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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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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.

The PTS may include a Fixed Small beam Treatment Room dedicated to treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localised to the head and neck.

The PTS is a 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 device is designed to: (1) create and deliver the proton beam to the patient treatment location: (2) produce a transverse and longitudinal dose distribution appropriate for the patient's treatment; and (3) deliver the designated dose to the patient's treatment site. 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 scope of this 510(k) submission comprehends a fixed beam treatment room customised for small beams that can accommodate sitted treatment.

This document (K100766) is a 510(k) summary for a medical device called the "IBA Proton Therapy System - Proteus 235." It is a proton therapy system used for treating localized tumors and other conditions susceptible to radiation treatment. The submission describes modifications to an existing proton therapy system.

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it contain any of the other requested details such as sample sizes, expert qualifications, adjudication methods, or MRMC studies.

This document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device (IBA proton therapy system K983024) under 21 CFR 892.5050. It describes the device's intended use, technological characteristics, and a series of modifications made to the original system over time (e.g., PPVS, SIS and US, IOIS, Pencil Beam Scanning, Robotic PPS, Proteus RTT, and Inclined Beam Line).

The FDA's letter (Exhibit 3) confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices. This indicates that the device meets the regulatory requirements for market clearance based on its similarity to previously cleared devices, rather than through a novel performance study against specific acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions based on the provided text. The document's purpose is to establish regulatory equivalence, not to present a clinical validation study with detailed performance metrics.

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