(83 days)
The ImagingRing System on rails (IRr) is an X-ray device consisting of imaging components, supports and software, designed to support patient localization and intended to be used as image guidance equipment as part of the radiation therapy (RT) treatment process, in all areas of the body where such image guidance is determined by a licensed physician. IRr facilitates patient localization by means of inaging patient anatomy including the therapeutic target volume, critical structures, bone and soft tissue with or without the use of implanted markers or contrast agents.
IRr provides 2D planar imaging (including recording sequences of 2D frames for motion analysis) and 3D volumetric imaging before, during and after irradiation, support pationing, monitoring and management of internal target motion, and decision making as a function of target position, size, shape and displacement resulting from patient set-up deviation, organ deformation and anatomical movement.
With the goal to accurately perform patient alignment with respect to an external treatment beam and to spare critical organs surrounding the target volume, the IRr is intended to be embedded in the radiotherapy workflow, i.e. being able to communicate with third party systems used in particle therapy or LINAC based RT such as Oncology Information Systems (OIS) or Radiotherapy Control Systems (RTCS) - receiving commands and data from and providing information to these party systems (e.g., receiving command from RTCS to start an image acquisition and providing image data. providing input for third party RTCS for repositioning of the patient).
This Traditional 510(k) describes modifications made to the medPhoton ImagingRing System. The kev differences are:
- In contrast to the existing ImagingRing System. where the ring (imager gantry) is mounted ● on the patient table, in the current system, the ring is mounted on a ceiling-mounted rail which allows longitudinal movement of the ring.
- Thus, the ImagingRing System on Rails does not include the patient table. ●
- The diameter of the gantry (ring structure carrying the imaging components X-ray generator ● and flat-panel detector) has been increased, providing bigger gantry clearance. This is facilitating positioning of the patient relative to the ImagingRing System on Rails using a Patient Positioning System (PPS) that is provided and controlled by a system integrator since not part of the ImagingRing System on Rails.
- A new control console, being used as human machine interface, has been developed to ● improve usability and to simplify imaging workflows (Control Console 2.0).
- In addition to the existing basic and slightly extended software (ImagingRing Software ● Suite), front-end software (medPhoton controls) was added to simplify imaging workflows and integration with overall radiation therapy workflow software that is provided and controlled by a svstem integrator.
The remaining characteristics and the basic technology have remained the same. The same essential components (X-ray generator and -detector, control system, etc.) are used.
Similar to the ImagingRing System, the ImagingRing System on Rails (Rr) is an X-ray imager that is intended to be integrated into a radiation therapy treatment system (e.g. a proton therapy system with its subsystems and workflows) by a system integrator. A major reason for the further development of the ImagingRing System has been to provide a simpler X-ray imager integration option for system integrators.
The medPhoton ImagingRing System on Rails (IRr) is an imaging system designed to obtain Two-Dimensional (2D) and Three-Dimensional (3D) X-ray images. The images visualize patient's anatomy whose information can be used to accurately position or re-position the patient undergoing radiotherapy treatment.
The IRr consists of
- . hardware called ImagingRing (IR) consisting of rails for longitudinal movement, ring gantry, flat-panel detector, X-ray source, generator, control cabinet, control console;
- software comprising the ImagingRing Software Suite (ImRiSS) and the medPhoton ● Controls (mPc) to orchestrate image acquisition and data processing;
- programmable logic controller (PLC) components and related software (ImagingRing ● Control System - ImRiCS), to execute and control motion and image acquisition.
The provided text does not contain information about studies proving that the ImagingRing System on Rails meets specific acceptance criteria related to its performance in terms of diagnostic accuracy or clinical effectiveness. The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria for AI-assisted or standalone diagnostic capabilities.
The document discusses the device's technical specifications and adherence to safety and performance standards (e.g., IEC 60601 series, IEC 62304, IEC 62366, ISO 14971) and outlines performance characteristics like spatial resolution, low contrast visibility, and geometric accuracy for both 2D and CBCT imaging. However, these are presented as technical specifications, not as results from a study against specific acceptance criteria for diagnostic performance or human reader improvement with AI assistance.
Specifically, the document states:
- "Summary of performance testing: The system is subject to compliance testing to voluntary consensus safety standards. Details of the standards employed in the design are specified in chapter 9... The results from verification and validation testing prove the conformance to applicable standards and demonstrate that safety & effectiveness have been achieved."
- "medPhoton GmbH did not perform any animal testing for the ImagingRing System on Rails."
- "medPhoton GmbH did not perform any clinical testing for the ImagingRing System on Rails."
Based on the provided text, it's not possible to populate the requested table or answer the questions related to clinical performance studies, such as sample size, data provenance, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these types of studies were explicitly stated as not performed.
Therefore, I cannot provide a detailed answer to your request as the information is not present in the provided text.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.