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Diamond Air+ is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Diamond Air+, Model: UI04A, UI04B, UI04C, UI04M, UI04G, UI04W is a light-based device for long-term hair removal. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology can achieve long-term hair removal results at a fraction of the energy level used in other light -based hair removal equipment.

The size of the device is about 6038169.86mm (W x D x H). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.

The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the Diamond Air+ is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

I am unable to provide information about the acceptance criteria and study that proves the device meets the acceptance criteria for the Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) based on the provided document.

The document primarily focuses on the FDA 510(k) clearance process, stating that the device is "substantially equivalent" to a legally marketed predicate device. While it mentions the device's intended use for hair removal and permanent reduction in hair regrowth, and touches upon parameters like wavelength and fluence, it does not contain a study that demonstrates the device's performance against specific acceptance criteria.

The "Conclusion" section within the document states: "The subject device 'Diamond Air+, Model: UI04A, UI04B, UI04C, UI04M, UI04G, UI04W' is substantial equivalent to the predicate device." This indicates that the clearance was based on demonstrating equivalence to an already cleared device, rather than providing a detailed study of the subject device's performance against pre-defined acceptance criteria.

Therefore, I cannot extract the information required for the table or the other requested points (sample size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, type of ground truth, training set details) from this document.

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