices in clinical practice, as recognized by the FDA through their previous clearances.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No specific test set with human adjudication is mentioned.
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 is not an AI-assisted diagnostic or therapeutic device that involves "human readers" in the sense of interpreting medical images or data. It is a direct medical laser system for ophthalmic procedures.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / Not provided. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Indirect Ground Truth: Clinical Efficacy and Safety of Predicate Devices. The "ground truth" for this substantial equivalence claim is the well-established safety and efficacy of the predicate devices. The new device is deemed equivalent because its technological characteristics and intended use are the same, implying it will perform in a clinically similar and safe manner.
8. The sample size for the training set:
- Not applicable / Not provided. There is no mention of a training set as this is not a machine learning/AI device.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
§ 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.