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The MultiStar Laser System is intended for the coagulation, ablation, vaporization, incision, excision, cutting of soft tissue in plastic surgery, general surgery, oral surgery, ENT, gynecology and dermatology.

The MultiStar Laser System is a CO2 - Gas Laser. It emits a beam of coherent light at the wavelength of 10600 nm with a maximum power of 30 Watt

The provided 510(k) summary does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it indicates:

1. A table of acceptance criteria and the reported device performance:
Not applicable. The document states "Nonclinical Performance Data: None" and "Clinical Performance Data: None."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable. No performance or clinical data is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. No performance or clinical data is provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No performance or clinical data is 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:
Not applicable. This device is a laser system, not an AI-assisted diagnostic tool. No MRMC study was mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No performance or clinical data is provided.

8. The sample size for the training set:
Not applicable. This device is a laser system, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established:
Not applicable. This device is a laser system, not a machine learning algorithm requiring a training set.

Summary from the document:

The 510(k) summary for the MultiStar Laser System states that it is "substantially equivalent to the Multipulse Laser System, with the same principles of operation, the same wavelength and essentially the same power range as the predicate device for the same indications for uses." The conclusion is that "The MultiStar Laser System is another safe and effective device for coagulation, ablation, vaporization, incision, excision, cutting of soft tissue..." This submission relies on substantial equivalence to a predicate device rather than presenting new performance data.

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