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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

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The Proton Therapy System - Proteus 235 (brand names: Proteus ONE) 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 of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

The Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) 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 system includes a proton accelerator (either an isochronous cyclotron (C230) or a Superconducting Synchro-Cyclotron (S2C2)) for beam production, which can be shared between several treatment rooms or directed to a single room. The system can be equipped with different types of treatment rooms, such as fixed beam or gantry rooms, connected to the beam line. The change introduced in this filing is the option of a new IBA Compact Beam Production System (CBPS) based on a Superconducting Synchro-Cyclotron (S2C2).

The provided text contains information about a 510(k) premarket notification for a Proton Therapy System, specifically focusing on the introduction of a new Compact Beam Production System (CBPS) feature. However, it does not include the type of study typically associated with device performance against acceptance criteria for diagnostic or AI-based devices (e.g., studies involving human readers, ground truth establishment through expert consensus, or performance metrics like sensitivity/specificity).

Instead, the document details the technical specifications and comparative performance of a radiation therapy system, which is evaluated based on physical beam characteristics and operational parameters rather than diagnostic accuracy.

Therefore, many of the requested items (e.g., sample size for test set, expert qualifications, MRMC study, standalone performance for diagnostic tasks, training set details) are not applicable or not present in the provided text for this type of medical device.

Here's an attempt to answer the applicable questions based on the provided text, while noting the limitations:

1. A table of acceptance criteria and the reported device performance

The document provides a table comparing key clinical beam performance characteristics. While not explicitly termed "acceptance criteria" in the context of diagnostic performance, these are the parameters against which the new CBPS feature is evaluated for equivalency to the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the text. The evaluation is based on "testing performed at the system and sub-system level" rather than patient or diagnostic data.

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

This is not applicable as the device is a radiation therapy system, not a diagnostic device requiring expert interpretation of images or patient data for ground truth. The 'ground truth' for this type of device would involve physical measurements and technical specifications.

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

This is not applicable for the reasons stated above.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable as this is a radiation therapy system, not an AI-assisted diagnostic device. The study is comparing the technical performance of a new component (CBPS) to an existing one.

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

This is not applicable in the context of an AI algorithm, as this device is a physical system. The "standalone performance" is implicitly the performance of the system as described in the table, without human interaction in its beam delivery characteristics.

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

The "ground truth" for this device's performance would be established through physical measurements and engineering specifications (e.g., beam range, field size, spot size, irradiation time) using phantoms or measurement equipment, rather than expert consensus on diagnostic images or pathology. The text states "Testing has been performed at the system and sub-system level."

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device that would require a "training set" in the conventional sense.

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

This is not applicable.

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