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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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Indiana University Cyclotron Facility's Proton Therapy System is a medical device intended to deliver proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation.

IUCF's PTS is a charged particle radiation therapy system. The PTS contains three major systems: the Cyclotron System (CYS), JUSTIS, and the Treatment Systems (TS). The TS is divided into seven subsystems to carry out the proton treatment process: the Treatment Room Control System (TRCS); the Kicker Enable System (KES); the Beam Delivery System (BDS); the Dose Delivery System (DDS); the Patient Positioning System (PPS); the MPRI Radiation Interlock System (MIRS); and the Emergency Stop System (ESS). These subsystems work together to generate the desired dose level and distribution at the target site. Treatment System 2 (TS2) of the PTS, the subject of this 510(k) notice, employs a rotating gantry, which allows the proton radiation beam to be delivered to the target site from any direction in a plane. The gantry includes the gantry structure; retractable gantry floor; Digital Radiography panel positioning systems; gantry safety mechanisms; and gantry rotation controls. Computer control of the gantry is provided by the PPS.

The provided text describes the Indiana University Cyclotron Facility's Proton Therapy System (IUCF PTS) as a medical device intended to deliver proton radiation treatment. However, it does not include a table of acceptance criteria or a detailed study proving the device meets specific performance criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Loma Linda Medical Center Proton Beam Therapy System (K872369) and Ion Beam Applications, SA's, Proton Therapy Systems (K983024, K060695)).

Here's a breakdown of what is recoverable from the text, and what is not:

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

• Not provided. The text states: "Extensive performance testing conducted at the system and subsystem (hardware and software) levels, and electromagnetic compatibility, electromagnetic interference ("EMC/EMI") and electrical safety demonstrated that the system and subsystems met or exceeded design specifications, clinical performance requirements and EMC/EMI and electrical safety applicable standards."
• This indicates that internal design specifications and clinical performance requirements existed and were met, but the specific criteria and results are not detailed in this 510(k) summary.

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

• Not provided. The document does not describe a clinical study with a "test set" in the context of patient data or outcomes. The "performance testing" mentioned refers to engineering and system-level validation.

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 / Not provided. Since there's no clinical "test set" with ground truth established by experts, this information is not present.

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

• Not applicable / Not provided. (See point 3)

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:

• No. This is a system for delivering radiation therapy, not an imaging or diagnostic AI device. Therefore, an MRMC study and AI assistance effect size are not relevant or discussed. The device is for treatment delivery, not interpretation.

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

• Not applicable / Not provided. The device is a treatment system, not a standalone algorithm. Its performance is demonstrated through its ability to deliver the intended proton radiation, which involves hardware and software working together. The "Performance Data" section indicates system-level testing.

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

• Not applicable / Not provided for clinical ground truth. The "ground truth" for this device would be its adherence to engineering specifications and its ability to accurately deliver a specified dose of proton radiation. The document states it "met or exceeded design specifications" and "functioned as intended."

8. The sample size for the training set:

• Not applicable / Not provided. This is a proton therapy system, not a machine learning model that requires a distinct "training set" of data in the typical AI sense.

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

• Not applicable / Not provided. (See point 8)

Summary of Device Acceptance Information Present in the Document:

The acceptance of the IUCF PTS is based on demonstrating substantial equivalence to existing legally marketed predicate devices rather than proving performance against specific quantitative acceptance criteria in a detailed clinical study.

Acceptance Criteria and Reported Device Performance (as inferred from the text):

Study Information:

• Type of Study: Not a typical clinical study with patient cohorts, but rather a technical performance testing and substantial equivalence argument.
• Test Set Sample Size: Not applicable as no patient-specific test set is described. Performance testing was conducted at "system and subsystem levels."
• Data Provenance: Not applicable for a clinical test set. The testing was likely conducted in a controlled engineering environment.
• Ground Truth Establishment for Test Set: Not applicable in the clinical sense. Ground truth was adherence to engineering design specifications and regulatory standards.
• Adjudication Method: Not applicable.
• MRMC Study: No.
• Standalone Performance Study: Performance testing was done at system/subsystem levels, which represents the device's standalone capability in delivering radiation according to design.
• Type of Ground Truth: Adherence to engineering "design specifications," "clinical performance requirements," and "EMC/EMI and electrical safety applicable standards."
• Training Set Sample Size: Not applicable.
• Ground Truth for Training Set: Not applicable.

In essence, the document serves as a regulatory filing (510(k) summary) to demonstrate that the device is "substantially equivalent" to already approved devices, rather than a detailed report of a new clinical trial or performance validation against explicit, public acceptance criteria.

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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.

This document is a 510(k) summary for the Ion Beam Applications S.A. Proton Therapy System (PTS). It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate device). It is not a process that typically requires clinical studies demonstrating performance against acceptance criteria in the way a PMA (Premarket Approval) might.

Therefore, I cannot provide the requested information because it is not present in the provided text. The document focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, principles of operation, performance, and technological characteristics, rather than presenting a performance study with defined acceptance criteria.

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