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The Cynosure Accolade Laser is indicated for tattoo and benign cutaneous pigmented lesions removal.

The Accolade Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench.

The provided document is a 510(k) summary for the Cynosure Accolade Laser, which is a medical laser system. The document explicitly states:

Nonclinical Performance Data: None
Clinical Performance Data: None

This means that no studies or data were provided to demonstrate the device meets any acceptance criteria for performance, whether nonclinical or clinical. The FDA approval was based on substantial equivalence to a predicate device (Cynosure PhotoGenica HT10 Laser) in terms of treatment wavelength, pulse duration, pulse energy, and biological effects, not on new performance data from the Accolade Laser itself.

Therefore, I cannot provide the requested information. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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