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The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. It is intended for use in:

• Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction
• Treatment of mild to moderate inflammatory acne (acne vulgaris) .
• Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and cafè-au-lait

The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 mm to 1200 mm. The Axion Intense Fullood Eight Oyel Cyell is based on a quick power discharge of Capacitors in a Xenon ramp, mountou on a hanspires include the charge intense Fulsed Eight. The four philopal pairol panel, and a handpiece with exchangeable lamp box

The provided text is a 510(k) summary for the AXIOM Intense Pulsed Light System. It states explicitly that no performance data was required or submitted for this Class II device by the Food and Drug Administration (Office of Device Evaluation).

Therefore, the following information cannot be extracted from the document:

• A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data is presented.
• Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
• Adjudication method for the test set: No adjudication method is mentioned.
• 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 MRMC study was conducted.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an Intense Pulsed Light System, not an algorithm, so this is not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is mentioned.
• The sample size for the training set: No training set is mentioned.
• How the ground truth for the training set was established: No ground truth for a training set is mentioned.

The document focuses on demonstrating substantial equivalence to predicate devices (Flash1, Med FlashII, SpaTouch, IPL Quantum SR, Clareon Pulsed Light System, Photosilk Plus) based on shared indications for use and similar technological characteristics, controls, displays, and light sources. The FDA concluded that the device is substantially equivalent, allowing it to be marketed.

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