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The SL07 and SL08 laser slit lamps are intended for use in ophthalmology to deliver a thin, intense beam of light into the eye. Both include an adapter to deliver green laser light (532 nm) to the slit lamp by fiber optic. The user should refer to the User Manual provided with the laser for clinical use information for the laser or for additional information.

The SL07 and SL08 slit lamps are commercially available slit lamps which have been modified by Aesculap-Meditec to accommodate an adapter through which green laser light, e.g., from the EyeLite™ Laser, is delivered to the slit lamps. The laser light (532 nm) can then be directed to selected sites within the eye by an ophthalmologist.

This document describes the SL07 and SL08 Laser Slit Lamps, which are intended for use in ophthalmology to deliver a thin, intense beam of light into the eye. They also include an adapter for delivering green laser light (532 nm) via fiber optic.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission is for substantial equivalence. Therefore, there are no specific performance acceptance criteria or reported device performance metrics in the typical sense (e.g., sensitivity, specificity). Instead, the device's performance is accepted based on its similarity to legally marketed predicate devices.

The "Performance Data" section explicitly states:

"The specifications and intended uses of the SL07 and SL08 laser slit lamps are the same or very similar to those of the claimed predicate devices and other legally marketed slit lamps (as devices or as accessories to ophthalmic lasers). There are no significant differences between the SL07 and SL08 devices and claimed predicates under conditions of intended use. Because of this, performance data were not required."

The comparison table highlights key characteristics of the SL07 and SL08 in comparison to predicate devices, demonstrating their equivalence in design and function rather than quantitative performance.

2. Sample size used for the test set and the data provenance:

• Not applicable. This submission relies on substantial equivalence to predicate devices, not on a new clinical performance study requiring a test set of 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. No new ground truth for a test set was established. The basis for safety and effectiveness is the established usage and regulatory approval of predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No test set was used.

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. No MRMC study was conducted. This device is a modified slit lamp, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a physical instrument (slit lamp) with an adapter for laser delivery, which is inherently used with a human ophthalmologist. It does not involve a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate devices (Zeiss and Haag Streit Slit Lamps, Infinitech Multi-Spot Slit Lamp laser Adapter, Oculight SLx), as well as the general understanding of ophthalmic slit lamps as described in 21 CFR 886.1850 and ophthalmic lasers in 21 CFR 886.4390. The modifications made to the slit lamps (to accommodate the laser adapter) were deemed not to raise new questions of safety or effectiveness.

8. The sample size for the training set:

• Not applicable. No training set was used, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not applicable. No training set was used.

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