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The S-250 is intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation.

The S-250 is a medical device indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.

The S-250 is a low cost, one-room integrated device designed to administer proton radiation treatments to patients through delivery of a predetermined radiation dose to a pre-determined three dimensional treatment target volume in a manner that protects the patient, and hospital staff, from unnecessary exposure to radiation and other hazards.

The S-250 design requires a very compact proton accelerator which is supported on a rotating gantry such that a proton treatment beam can be directed toward the rotational center of the gantry over a range of about 180 degrees (straight up to straight down). The gantry holds the cyclotron at a large enough distance from the rotating arm(s) that a full treatment room floor can be extended around the treatment center and a treatment couch can support a patient over a large rotational (couch) range at isocenter.

The system will be a completely integrated system incorporating all functionality necessary to efficiently treat patients with proton beams. As such it incorporates near real time radiographic based patient alignment and coupled patient support devices (couch) with broad flexibility for supporting the patient relative to the treatment beam. The couch is capable of six-degree-of-freedom adjustment and be able to rotate about a vertical axis in a range of about 270 degrees, so as to provide full coverage of beam directions typically used in radiation therapy

To keep high precision of alignment of the field specific device (range compensator and apertures) to the patient, these devices will be supported on a separate gantry, close to the treatment center and not physically connected to the large gantry supporting the cyclotron. This will lighten the aiming requirements for the large gantry.

The S-250 is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose and dose distribution to the prescribed patient treatment site as provided by a separately marketed Treatment Planning System (TPS) not distributed by Mevion Medical Systems. The S-250™ is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the prescription parameters are properly delivered. The other is the beam generating system whose function is to generate the proton beam and direct it to the beam delivery system.

The provided document, K120676 for the Mevion S-250 Proton Radiation Beam Therapy System, does not include a detailed study proving the device meets specific acceptance criteria in the manner typically seen for diagnostic AI/ML devices. Instead, it is a 510(k) Premarket Notification Summary for a medical device that relies on substantial equivalence to predicate devices.

Here's an breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the format of a table with specific performance metrics and acceptance criteria. The document states:
"Performance data demonstrates that the S-250 is as safe and effective as the predicate devices listed herein."

The acceptance criteria here are implicitly tied to the performance deemed acceptable for the predicate devices, implying that the S-250 meets those established safety and effectiveness standards through its design and testing. The document highlights that "The S-250 does not require new technical innovations beyond existing technologies" and lists various components that use conventional or straightforward design extensions.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable and not provided because a clinical study with a test set of patient data, as would be common for an AI/ML diagnostic device, was not conducted to demonstrate efficacy. The device is a radiation therapy system, and its efficacy is based on the established clinical utility of proton beam radiation therapy generally, and its substantial equivalence to other legally marketed proton therapy systems.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided. Ground truth in the context of an AI/ML diagnostic study is not relevant here as there was no such study performed.

4. Adjudication Method for the Test Set

This information is not applicable and not provided.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described in the document. The filing explicitly states: "The S-250 Proton Beam Radiation Therapy System offers no additional or changed diagnostic or therapeutic claims beyond the stated predicate devices. Therefore, demonstration of clinical efficacy is not a required element of this premarket notification." The document mentions a "Clinical Data Evaluation Report that summarizes peer-reviewed literature related to the clinical efficacy and safety proton beam radiation therapy systems," but this is a literature review, not a new comparative effectiveness study of the S-250.

6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)

This information is not applicable as the S-250 is a physical medical device (a proton radiation beam therapy system), not an algorithm or AI/ML software. Its intended use involves trained healthcare professionals.

7. Type of Ground Truth Used

Not Applicable for a direct device assessment as described in an AI/ML context. The "ground truth" for the S-250's deemed safety and effectiveness is its adherence to engineering and design standards, demonstration of proper function, and its substantial equivalence to established proton therapy systems that already have clinical efficacy demonstrated through years of use and literature.

8. Sample Size for the Training Set

Not Applicable. The S-250 is a hardware system, not an AI/ML model that is 'trained' on data in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not Applicable.

Summary of Device Acceptance and Study:

The acceptance of the Mevion S-250 system by the FDA, as detailed in this 510(k) summary, is primarily based on the Substantial Equivalence pathway.

The "study" that proves the device meets acceptance criteria is not a clinical trial with patient data or an AI/ML validation study. Instead, it relies on:

• Technological Comparison: The document meticulously compares the S-250's various components (e.g., high field magnet, radiofrequency system, beam extraction, gantry, dosimetry) to existing technologies and designs, asserting that it "does not require new technical innovations beyond existing technologies."
• Predicate Device Comparison: The S-250 is compared to several legally marketed predicate proton therapy systems (Harvard Cyclotron Lab, IBA Proteus 235, LLUMC, Indiana University Cyclotron Facility, Hitachi PROBEAT, Varian pt2). The core argument for substantial equivalence is that the S-250 and these predicates "have substantially the same Intended Use and principles of operation, and are substantially equivalent in terms of performance and technological characteristics."
• Performance Data (Implicit): The conclusion "Performance data demonstrates that the S-250 is as safe and effective as the predicate devices" implies that Mevion conducted internal verification and validation testing to ensure the S-250 performs to engineering specifications consistent with the safety and operational principles of the predicate devices. The document references "Verification and Validation Testing" and "Design Reviews" to ensure fulfillment of design requirements and product safety/efficacy.
• Risk Analysis: A "System Hazard Analysis" was performed to identify and mitigate potential health and safety hazards.
• Quality System Compliance: Mevion's quality system is stated to be in compliance with FDA Quality System Regulations, ISO 9001, ISO 13485, ISO 62304, ISO 14971, and the MDD.

The FDA's clearance (K120676) signifies that the agency agreed with Mevion's assessment that the S-250 is "substantially equivalent" to existing devices and thus safe and effective for its intended use, without requiring new clinical efficacy data for the device itself.

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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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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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