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For use in dermatology for the incision, excision, ablation, vaporization and hemostasis of soft tissue.

The Medlite\Erbium Laser is an erbium laser producing laser emissions at 2.94 $\mu$ . The laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 5 pulses per second and a pulse energy of 2 Joules, the average power from the laser is 10 watts.

This 510(k) summary for the K961748 Medlite Erbium Laser System does not contain the detailed acceptance criteria or a study proving the device meets those criteria, as it explicitly states:

• Nonclinical Performance Data: none
• Clinical Performance Data: none

Therefore, I cannot provide the information requested in your prompt based solely on the provided K961748 document. The device was deemed substantially equivalent to a predicate device (SEO Medical TriLase 2940 Erbium Laser System; K954013) without specific performance studies detailed in this summary.

Here's a breakdown of why each requested item cannot be answered:

1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are reported.
2. Sample sized used for the test set and the data provenance: No test set data or provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment or experts are mentioned.
4. Adjudication method for the test set: No test set or adjudication method is mentioned.
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 is a laser system, not an AI-assisted diagnostic device, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a laser system, not an algorithm, and no such performance study is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study with ground truth is mentioned.
8. The sample size for the training set: Not applicable, as no algorithm training or training set is mentioned.
9. How the ground truth for the training set was established: Not applicable, as no algorithm training or training set is mentioned.

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