(46 days)
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.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.