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The TattooStar Effect Combo is indicated for incision, ablation and vaporization of soft tissue in general dermatology and the removal of tattoos, pigmented lesions and skin resurfacing procedures. Depending on the wavelength selected, the indications are as follows:

Wavelength 1064 nm: Removal of black and blue tattoo color, Skin resurfacing
Wavelength 532 nm: Removal of pigmented lesions (including but not limited to lentigo benigna, hyperpigmented bum and boil scar, naevus Ota / Ito, freckles, Becker naevi, Cafe-au-lait spots), Removal of red tattoo color
Wavelength 585 nm: Removal of sky blue tattoo color
Wavelength 694nm: Removal of pigmented lesions, Removal of black, blue and green tattoo color

The TattooStar Effect Combo is a combination of a Nd:YAG laser and a Ruby laser. Both lasers are pulsed q-switched lasers, the Nd:YAG can optionally emit millisecond pulses in the Free-running mode. The Nd:YAG laser emits wavelengths of 1064nm and 532nm. The beam can be converted to 585nm by means of an optional dye handpiece. The Ruby laser emits 694 nm radiation.

The provided document is a 510(k) summary for the TattooStar Effect Combo, a laser surgical instrument. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting detailed acceptance criteria and performance data from a clinical or non-clinical study for a novel device.

Therefore, many of the requested sections regarding acceptance criteria and study details cannot be fully extracted from this document as they are not present. This type of submission relies on showing that the new device is as safe and effective as a predicate device, often without new clinical studies if the technology and indications are sufficiently similar.

Here's the breakdown of what can be gathered:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense for a new clinical study. Instead, it compares the technical specifications and indications of the TattooStar Effect Combo to its predicate devices (TattooStar R and TattooStar Effect Y) to demonstrate substantial equivalence. The "performance" is implied by matching or being within acceptable ranges of the predicate device's specifications.

Note on "Acceptance Criteria": The implied acceptance criteria for a 510(k) submission primarily revolve around demonstrating "substantial equivalence" to a predicate device. This means showing that the new device has the same intended use, and either the same technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness. The table above shows the comparison of technological characteristics.

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

The document explicitly states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

This means there was no specific test set or clinical study conducted for this 510(k) submission to assess the device's performance in a traditional sense. The device's safety and effectiveness are established by its substantial equivalence to previously cleared devices.

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

Not applicable, as no dedicated test set or clinical study was presented.

4. Adjudication method for the test set

Not applicable, as no dedicated test set or clinical study was presented.

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-powered diagnostic tool. No MRMC study was mentioned.

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

Not applicable, as this is a medical device (laser) and not an algorithm requiring standalone performance evaluation in that context.

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

Not applicable, as no dedicated test set or clinical study was presented that would require establishing ground truth. The basis for clearance is substantial equivalence to predicate devices, whose ground truth for effectiveness would have been established historically.

8. The sample size for the training set

Not applicable, as this is a medical device (laser) and not an algorithm that typically uses a "training set."

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

Not applicable, as no training set was used.

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