(92 days)
The Wired/Wireless FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The FDR D-EVO (DR-ID 600) is not intended for mammography, fluoroscopy, tomography and angiography applications.
The Wired/Wireless FDR D-EVO (DR-ID600/DR-ID601.SE) flat panel detector (FPD) system consists of the Fujifilm D-EVO detector, Fujifilm D-EVO system control cabinet, and power supply unit. Images captured with the flat panel digital detector can be communicated to the operator console via tethered connection. Data captured via operator console is sent electronically to the Fujifilm FDX Console to be displayed on the monitor.
Wired/Wireless FDR D-EVO flat panel detector is an indirect-conversion amorphous silicon (a-Si) portable flat panel detector utilizing GOS (Gadolinium OxySulfide) as a scintillator. Wired/Wireless FDR D-EVO detector has Fuji's unique Irradiation Side Sampling system (hereinafter "ISS system").
The X-ray Detection Feature is a minor change to our cleared Wired/Wireless FDR D-EVO FPD detector system which eliminates the need for an electrical interface between the D-EVO system's DR-ID 600 MP and the x-ray exposure system. This is accomplished by incorporating X-ray sensors into the exposure surface of the proposed Wired/Wireless FDR D-EVO Flat Panel Detector.
The provided document describes a Special 510(k) Premarket Notification for the Wired/Wireless FDR D-EVO with X-ray Detection Feature. Here's an analysis of the acceptance criteria and study findings based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in a structured table format with specific metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, etc.). Instead, the performance evaluation is based on a qualitative assessment of diagnostic equivalence.
| Evaluation Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Image Quality | Images from the proposed device (with X-ray Detection Feature) must be diagnostically equal to images from the predicate device (without the feature). | "all participants found the D-EVO images with the X-ray Detection Feature were diagnostically equal to the predicate device images." |
| Artifact Presence | X-ray sensors incorporated into the exposure surface should not be visible in the image. | "No participant was able to visualize the X-ray sensors." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "Identically exposed and processed anthropomorphic phantom image pairs (proposed device vs. predicate device)". The exact number of image pairs or phantom cases is not specified.
- Data Provenance: The study was conducted using "anthropomorphic phantom image pairs." The country of origin of the data is not specified, but it was an internal study by Fujifilm. The study type was retrospective in the sense that images were captured and then evaluated, but it wasn't a clinical retrospective study of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: The images were judged by "3 Fujifilm Imaging Specialists, as well as a board-certified radiologist." This makes a total of 4 experts.
- Qualifications: "board-certified radiologist" and "3 Fujifilm Imaging Specialists." The specific years of experience for the radiologist or the imaging specialists are not provided.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated. The document only mentions that the images were "judged by" the experts. It's unclear if a consensus was formed, or if individual opinions were aggregated, or if the radiologist's opinion was given more weight. However, the reported outcome "all participants found the D-EVO images...were diagnostically equal" suggests a unanimous agreement or a consensus process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance was not done. This study focused on comparing the image quality of a modified device (with X-ray detection feature) against its predicate device, not on AI assistance for human readers.
6. If a Standalone Study Was Done
No, a standalone study (algorithm only without human-in-the-loop performance) was not done. The study involved human experts evaluating images produced by the device. The device itself (the flat panel detector) is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the test set was indirectly inferred through expert consensus/opinion on "diagnostic equivalence" and visibility of artifacts in anthropomorphic phantom images. Since it's a comparison of two devices capturing phantom images, there isn't a "pathology" or "outcomes data" type of ground truth in the traditional sense. The baseline for comparison was the predicate device's image quality.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as the device is a hardware component (a flat panel detector) and not an AI/machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
As point 8 indicates, there was no training set for this device as it is not an AI/machine learning product.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.