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The Sharplan 15F CO2 Laser System is intended for use as a heat source to activate tooth bleaching materials.

The Sharplan Model 15F CO2 Surgical Laser is a medical device which is capable of being used as a heat source for activating tooth bleaching materials. It emits a treatment laser beam at a wavelength of 10.6 um up to 15 watts in either continuous or pulse wave modes of operation.

The provided text is a 510(k) summary for the Sharplan 15F CO2 Laser System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria.

Therefore, the document does not contain any information regarding acceptance criteria, a study that proves the device meets acceptance criteria, or any of the specific details requested in your prompt (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).

The key statement that clarifies this is:
"No new intended use for a CO2 Laser was sought in this premarket notification. Therefore, no clinical data was presented."

The submission relies on the fact that the Sharplan 15F CO2 Laser System is "substantially equivalent" to its predicate devices (the Sharplan 15F CO2 Laser and the ILT CO2 Laser System) in terms of technology, intended use, and overall performance characteristics for the expanded indication of activating tooth bleaching materials. The FDA's approval is based on this finding of substantial equivalence, not on new clinical data demonstrating specific performance metrics against acceptance criteria.

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