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The DermaStar Er: YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

The DermaStar Er: YAG Laser System is an Erbium:YAG laser with a wavelength of 2.94um. It consists a laser enclosure and fiber optic delivery system (including hand piece).

The provided text is a 510(k) summary for the ASCLEPION-MEDITEC AG DermaStar Er:YAG Laser System. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting novel performance data from a clinical study with detailed acceptance criteria and expert reviews.

Here's a breakdown based on the request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance metrics in a table. The primary acceptance criterion for a 510(k) is substantial equivalence to a predicate device.
• Reported Device Performance: "None" is explicitly stated. The submission relies on the specifications and intended uses being "the same or very similar" to legally marketed predicate devices.

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

• Sample size: Not applicable. No performance data or test set was used for this submission. The determination of substantial equivalence was based on a comparison of device specifications and intended uses.
• Data provenance: Not applicable.

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 was utilized.

4. Adjudication method for the test set:

• Not applicable. No test set was utilized.

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, and no MRMC study was performed.

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. No ground truth was established as no performance study was conducted. The basis for clearance was a comparison of features and intended use with predicate devices already cleared by the FDA.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device. The determination was based on existing predicate device specifications.

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

• Not applicable. No training set was used.

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