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The Small Field Applicator is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

Small Field Applicator is an optional accessory to the proton beam therapy system which can be added to the nozzle configuration of the cleared PROBEAT-V system to make the lateral penumbra sharp, as needed. The Small Field Applicator may be used in place of the optional removable Applicator having an aperture (collimator) that has been cleared as part of the PROBEAT-V system.

The Small Field Applicator is composed of a cylinder part with touch sensors, a 4-legged table, and a plate part. The Small Field Applicator is inserted at the end of the nozzle to obtain a sharp lateral penumbra in the lateral dose distribution, and it can reduce the dose to the surrounding normal tissue than the case in which the Small Field Applicator is not used.

The provided FDA 510(k) summary for the "Small Field Applicator" does not contain the information requested regarding acceptance criteria, study details, and ground truth establishment typically found in AI/ML device submissions.

This document describes a physical accessory for a radiation therapy system, not a software-based AI/ML device that requires extensive performance studies against clinical ground truth. The "Performance Data" section briefly mentions mechanical testing, interface evaluation, dose distribution, end-to-end testing, and radiation safety, but these are engineering and physics validations for a physical medical device, not a performance study for an AI algorithm as typically requested in your prompt.

Therefore, I cannot extract the requested information points from this document. The prompt asks for details pertinent to an AI/ML device "study that proves the device meets the acceptance criteria," which is not applicable to this physical accessory.

If you have a different document describing an AI/ML device, please provide that, and I will be happy to attempt to answer your questions.

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