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The SkinStation® is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris which includes pustular acne, in patients with Fitzpatrick skin types I-VI, and mild to moderate psoriasis in patients with Fitzpatrich skin types I-VI.

The Skin Station that is the subject of this 510(k) notice is the exact same device as the cleared Skin Station except for the addition of a light unit assembly specifically for the treatment of psoriasis in patients with Fitzpatrick skin types I - VI.

The provided text is a 510(k) Summary for the Radiancy SkinStation® with Modified Light Unit Assembly for Psoriasis Treatment. It describes the device, its intended use, and substantial equivalence to predicate devices, but does not contain a study or data proving the device meets specific acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided document.

The document primarily focuses on demonstrating substantial equivalence to already cleared devices, a regulatory pathway that doesn't necessarily require new clinical studies with defined acceptance criteria to be submitted or summarized in the 510(k) application itself. The statement "The new psoriasis indication for use is based upon the indications for use for two already cleared predicate pulsed light device Systems" further supports this, suggesting reliance on prior approvals rather than new performance data for this specific 510(k).

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