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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 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 tc 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 device 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 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 provided text is a 510(k) summary for the IBA Proton Therapy System-Proteus 235, specifically for an inclined beam line modification. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation studies for AI/ML devices.

The document is a regulatory submission for a modification to a medical device, focusing on demonstrating substantial equivalence to a previously cleared device. It does not present a performance study with acceptance criteria in the way a diagnostic or AI algorithm would.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document primarily discusses:

• Classification Name: Medical charged-particle radiation therapy systems. (21 C.F.R. §892.5050)
• Predicate Device: IBA proton therapy system (K983024)
• Intended Use/Indications for Use: To produce and deliver a proton beam for the treatment of localized tumors or other diseases susceptible to treatment by radiation.
• Description of Device Modifications: Addition of an inclined beam line, which is a simplified gantry accommodating two beam orientations (30° and 90°).
• Technological Characteristics: Creating and delivering the proton beam, producing appropriate dose distribution, and delivering the designated dose.
• Components: Beam delivery equipment, beam production equipment, Therapy Safety System, and Therapy Control System.
• Previously Added Features (from prior 510(k)s): PPVS (K053641), SIS and US (K060695), IOIS (K061913), Pencil Beam Scanning (K082416), Robotic PPS (K083058), Proteus RTT and patient gantry access upgrade (K091629).

This type of submission focuses on technical specifications and comparison to a predicate, rather than a clinical performance study with defined acceptance criteria and statistical analysis.

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The 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 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 is a 510(k) summary for the IBA Proton Therapy System (PTS). It details the device's intended use, modifications, and substantial equivalence to predicate devices, but does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. Multi-reader, multi-case (MRMC) comparative effectiveness study results or effect size
6. Standalone performance study results
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

This document is a regulatory submission focused on demonstrating substantial equivalence, not a performance study report.

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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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The 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 has two primary components: (1) the beam delivery equipment, which directs the proton beam to 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 modification in this submission is the addition of an automatic network-based interface from an Oncology Information System (OIS) to the PTS for the input of patient information, which information initially is entered into the OIS by means of a Graphical User Interface. After the patient treatment is completed, the treatment data is transferred from the PTS to the OIS through the automatic network-based interface.

This document is a 510(k) summary for the Ion Beam Applications S.A. Proton Therapy System (PTS). It is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the information required to answer your request in detail.

Specifically, the document does not describe or contain:

• Acceptance criteria and reported device performance in a table format.
• Details about a specific study proving the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
• Standalone (algorithm-only) performance results.
• Type of ground truth used (pathology, expert consensus, outcomes data).
• How ground truth for a training set was established.

This document focuses on establishing substantial equivalence to previously cleared predicate devices (Loma Linda University Medical Center Proton Beam Therapy device K872369 and Harvard University Cyclotron Laboratory Proton Beam Therapy device) based on intended use, principles of operation, and technological characteristics. It describes the device and its modifications (an automatic network-based interface from an Oncology Information System to the PTS), but not a performance study as you've requested.

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The 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 device has been modified to introduce two additional treatment modes: the Single scattering and the Uniform scanning. The Single scattering technique is a technique dedicated to the irradiation of fields smaller than seven centimeters in diameter. Single scattering decreases the amount of scattering in the nozzle compared to double scattering and lead to better lateral penumbra. Uniform scanning is an active technique for spreading beam in a transversal direction. The incoming narrow beam, whose size is a significant fraction of the field to be treated, is moved by magnetic scanning so as to yield a flat field. The beam is deviated in x and y directions by two magnets, making the beam travel along a saw-tooth pattern with rounded corners. A patient specific aperture and bolus need therefore to be used just as in double scattering mode. A Uniform Scanning session is composed of several mini-irradiations that are used to build a Spread Out Bragg Peak within the treatment volume that is divided in a stack of layers, each of them corresponding to one penetration depth.

This document is a 510(k) summary for a device modification to the IBA PROTON THERAPY SYSTEM - PROTEUS 235. The modifications introduce two new treatment modes: Single scattering and Uniform scanning. The summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as typically found in clinical trials for new medical devices.

Therefore, the requested information elements cannot be fully extracted directly from the provided text, as this type of regulatory submission has a different focus.

However, based on the information provided, here's what can be gathered and what cannot:

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

The document does not explicitly state "acceptance criteria" in a quantitative performance metric format for the newly introduced treatment modes. Instead, it relies on a comparison of technological characteristics to a predicate device to demonstrate substantial equivalence.

The table presented in the document (pages 2-4) focuses on comparing the new device modifications with the predicate device across various technical aspects. It primarily notes "No Change" for most characteristics, indicating that the core functionality and safety parameters are consistent with the legally marketed device. For the new features, it describes their characteristics rather than setting and meeting performance criteria against numerical targets.

For example, under "Beam Range Patient (Tissue Depth)", the document reports the following for the modified devices:

• Uniform Scanning: 3.5 cm to 32 cm in for 40x30cm field
• Single Scattering: 3.5 cm to 20 cm for Maximum field size 6 cm diameter field
• Predicate Device: 5 cm to 28 cm for Φ 10 cm field; 5 cm to 24 cm for Φ 20 cm field

However, these are descriptive specifications, not acceptance criteria with pass/fail thresholds. The "performance" is inherently implied to meet the design specifications of the new modalities.

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

This document does not describe a "test set" in the context of clinical or performance data for the device modifications. The submission is for a device modification based on engineering and physics principles, not a clinical study requiring patient data. Therefore, information on sample size or data provenance is not applicable or provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As this is not a study involving human interpretation or clinical data requiring ground truth establishment by experts, this information is not provided.

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

Not applicable, as no test set requiring adjudication of findings is described.

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, not an AI diagnostic or assistance tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.

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

Not applicable. This refers to an automated system's performance, which is not the primary focus of this device modification (a physically controlled beam delivery system). The performance of the beam characteristics would be assessed through physical measurements and simulations, but the document does not detail these specific tests or their results beyond the reported specifications.

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

Not applicable. The "ground truth" for a proton therapy system's physical parameters (like range, field size, scattering properties) would be based on established physics principles, validated simulation models, and direct physical measurements with dosimetry equipment. The document doesn't detail the experimental setup for proving the device characteristics, but it would not involve expert consensus, pathology, or outcomes data in the traditional sense for these technical specifications.

8. The sample size for the training set

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

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

Not applicable for the same reasons as point 8.

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The PTS with the Device Modification 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 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.

This Device Modification submission describes a necessary change in the Patient Positioning Verification System (PPVS). In the original 510(k) system that was cleared for marketing, referred to above (K983024), the patient positioning devices involved stand-alone hardware and the software for calculating a 6-axis patient positioning correction vector. Once that calculation was completed, the positioning correction vector had to be set manually in the proton therapy user interfaces.

With this Device Modification, the process will be similar to that in the original submission. The modification is that the Patient Positioning Verification System (PPVS) will be interfaced to a Treatment Planning System (TPS) or an Oncology information system (OIS) for downloading the treatment plan and the associated Digitally Reconstructed Radiographs (DRR) from the TPS in DICOM format. This contrasts with the original submission that transferred the PPVS via file servers or by using memory sticks. For this filing, we name the PPVS "DICOM Interfaced PPVS System."

This Device Modification primarily involves software changes, while the hardware generally is unchanged.

The provided text is a 510(k) summary for a device modification to an Ion Beam Applications' Proton Therapy System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies.

The "Device Modification" section only describes a software change to interface the Patient Positioning Verification System (PPVS) with a Treatment Planning System (TPS) or an Oncology Information System (OIS) for downloading treatment plans and Digitally Reconstructed Radiographs (DRR). It explicitly states that "This Device Modification primarily involves software changes, while the hardware generally is unchanged."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided input. This document serves as a regulatory submission (510(k)) to demonstrate substantial equivalence, not a detailed technical report on performance testing and acceptance criteria for a new or modified device feature.

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