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The TattooStar Y is intended for use for incision, excision, ablation, vaporization of soft tissue for general dematology and the romovial of hair. benign pigmented lesion, the removal of vascular lesion and the removal of hair.

The TattooStar Y is a q-switched solid state lasers emitting wavelengths of 1064, 532 and 585 nm. It consists of a laser enclosure and optic delivery system (articulated mirror arm).

The provided 510(k) summary for the ASCLEPION LASER TECHNOLOGIES GmbH TattooStar Y does not include any acceptance criteria or studies demonstrating device performance.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device, the Medlite C6. This means the manufacturer is asserting that their device is as safe and effective as a device already legally marketed, without needing to conduct new performance studies.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." Therefore, there are no acceptance criteria or stated performance metrics provided in this 510(k) summary. The submission's argument for market clearance is based on substantial equivalence, not on specific performance data against acceptance criteria.

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

Not applicable. No performance studies were conducted as part of this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No performance studies were conducted.

4. Adjudication method for the test set

Not applicable. No performance studies were 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 for medical procedures, not an AI-assisted diagnostic tool. No MRMC studies were mentioned or would typically be relevant for this type of device.

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

Not applicable. This device is a laser for medical procedures, not an algorithm.

7. The type of ground truth used

Not applicable. No performance studies were conducted.

8. The sample size for the training set

Not applicable. No performance studies were conducted, and this is not an AI/machine learning device that would typically have a training set.

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

Not applicable. No performance studies were conducted, and this is not an AI/machine learning device.

Conclusion from the 510(k) Summary:

The device (TattooStar Y) achieved market clearance by demonstrating substantial equivalence to a legally marketed predicate device (Medlite C6). This means the FDA concluded that the TattooStar Y has the "same intended use" and "same technological characteristics" as the predicate, or if there are differences, those differences "do not raise different questions of safety and effectiveness." The manufacturer did not provide new performance data or clinical studies in this submission because the substantial equivalence pathway allows for this, particularly when the technology is well-established.

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