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The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

IBA PROTON THERAPY SYSTEM - PROTEUS 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

The provided document is an FDA 510(k) clearance letter for the "IBA Proton Therapy System - Proteus 235." This letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment. It is a regulatory approval document, not a detailed technical report of the device's validation.

To answer your request, a detailed performance study report (often submitted as part of the 510(k) application but not part of this public clearance letter) would be required. The information you are seeking is typically found in the clinical or technical validation sections of the 510(k) submission, which are not included in this FDA correspondence.

Therefore, I cannot extract the requested information from the provided text.

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