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The ARAMIS II Dermatological Laser system, in addition to previously cleared indications, is intended for the treatment of back acne.
The Aramis II Dermatological Laser system is intended for the treatment of back acne.

The ARAMIS II Dermatological Laser emits a beam of coherent light at 1540 nms which is delivered to the hand pieces, including a cooling hand piece, through a fiber optic.

The provided text states that no performance data was required for the Aramis II Dermatological Laser.

The device's claim of substantial equivalence to the Candela Smoothbeam is based on comparisons of specifications/characteristics and indications for use, rather than on a study demonstrating its performance against specific acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not applicable as no performance study was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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, as this is not an AI device and no clinical study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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