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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 turnors and other conditions susceptible to treatment by radiation. »

The PTS is a medical device designed to produce and deliver a proton beam for treatment of a patient. It is intended for use in the therapeutic application of a proton beam for the treatment of localized tumours or other diseases that are susceptible to treatment by radiation. The PTS is comprised of beam production equipment which generates the beam used by the beam delivery systems. The technological aspects of a patient treatment consist of protons generated by the beam production equipment, directed to the patient's treatment site by the beam delivery system. The patient is put into the correct position relative to the beam by a positioning system. The PTS has two primary components: (1) the beam delivery equipment, which directs the proton beam to the patient's treatment site within the patient treatment location and ensures the patient critical functions are properly and safely accomplished; and (2).the beam production equipment. which includes a cyclotron and delivery system to produce the proton beam and deliver it to the patient treatment locations. In addition to these primary components, the PTS includes a Therapy Safety System to protect against unsafe conditions, having both automatic and manual controls to shut down the PTS in the event problems occur; and a computer-based Therapy Control System which controls the parameters of the proton beam.

The provided text describes a 510(k) submission for the IBA Proton Therapy System - Proteus 235, specifically for an interface to an external medical device called the universal beam triggering interface (UBTI). This submission does not contain the information requested regarding acceptance criteria and a study proving those criteria are met for a medical device.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results against specific acceptance criteria. It only states that "The adequate performance and safety test results have been provided to the FDA in the submission. The conclusions drawn from those tests demonstrate that the device is as safe, as effective, and performs as well as the already legally marketed device."

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

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