(170 days)
The device is intended to be moved in a hospital or clinic or other facility to provide capability of X-ray exposures in remote areas, or in instances where stationary devices are unsuitable. The device is designed to be used in conjunction with a cassette film or other image receptor, in order to provide a radiological exposure of the human body, to serve as an aide in diagnosing illnesses and fractures. The unit is not intended to treat, prevent, cure, mitigate or otherwise medicate ailments.
THE UNIT IS INTENDED FOR USE ON GENERAL RADIOGRAPHIC PROCEDURES.
The device appears as a mobile unit and is composed of three parts: The X-ray generator (monoblock), the X-ray controller, and the mechanics which allow the device to be moved on wheels and the X-ray generator to be positioned. The X-ray generator is constituted of an X-ray tube with rotating anode, encased in metal casing which also contains the high voltage generator. The monoblock is attached to a Beam Limiting Device (BLD). The monoblock and the X-ray emission are controlled by an X-ray controller, an electronic device connected to the monoblock through low tension cables. The device is designed to be transported on wheels and has an arm structure that supports the X-ray source, allowing for vertical and pivotal movements. The X-ray source is attached to the arm by means of gimbals, allowing z-axis and x-axis rotation. The BLD is also capable of swiveling on its vertical axis. The device performs X-ray exposures using a two-step push button, with the operator selecting kVp and mAs settings. The exposure process involves prepping the exposure (warming the filament and spinning the anode) and then initiating the emission of radiation. The X-ray controller monitors the process and can abort the exposure if problems are encountered. Exposures can also be manually aborted by the operator.
The provided text is a 510(k) Summary for an X-ray mobile unit, "Compact" or "Comp-X". This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a specific study proving those criteria.
Therefore, the requested information regarding acceptance criteria, a study proving conformance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not available in the provided text.
The document indicates that the device is "substantially equivalent" to the model MU125 manufactured by Shimadzu (510(k) number: K955036). This means the device is considered as safe and effective as the predicate device by meeting the same or similar technological characteristics and intended use. The substantial equivalence process itself serves as the "study" for this type of device, where the comparison is made against an already cleared product.
Here's an overview of what can be extracted based on the "substantial equivalence" framework provided in the document:
1. A table of acceptance criteria and the reported device performance:
Since this is a substantial equivalence submission for an X-ray mobile unit, the "acceptance criteria" are implicitly aligned with the performance and safety standards met by the predicate device (Shimadzu MU125) and general regulatory requirements for X-ray equipment. The document highlights the following characteristics of the Eurotec "Compact" or "Comp-X" as its "reported device performance" to demonstrate equivalence:
| Characteristic | Acceptance Criteria (Implied from Predicate/Regulatory Standards) | Reported Device Performance ("Compact" / "Comp-X") |
|---|---|---|
| Intended Use | X-ray mobile unit for radiographic exposures in various facilities for diagnosing illnesses and fractures. | Same as predicate: X-ray mobile unit for radiographic exposures in various facilities for diagnosing illnesses and fractures. Not for treatment/prevention. |
| kVp Range | Typically 40-120 kVp (as per predicate and general mobile X-ray unit capabilities) | 40 to 120 kVp |
| mAs Range | Typically a specific range (as per predicate and general mobile X-ray unit capabilities) | 0.5 to 100 mAs |
| Exposure Time | Varies based on technique settings (as per predicate and general mobile X-ray unit capabilities) | 5 milliseconds to 4 seconds |
| Operating Frequency | High frequency for quality images | High Frequency (HF) generator |
| Mobility | Designed to be transported on wheels | Transported on wheels, with various articulated movements of the X-ray head and BLD. |
| Radiation Safety | Includes a Beam Limiting Device (BLD) | Includes a BLD to limit X-ray beam and provide visual indication. |
| Safety Features | Mechanism to abort exposure, visual/audible signals for problems/abortions. | Exposure can be aborted manually; visual and audible signals for problems/abortions. |
| Components | X-ray generator, X-ray tube, BLD, control electronics, mobile mechanics. | Monoblock (X-ray tube with rotating anode, HV generator), BLD, X-ray controller, mobile mechanics. |
| Materials | Metal and radiation insulating material. | Metal and radiation insulating material (lead for X-ray head), zinc-coated metal for mechanics. |
It's important to note that these are characteristics used to justify substantial equivalence, not explicit "acceptance criteria" established for a performance study of the "Compact" device itself. The primary acceptance criterion here is "substantial equivalence" to the cleared predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. Substantial equivalence claims for X-ray mobile units typically rely on bench testing, electrical safety and electromagnetic compatibility (ES/EMC) testing, and comparison of technical specifications rather than clinical data with a test set of patient cases.
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 information is not applicable/provided. The submission does not describe a study involving clinical experts to establish ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. There is no described test set of patient cases requiring adjudication.
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 information is not applicable/provided. The device is an X-ray mobile unit, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant to its clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/provided. The device is hardware (an X-ray machine), not an algorithm, so standalone performance in that context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided. Ground truth for patient data is not described as part of this submission. The "ground truth" for this device's safety and effectiveness is its adherence to technical specifications, performance limits, and regulatory standards, demonstrated through physical testing and comparison to the predicate device.
8. The sample size for the training set
This information is not applicable/provided. The document does not describe any machine learning or AI components that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. No training set is mentioned or implied.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.