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The IRm is a mobile X-ray system to be used for 2D planar and fluoroscopic and 3D imaging for adult and pediatric patients. It is intended to be used where 2D and 3D information of anatomic structures such as bony and soft tissue and objects with high X-ray attenuation such as (metallic) implants is required.

The IRm provides an interface that can be used by system integration of the IRm with image guidance systems such as surgical navigation systems.

The Mobile ImagingRing System (IRm, "Loop-X" or "Loop-X mobile Imaging Robot") is a robotic, digital X-ray system which supports both 2D planar and fluoroscopic X-ray and 3D Cone-Beam Computed Tomography (CBCT) image acquisition and reconstruction of a patient's anatomical regions of interest (ROI).

The design of the Mobile ImagingRing is based on a ring-gantry ("ring") with two arms mounted: the first arm on gantry carries a monoblock X-ray source and a collimator, the second holds a flat-panel detector. The two arms are independently moveable to accommodate individual patient setups and off-center imaging of regions of interest.

The ImagingRing m / Loop-X Imaging Robot is intended for mobile use on patients in general and interventional radiology, in sterile and non-sterile areas. The system can be used for diagnostic and interventional purposes by volumetric or planar X-ray imaging and enables image-quided maneuvers and operations in medical fields such as general surgery. traumatology, orthopedics, neurology or radiotherapy. The system is designed for flexible examinations and treatments with patients lying, sitting or standing, with and without contrast agent. It can also be combined with therapy devices such as linear accelerators, particle beam delivery systems or other irradiation devices with active sources and patient positioning systems in Image Guided Radiation Therapy, Intraoperative Radiation Therapy, Brachytherapy or surqical navigation and assistance systems as well as in combination with surgical robots in lmage Guided Surgery, in which the image data provided by the ImagingRing IRm / Loop-X m can be used directly with patient in situ to control the respective therapy maneuvers. Using additional equipment, such as external tracking cameras or the built-in optical cameras, the position of objects such as tracked surgical instruments or pointer tools, for example, can also be determined in the imaging coordinate system. This position data, in combination with the patient's pre- and intra-interventional imaging data, can be used in guided or navigated workflows. The internal cameras of the IRm can also be used to capture pictures and film sequences of the medical procedures.

The provided text is a 510(k) summary for the medPhoton Mobile ImagingRing System (IRm, Loop-X Mobile Imaging Robot, Loop-X). This document describes the device and claims substantial equivalence to a predicate device, the Ziehm Vision RFD 3D (K142740).

The summary states that no clinical testing was performed for the Mobile ImagingRing System and no human studies were conducted. Therefore, there is no information to describe acceptance criteria based on human performance, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for clinical studies.

Instead, the submission relies on bench testing to demonstrate substantial equivalence to the predicate device and safety/effectiveness.

Here's a breakdown of the available information regarding testing:

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

The document does not provide a specific table of acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy for a particular task) and reported device performance in a clinical context with human readers or AI performance.

Instead, it states:

• "Results suggest that the subject device performs at least as good as the predicate device (in terms of resolution capabilities) or better (in terms of a larger dynamic range) and therefore support the demonstration of substantial equivalence."

This indicates that internal performance metrics, likely derived from phantom and cadaver studies, were used to informally compare the subject device's image quality (resolution, dynamic range) to the predicate device. Specific numerical acceptance criteria or performance values are not listed.

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

• Test Set Sample Size: Not applicable in the context of clinical or AI performance studies from humans. The bench testing involved "phantoms and cadavers." The exact number of phantoms or cadavers used is not specified.
• Data Provenance: Not applicable for human data. The source of the phantoms and cadavers is not specified. The testing was conducted "internally (by medPhoton) and by an external accredited testing laboratory."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as no clinical studies with human readers or AI performance were conducted. Ground truth for phantom and cadaver studies typically involves known physical properties or measurements, not expert consensus on medical findings.

4. Adjudication method for the test set:

• Not applicable as no clinical studies with human readers or AI performance were conducted.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission pertains to an imaging device itself, not an AI algorithm designed to assist human readers.

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

• No, a standalone algorithm performance study was not done. This device is an X-ray system, not an AI algorithm.

7. The type of ground truth used:

• For the bench testing, the ground truth would have been based on the known physical properties and characteristics of the phantoms and cadavers used. The document mentions "resolution capabilities" and "larger dynamic range" as performance metrics, which are objectively measurable properties of the imaging system.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device, and no AI training datasets are mentioned.

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

• Not applicable as this is not an AI/ML device, and no AI training datasets are mentioned.

Summary of Device Performance Testing Provided (Non-Clinical):

The submission highlights the following aspects of performance testing:

• Bench Testing: Conducted to support substantial equivalence.
  • System level validation was performed to ensure the device meets customer and system requirements and performs according to its intended use.
  • Clinical imaging performance was tested using phantoms and cadavers.
  • Results indicated that the subject device performs "at least as good as the predicate device (in terms of resolution capabilities) or better (in terms of a larger dynamic range)."
  • Additional bench testing addressed mechanical characteristics to demonstrate safety and effectiveness of the device's design.
• Voluntary Consensus Standards: Compliance demonstrated through internal and external testing (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54, IEC 62304, IEC 62366, and ISO 14971).
• Animal Testing: None performed.
• Clinical Testing: None performed.

The substantial equivalence claim for K203281 is based on the declared equivalence in intended use, technological characteristics, and safety and effectiveness demonstrated through non-clinical bench testing comparing the device to prior predicate and reference devices.

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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.

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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:

• 1. During imaging acquisition, the IR can be moved along the couch top in order to acquire images of any anatomical region of interest.
• 2. 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).
• 3. 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.

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