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The SMAXEL (formally the MX-7000 MICROXEL) Fractional C02 Laser System is indicated for use in non-fractional mode is incision, excision, ablation, vaporization of human soft tissue. Intended for use in Dermatology, Plastic and General Surgery, Gynecology, Neurosurgery, and Podiatry.

When used in fractional mode, the SMAXEL Fractional C02 Laser System indications for use in ablative skin resurfacing, wrinkles, fine lines, rhylides, and furrows in Dermatology, Plastic and General Surgerv,

SMAXEL CO2 Surgical Laser System

This is a 510(k) clearance letter for the SMAXEL CO2 Surgical Laser System. It is an administrative document and does not contain the specific technical study details needed to answer your questions regarding acceptance criteria and performance data.

The letter confirms that the FDA has reviewed the device and determined it is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their 510(k) submission, which would include performance data, but that data is not part of this public letter.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance: This letter does not specify any performance criteria or reported results.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not available in this document.
4. Adjudication method: Not available in this document.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not available in this document. This device is a surgical laser, not an AI diagnostic tool, so such a study would likely not be relevant.
6. Standalone performance: Not applicable in the context of a surgical laser as described here.
7. Type of ground truth used: Not applicable or available.
8. Training set sample size: Not applicable or available.
9. How the ground truth for the training set was established: Not applicable or available.

The document only states the device's indications for use and confirms its regulatory status. To find the detailed clinical and performance data, one would typically need to review the full 510(k) submission, which is generally not publicly available beyond a summary.

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