(129 days)
The Wireless/Wired 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 including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The FDR D-EVO is not intended for mammography, fluoroscopy, tomography, and angiography applications. The FDR D-EVO can be used with Virtual Grid Software, which is optional image processing software installed on Fujifilm's FDX Console. Virtual Grid Software can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.
Fujifilm's FDR D-EVO Flat Panel Detector System (DR-ID600) is a portable digital detector system that interfaces with, and acquires and digitizes x-ray exposures, from standard radiographic systems. The FDR D-EVO is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, pediatrics and neonates. The detector models support both wireless and wired/tethered data communication between the detector and the system. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid exams. The FDR D-EVO can be used with or without Virtual Grid Software, which is optional image processing software installed on Fujifilm's FDX Console. The Virtual Grid Software was originally designed to improve image contrast in general radiographic images by reducing the effects of scatter radiation, primarily for exams acquired without a grid. Initially, the anatomical regions of the software were for chests and abdomens only, where the effects of scatter radiation can be prominent if a grid is not used. The user can decide whether or not to apply the Virtual Grid image processing by turning it ON or OFF as they see fit based on the displayed image. The same software is also offered with other legally marketed Fujifilm DR Systems that use the same FDX Console as the acquisition workstation since this post-processing algorithm does not depend on how the image is acquired, or with what acquisition device. Since the K141765 clearance, however, several improvements have been made in order to expand the effectiveness of the Virtual Grid Software, which is the reason of the new submission. The improvements are 1) expansion of target body parts to cover the whole anatomy, 2) target image format to include images obtained by Fujifilm's CR systems, and 3) adding a new claim that Virtual Grid Software can be used in lieu of an antiscatter grid. An additional benefit of using the Virtual Grid Software involves X-ray radiation dose. It is a well-known practice that exposure conditions should be increased when a hardware grid is used in order to compensate for the primary X-ray energy absorbed by the grid strips. On the other hand, since the Virtual Grid processing can be applied to images taken without a grid. Virtual Grid can achieve image contrast equivalent to that of a hardware grid, but at lower dose levels than are needed when using a hardware grid. Based on Fujifilm's performance testing and image quality evaluation results, a maximum dose reduction of 50% when using VG with Fuiifilm DR detectors can achieve comparable image quality when compared to using a real grid. Virtual Grid Software comes with some limitations such as VG should not be applied to images that were acquired with a real grid. VG cannot be applied to images that were acquired prior to the VG software installation. VG can only be used for selected exposure menus listed in the manual. VG should not be used for images acquired with additional beam filtration. Device Integration: The FDR D-EVO can be used with any legally-marketed and appropriately certified X-ray source. If FDR D-EVO is used with the optional Hand Switch Interface Box, a connection to the X-ray source/qenerator's timing signals (prep and exposure signals) is necessary. Even if such timing signals are not available, the FDR D-EVO can acquire an image using Automatic x-ray detection function (known as 'SmartSwitch' in the US), so the limitation is neqligible.
The provided document describes the Fujifilm FDR D-EVO Flat Panel Detector System (DR-ID600) with Improved Virtual Grid Software, and its 510(k) submission (K153464) to the FDA. However, the document does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the format requested.
The document states:
- "As required by the risk analysis, all verification and validation activities related to the improvements made to the Virtual Grid Software were performed and the results were satisfactory."
- "Additionally the bench testing and image quality evaluation demonstrated that Virtual Grid Software can achieve image contrast equivalent to that of a hardware grid, but at lower dose levels than are needed when using a hardware grid. The results of the bench testing and image evaluation are provided in the submission."
- "The changes do not require clinical studies. The substantial equivalence has been demonstrated by non-clinical studies."
This indicates that internal testing (bench testing and image quality evaluation) was performed to demonstrate the device's performance, particularly regarding image contrast and dose reduction compared to a hardware grid. However, the specific acceptance criteria, detailed study design, sample sizes, ground truth establishment, or expert involvement are not publicly available in this FDA clearance letter.
Therefore, I cannot directly extract most of the requested information from the provided text. I will provide a summary of what is mentioned regarding performance and the nature of the studies.
Summary of Available Information from the Provided Document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Equivalent image contrast to hardware grid | Virtual Grid Software can achieve image contrast equivalent to that of a hardware grid. |
| Lower dose levels compared to hardware grid | Virtual Grid can achieve image contrast equivalent to that of a hardware grid, but at lower dose levels than are needed when using a hardware grid. |
| Dose reduction for comparable image quality | A maximum dose reduction of 50% when using VG with Fujifilm DR detectors can achieve comparable image quality when compared to using a real grid. |
| Satisfactory verification and validation activities for software improvements | All verification and validation activities related to the improvements made to the Virtual Grid Software were performed and the results were satisfactory. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified, but described as "bench testing and image quality evaluation," implying laboratory-based or simulated data rather than patient data for the performance claims. The changes "do not require clinical studies."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided document.
4. Adjudication method for the test set:
- Not specified in the provided document.
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 MRMC comparative effectiveness study is mentioned. The document states, "The changes do not require clinical studies," indicating no human reader study was conducted for this specific clearance. The focus was on the technical imaging performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance evaluation appears to be standalone, focusing on the technical image quality metrics through "bench testing and image quality evaluation." There's no mention of human readers being involved in the performance assessment for this submission.
7. The type of ground truth used:
- Implied ground truth: Comparison against images acquired with a physical anti-scatter grid (benchmark for image contrast and scatter reduction) and potentially objective image quality metrics (e.g., contrast-to-noise ratio, spatial resolution as implied by "bench testing"). The document does not specify the exact ground truth methodology.
8. The sample size for the training set:
- Not specified in the provided document.
9. How the ground truth for the training set was established:
- Not specified in the provided document. (It's unclear if a separate "training set" in the AI/ML sense was used, as the software is described as "image processing software," not explicitly an AI/ML algorithm requiring a distinct training phase in the context provided).
§ 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.