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The IPL Therapy Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in the hair removal at a wavelength ranging from 640nm-1200nm.

The IPL Therapy Systems (ST-AI) is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 640nm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin. IPL Therapy system is different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores. Based on this, the IPL Therapy Systems (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in the hair removal.

This document describes an "IPL Therapy System" (ST-AI) and its substantial equivalence to predicate devices, focusing on its use for hair removal. However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria, nor does it include performance data, sample sizes, expert qualifications, or details about ground truth.

The document is a 510(k) summary for a medical device and primarily focuses on:

• Identification of the device and sponsor.
• Device description: An intense pulsed light (IPL) system working on selective photothermolysis for hair removal.
• Intended use: Surgical, aesthetic, and cosmetic applications in hair removal.
• Compliance with standards: IEC 60601-1 and IEC 60601-1-2.
• Substantial Equivalence (SE) determination: The FDA determined the device is substantially equivalent to existing legally marketed devices (K091664 and K083915). This determination is based on the claim that the device is safe and effective because it is substantially equivalent to predicates, not through direct performance studies presented in this summary.

Therefore, I cannot fulfill your request for: Acceptance criteria table, reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set size, or how ground truth for the training set was established.

This information would typically be found in detailed clinical or performance studies, which are not part of the provided 510(k) summary. The summary only attests that the device is designed, tested, and will be manufactured in accordance with specified safety standards and that it's substantially equivalent to predicate devices for its intended hair removal use.

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