(202 days)
The ImagingRing System (IRS) is an X-rav device consisting of (1) imaging components, supports and (2) patient support structure (couch top), designed to support patient localization in the Couch Coordinate System (CCS) 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.
IRS facilitates patient localization by means of imaging patient anatomy including the therapeutic target volume, critical structures, bone and soft tissue with or without the use of implanted markers or contrast agents.
IRS provides 2D planar imaging (including streaming and recording sequences of 2D frames for motion and 3D volumetric imaging before, during and after irradiation, and is intended to support pationing, monitoring and management of internal target motion, and decision making as a function, 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, IRS 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) in order to receive commands and data from and provide information to (e.g., receiving command from RTCS to start an image acquisition and providing image data to RTCS for the purpose to calculate and execute the patient (re)-positioning vector externally in the third party system)
· interfaced with a Patient Positioning Systems (PPS), like - but not limited to - a robotic multi-axis system, to allow the calculated (re)-positioning vector to be applied with respect to Coordinate Systems the treatment delivery unit relates to.
The medPhoton IRS is a standalone imaging system designed to obtain TwoDimensional (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 IRS consists of
- · hardware called ImagingRing (IR) consisting of couch top, ring, detector, X-ray source, generator, etc .;
- · software called ImagingRing Software Suite (ImRiSS), to orchestrate image acquisition and data processing:
- . programmable logic controller (PLC) components and related software (e.g., ImagingRing Control System - IRCS), to execute and control image acquisition.
The system is designed in a way such that it provides the following key features:
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- During imaging acquisition, the IR can be moved along the couch top in order to acquire images of any anatomical region of interest.
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- The X-ray source and detector can move independently in order to enable nonisocentric acquisition trajectories (i.e., to focus on a selectable center of interest within the patient in an axial plane) and variable size of the axial Field Of View (FOV).
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- The combination of imaging arm and couch top is designed to be directly attached to a range of Patient Positioning Systems (PPS) including multi-axis robotic devices.
The imaging device is integrated with a couch top. The independently moveable components allow for acquisition of X-ray projective images. These provide the foundation for 2D planar imaging as well as acquisition and reconstruction of 3D ConeBeam Computed Tomography (CBCT) images around customizable centers of interest.
The provided text describes the medPhoton ImagingRing System (IRS) and compares its characteristics to predicate devices (Elekta XVI R5.0 and Qfix kVue) to demonstrate substantial equivalence for FDA 510(k) clearance. However, the document does NOT contain details about a specific study proving the device meets acceptance criteria. Instead, it outlines performance characteristics and states that testing was performed to evaluate safety and performance requirements.
Therefore, the following information will be extracted from the comparison tables and accompanying text. Aspects not mentioned in the document will be explicitly stated as "Not mentioned in the provided text."
1. A table of acceptance criteria and the reported device performance
The document presents performance characteristics by comparing the ImagingRing System's specifications against those of predicate devices. The values for the predicate devices essentially serve as the "acceptance criteria" or benchmarks that the new device aims to match or exceed for substantial equivalence.
| Characteristic | Acceptance Criteria (Predicate Device XVI R5.0) | Reported Device Performance (ImagingRing System) |
|---|---|---|
| Position Accuracy | ±0.3° | ±0.2° |
| 2D low contrast visibility | ≥12 disks visible | ≥12 disks visible |
| 2D spatial resolution | ≥1.4 line/mm | ≥1.6 line/mm |
| CBCT spatial resolution | ≥7 lp/cm | ≥10 lp/cm (up to 18) |
| CBCT low contrast resolution |
§ 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.