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The Lite Touch Erbium Laser Treatment System is intended for the coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, including aesthetic surgery and resurfacing.

The Lite Touch Erbium Laser is an Erbium:YAG laser which emits its energy at 2.94um.

This document, K974460, is a 510(k) summary for the Lite Touch Erbium Laser Treatment System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria.

Therefore, the following information is largely not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided because no performance data was deemed required for this 510(k) submission. The submission states, "None. The specifications and intended uses of the Lite Touch Erbium Laser Treatment System are the same or very similar (substantially equivalent) to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use. Because of this, performance data were not required."

2. Sample size used for the test set and the data provenance: Not applicable, as no performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study was conducted.

4. Adjudication method for the test set: Not applicable, as no performance study was conducted.

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. This device is a laser system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser system, not an algorithm.

7. The type of ground truth used: Not applicable, as no performance study was conducted.

8. The sample size for the training set: Not applicable, as no machine learning algorithm or training set is mentioned for this device.

9. How the ground truth for the training set was established: Not applicable, as no machine learning algorithm or training set is mentioned for this device.

Key takeaway from the document:

The regulatory strategy for the Lite Touch Erbium Laser Treatment System was to demonstrate substantial equivalence to already legally marketed predicate devices (Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser, and Continuum Biomedical, Inc., Multilite Erbium Laser and CB Erbium 2.94™ Systems). This approach meant that a new de novo performance study with specific acceptance criteria was not required by the FDA. The submission focused on comparing the specifications and intended uses of the new device to those of the predicate devices.

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