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STARLIGHT® is a light-based system intended for the removal of unwanted hair (permanent hair reduction*) and the treatment of benign cutaneous, vascular and pigmentary lesions in skin phototypes I to V of the Fitzpatrick Table.
*Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

STARLIGHT® is a light-based system that delivers Intense Pulsed Light in the region of 530 to 1200 nanometers of the Electromagnetic Spectrum. The system has been designed to be compact and self-contained, comprising:
-A central module
-An LCD and soft-touch keyboard interface
-Two application handpieces housing a flash lamp, a light conducting glass w/filter and two shooting buttons
-An integrated Hydraulic Cooling System
The system's electronics and user interface are controlled by a microcontroller.

This document is a 510(k) summary for the STARLIGHT® Pulsed Light Device. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study performing acceptance criteria. Therefore, the requested information cannot be fully provided from the text and describes the device's technical characteristics, and intended use as well as declares substantial equivalence to a predicate device, but does not present a study with acceptance criteria and device performance results as would be found in a clinical trial.

However, based on the provided text, here's what can be extracted and inferred regarding 'acceptance criteria' in the context of a 510(k) submission:

1. A table of acceptance criteria and the reported device performance

The document does not contain a table of explicit acceptance criteria with numerical performance metrics. In a 510(k) submission for substantial equivalence, the "acceptance criteria" are typically met by demonstrating that the new device has "technological characteristics, performance, intended use, indications, operation and application" that are similar to a legally marketed predicate device, and thus no new questions on safety and effectiveness are raised.

The key "performance" reported is related to its similarity to the predicate:

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

The document does not describe a "test set" in the context of a performance study with a specific sample size. As a 510(k) submission, it likely relies on existing data or literature for the predicate device, or internal bench testing, but these details are not provided in this summary.

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

This information is not applicable to a 510(k) summary focused on substantial equivalence. There is no mention of "ground truth" or experts for a specific test set.

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

This information is not applicable to an equivalence submission and is not provided.

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

This is not an AI device, and no MRMC study or AI-related effectiveness study is mentioned or implied.

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

This is not an AI device, and no standalone algorithm performance study is mentioned.

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

This is not applicable as no clinical study with "ground truth" is described in this summary.

8. The sample size for the training set

The document does not mention any "training set" as it is not a machine learning or AI device that would typically have one.

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

Not applicable, as there is no training set mentioned.

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