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1. Klarity SRS Baseplate: The device is indicated to position and/or immobilize adult and pediatric patients undergoing photon and electron radiation therapy of the head, brain, and neck. The device provides noninvasive immobilization by supporting the patient and enabling attachment of a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning, repositioning and immobilization. The Klarity SRS Basplate allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.
2. Klarity Promise Baseplate: The device is indicated to position and or immobilize adult and pediativ undergoing proton radiation therapy of the head, brain, and neck. The device provides noninvasive immobilization by supporting the pabling attachment of a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning and immobilization. The Klarity Promise Baseplate allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

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The provided text is an FDA 510(k) clearance letter for the Klarity SRS Baseplate and Klarity Promise Baseplate. It grants clearance for these devices but does not contain information about acceptance criteria or specific study results proving the device meets them.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the clearance is based on a determination of substantial equivalence to a predicate device, not on clinical performance data demonstrating specific acceptance criteria.

The information you are requesting, such as performance metrics, sample sizes, expert qualifications, and ground truth methodologies, would typically be found in the 510(k) submission itself or related study reports, which are not part of this FDA clearance letter.

Therefore, I cannot provide the requested information based on the input text.

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