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The SmoothLASE TM Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The SmoothLASE TM Alexandrite Laser System is intended for use only by qualified physicians trained in the safe operation of the system.

The SmoothLASE TM Alexandrite Laser System is a medical device which is capable of emitting an invisible treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. In addition to the standard pulse width of nominally 1 Msec at 1Hz, the SmoothLASE TM Alexandrite Laser System will operate up to 3 Hz. Additionally, a single pulse is modulated to provide 6 x 1 Msec pulses at 1.3 Hz.

The provided text is a 510(k) summary and FDA clearance letter for the SmoothLASE™ Alexandrite Laser System. It focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria through performance metrics. Therefore, most of the requested information regarding acceptance criteria, study design, statistical analysis, and expert input is not present in the provided document.

However, I can extract the information that is available:

1. A table of acceptance criteria and the reported device performance

This information is not present in the document. The document primarily focuses on regulatory classification, safety features based on standards, and substantial equivalence to predicate devices. There are no specific performance metrics or acceptance criteria reported for device efficacy (e.g., hair removal effectiveness).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not present as no specific clinical study data (test set) is provided or referenced in detail for performance evaluation.

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)

This information is not present as there is no mention of a test set requiring expert ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not present.

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

This is not applicable as the device is a laser system for hair removal, not an AI-assisted diagnostic or interpretive tool. There are no human "readers" in the context of this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not present as no specific study data or ground truth establishment is detailed. The basis for safety and effectiveness is stated as substantial equivalence to predicate devices.

8. The sample size for the training set

This information is not present as no training set for an algorithm is mentioned or relevant to this device.

9. How the ground truth for the training set was established

This information is not present.

Summary of available information related to safety and effectiveness:

While the document does not contain the detailed study information requested, it does state:

• Safety Features: "The safety features of the device have been designed in accordance with relevant standards such as BS EN 60825-1 (Safety of Laser Product) and BS EN 6061-2-22 (Medical Electrical Equipment Safety). The labeling complies with 21 CFR subchapter J for a Class IV laser product." This indicates adherence to established safety standards, which can be seen as meeting "acceptance criteria" for safety.
• Predicate Devices: The device is deemed "substantially equivalent" to the Cynosure PhotoGenica LPIR (K971737) and the Lambda LaseAway Alexandrite Laser distributed by Silver Creek Surgical (K982316). The FDA's finding of substantial equivalence implies that the device is considered as safe and effective as these previously cleared devices, which have presumably met their own acceptance criteria.
• Conclusion: "The SmoothLASE TM Alexandrite Laser System is safe and effective for the intended purpose of removal of unwanted body hair on adults 18 years of age or older." This conclusion is based on the substantial equivalence review.

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