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The IBA Proton Therapy System (PTS) 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 the treatment with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

IBA Proton Therapy System - Proteus 235 (PTS) is a proton beam irradiation system. 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 three primary components: (1) the beam management equipment, which includes a cyclotron, transport and delivery system to direct the proton beam to the patient's treatment location; (2) the position management equipment that allows bringing the patient and the proton beam in the adequate position for treatment and verifying the patient position; and (3) the treatment control system which controls the parameters of the proton beam treatment.

The scope of the current 510(k) premarket notification is to add a new version of the handpendant, which uses wireless and touch screen technologies to move equipment in the treatment room to the cleared IBA Proteus 235.

This document describes a 510(k) premarket notification for the "IBA Proton Therapy System - Proteus 235" with the addition of a wireless hand-pendant system. The submission aims to demonstrate substantial equivalence to a previously cleared device (K152224).

The acceptance criteria and device performance are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

This document describes a premarket notification for a modification to an existing device (adding a wireless hand-pendant). It is not a study involving patient data or a "test set" in the traditional sense of diagnostic or treatment efficacy. The testing described is primarily non-clinical performance testing of the device's components and system.

Therefore, there is no "sample size" of patients or data provenance in terms of country of origin or retrospective/prospective data for a clinical study. The tests were performed on the device and its sub-systems.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not a study requiring expert-established ground truth for a test set of medical cases. The "ground truth" for the non-clinical tests would be the established engineering specifications, recognized standards (e.g., electrical safety, EMC), and functional requirements of the device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There was no test set of medical cases requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a proton therapy system for radiation treatment, not an AI-assisted diagnostic or interpretation tool for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is a medical device for delivering radiation therapy, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests, the "ground truth" was based on:

• Recognized standards: For electrical safety and electromagnetic compatibility.
• Design requirements/specifications: For hardware performance, software functionality, latency, operating distance, and FCC radio frequency testing.
• Intended use and principles of operation: The fundamental basis for comparing the modified device to the predicate.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-based device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set, there is no ground truth established for one.

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The PTS is a medical device designed to product and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

The Proteus 235 system with Pencil Beam Scanning (PPBS) is an external beam irradiation system which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam to the designated patient treatment site with the assigned dose distribution. The equipment required to perform this work is comprised of the main components. The Beam Delivery System (BDS) has the primary responsibility to ensure that the prescribed beam parameters are properly delivered. The Beam Supply System (BSS) generates the proton beam. The pencil beam scanning is defined as the act of moving a charged particle beam or changing one or more of the properties of that beam (e.g. Intensity (e.g. # protons/second), size (e.g. 1 sigma), position etc.). The goal of this beam delivery is to deliver the appropriate proton fluence according to a prescription. The prescription provides a map of the fluence that is necessary to deliver at each location. The beam is moved to each location on the target and the appropriate fluence is deposited at each location.

This document, K082416, is a 510(k) summary for the IBA Proton Therapy System - Proteus 235. It describes modifications to an existing device, focusing on the addition of a Pencil Beam Scanning (PBS) capability.

However, the provided text does not contain acceptance criteria, device performance results, details of a study to prove acceptance criteria, sample sizes, data provenance, information on expert ground truth establishment, adjudication methods, MRMC studies, standalone performance data, or training set details.

The document primarily focuses on establishing substantial equivalence to predicate devices (Loma Linda University Proton Beam Therapy device and a pre-1976 Harvard University Cyclotron) based on intended use, technological characteristics, and functions. It describes how the Proteus 235, with its new PBS functionality, is similar to these predicate devices.

The FDA's 510(k) clearance letter (pages 3-5) confirms the substantial equivalence determination but does not delve into detailed performance studies or acceptance criteria, as that is typically contained in the full 510(k) submission, not the summary document provided.

Therefore, I cannot provide the requested table and study information based on the given input. The 510(k) summary is a high-level overview, and detailed performance data and acceptance criteria are usually part of the comprehensive submission package that is not publicly available in this format.

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