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Coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.

The LS Family of CO2 Lasers are microprocessor-controlled CO2 laser systems using a sealed CO2 laser tube providing either 15 watts maximum power (LS-15 ) or 25 watts maximum power (LS-25). The system incorporates a CO2 laser tube within the main cabinet, an articulated arm beam delivery system and attachable laser accessories. The unit is activated for laser emission by a footswitch.

The manufacturer did not provide specific acceptance criteria or a study that rigorously proves the device meets such criteria. Instead, the submission focuses on establishing substantial equivalence to predicate devices based on the device's functional description and intended use.

Here's a breakdown of the requested information based on the provided document:

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

   Acceptance Criteria	Reported Device Performance
   Not explicitly stated in the provided document. The submission focuses on substantial equivalence to predicate devices rather than specific quantitative performance criteria.	The LS Family of CO2 Lasers are microprocessor-controlled CO2 laser systems using a sealed CO2 laser tube providing either 15 watts maximum power (LS-15) or 25 watts maximum power (LS-25).

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

   • Sample Size for Test Set: Not applicable. No clinical or performance test data is mentioned for a test set.
   • Data Provenance: Not applicable. No performance data or studies were conducted for this submission.

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 ground truth was established as no clinical or performance data was provided.

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

   • Not applicable. No test set or adjudication process 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

   • No. This is a medical device (CO2 laser system), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable. No such study was conducted or reported.

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

   • No. This is a medical device (CO2 laser system), not an algorithm. Therefore, no standalone algorithm performance study was conducted.

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

   • Not applicable. No ground truth was established, as no clinical or performance studies were conducted to assess the device's accuracy against a known standard.

8. The sample size for the training set

   • Not applicable. No training set was used, as no machine learning or AI algorithm development was involved.

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

   • Not applicable. No training set or ground truth for a training set was established.

Summary of the Study (or lack thereof):

The provided document explicitly states under "Performance Data" and "Results of Clinical Study" that there is "None." The conclusion is that "The LS Family of CO2 Lasers are substantially equivalent to other existing CO2 Laser System in commercial distribution for use in Dermatology and Plastic Surgery." This implies that the device's safety and effectiveness were established through comparison to legally marketed predicate devices (UltraPulse CO2 Surgical Laser K030147 and Luxar LX-20SP Surgical Laser K953074), rather than through new clinical performance studies or specific acceptance criteria tests unique to this device. The FDA's letter confirms a "substantial equivalence" determination based on the information provided in the 510(k) premarket notification.

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