(55 days)
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts.
The FluoroPro RF Digital Imaging System is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The FluoroPro RF Digital Imaging System allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images (1024) may be acquired at single or rapid acquisition rates, up to 30 fps. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for medium term storage. The FluoroPro RF Digital Imaging System enables the operator to hardcopy image with a laser printer or send images over a network for longer term storage. The major system components include: a fluoroscopic TV camera, monitors, and an image processor.
The provided documentation describes the FluoroPro RF Digital Imaging System, a fluoroscopic X-Ray system, and its substantial equivalence to a predicate device. The core of the submission focuses on demonstrating similarity to a legally marketed device rather than proving performance against specific acceptance criteria in a comparative clinical study.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The submission does not present explicit "acceptance criteria" in the traditional sense of a clinical trial (e.g., target sensitivity, specificity). Instead, it demonstrates performance by showing equivalence to a predicate device based on technical characteristics. The table below summarizes these characteristics and how the new device compares to the predicate.
| Characteristic | Predicate Device (Infimed Orion Digital Imaging System, K012490) | FluoroPro RF Digital Imaging System (New Device) | Performance Against "Acceptance Criteria" (Equivalence) |
|---|---|---|---|
| Intended Use | Acquisition, display, storage, and transmission of fluoroscopic images | SAME | Meets (Identical) |
| Power source | 120 VAC 50/60 HZ 7 amps | 120 VAC 50/60 HZ 2.5 amps | Different, but considered acceptable (likely an improvement in efficiency) |
| Image acquisition | Up to 15 FPS (spot), up to 30 fps (fluoro) | SAME | Meets (Identical) |
| File compatibility | DICOM | SAME | Meets (Identical) |
| CCD | Innovision CCD | Thales CCD | Different, but not deemed a substantial difference affecting safety/effectiveness |
| Digital Resolution | 1024 x 1024 12 bit | SAME | Meets (Identical) |
| Performance Standard | US FDA | SAME | Meets (Identical) |
| Electrical safety | SAME | SAME | Meets (Identical) |
Study that Proves the Device Meets the Acceptance Criteria:
The documentation states: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." and "After analyzing both bench and user testing data, it is the conclusion of Virtual Imaging that the FluoroPro RF Digital Imaging System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."
This indicates that the "study" was primarily bench testing (evaluating technical specifications, performance parameters, and compliance with standards) and user testing (likely validation by trained personnel in a simulated or controlled environment to confirm functionality and usability). The goal of these tests was to demonstrate substantial equivalence to the predicate device, not to meet specific quantitative clinical performance metrics like sensitivity or specificity.
2. Sample sized used for the test set and the data provenance
The document does not provide details on the sample size used for the "bench and user testing." It also does not specify the provenance of any data (e.g., country of origin, retrospective/prospective), as it relies on technical and operational comparisons rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. Given that the submission focuses on substantial equivalence based on technical specifications and functional testing, it's unlikely that "ground truth" for diagnostic accuracy was established by medical experts in the way it would be for an AI-powered diagnostic device. The "user testing" likely involved qualified technicians or doctors evaluating the system's operational aspects, image quality for diagnostic interpretation (compared to the predicate), and ease of use.
4. Adjudication method for the test set
This information is not provided. As "ground truth" from experts for diagnostic accuracy in a clinical context isn't explicitly mentioned, an adjudication method for such a ground truth would not be detailed.
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 conducted or reported in this submission. This device is a digital imaging system (hardware and software for image acquisition and display), not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance is not applicable here.
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. The device itself is an imaging system; its "performance" is tied to its ability to acquire and display images comparable to a predicate device, and it is intended for use by a "qualified/trained doctor or technician." It is not an autonomous diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device (a digital fluoroscopic x-ray system), the "ground truth" used for validation would primarily relate to its technical performance and image quality, not disease diagnosis. This would involve:
- Technical Specifications: Confirming that the system meets its stated parameters (resolution, frame rate, power consumption, etc.) through engineering tests.
- Image Quality Assessment: Evaluating the acquired images against established standards or by comparison to the predicate device for clarity, contrast, and diagnostic interpretability by a qualified user. This often involves phantoms and possibly human users assessing image quality visually.
- Safety Standards: Adherence to electrical safety and other relevant performance standards (e.g., US FDA performance standards mentioned).
There is no mention of ground truth established via expert consensus, pathology, or outcomes data related to diagnostic accuracy from patient images.
8. The sample size for the training set
This information is not applicable and therefore not provided. The FluoroPro RF Digital Imaging System is a digital X-ray system, not a machine learning or AI algorithm that requires a "training set" in the computational sense.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided, as there is no "training set" for this device.
§ 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.