Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Optivus Technology, Inc.'s Proton Beam Therapy System (PBTS) is an integrated facility designed to administer proton radiation treatments to patients through delivery of a predetermined radiation dose to a predetermined treatment target volume in a manner that protects people from unnecessary exposure to radiation and other hazards.

The Optivus Proton Beam Therapy System (PBTS) is an integrated facility designed to deliver radiation treatment. Optivus' proposed facility is essentially the same as the facility that is currently operating at LLUMC. Both facilities consists of three major functional blocks; the accelerator, the beam transport system, and the treatment rooms. This complete, turnkey system consists of seven major subsystems:

• 70 - 250 MeV proton synchrotron;
• beam transport system;
• . one or more fixed beam delivery systems;
• . one or more isocentric gantries;
• patient positioning system;
• integrated facility control system; and .
• integrated facility safety system.

This document describes a 510(k) premarket notification for the Optivus Proton Beam Therapy System (PBTS). The submission seeks to demonstrate substantial equivalence to a predicate device, the Loma Linda University Medical Center (LLUMC) PBTS, which was already cleared for marketing.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance

The report does not define explicit quantitative "acceptance criteria" through specific performance metrics like sensitivity, specificity, accuracy, or other benchmark values. Instead, the basis for approval is establishing substantial equivalence to a predicate device. This means the Optivus PBTS must demonstrate that it is as safe and effective as the LLUMC PBTS.

The "reported device performance" is presented through a comparison matrix, highlighting the technological characteristics of the Optivus PBTS and showing them to be the "Same as LLUMC PBTS" or having comparable specifications.

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

• Sample Size: This 510(k) submission does not describe a test set or clinical study involving patient data. The "study" is a comparison of two device specifications.
• Data Provenance: Not applicable, as no external data set (patient or otherwise) is mentioned for performance evaluation beyond the device specifications themselves.

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):

• This question is not applicable. The "ground truth" here is the established and accepted specifications and performance of the predicate device (LLUMC PBTS). There's no mention of external experts being used to establish a "ground truth" for a test set for the Optivus PBTS. The FDA review process implicitly relies on the agency's experts to evaluate the technical comparison.

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

• This question is not applicable. There is no "test set" in the context of a clinical study that would require an adjudication method. The comparison is based on documented specifications of the two devices.

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:

• This question is not applicable. The device is a proton beam therapy system, not an imaging analysis AI or diagnostic aid that would involve human readers or AI assistance.

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

• This question is not applicable. The device is a physical radiation therapy system, not an algorithm.

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

• The "ground truth" in this context is the established and regulatory-cleared specifications and performance characteristics of the predicate device (LLUMC PBTS), which has been legally marketed. The submission's core argument is that the proposed device shares the same fundamental technological characteristics and principles of operation as this already-cleared device.

8. The sample size for the training set:

• This question is not applicable. There is no "training set" as this is not a machine learning or AI-based device requiring training data. The device is hardware.

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

• This question is not applicable. As there is no training set, there isn't a method for establishing its ground truth.

Ask a specific question about this device