(90 days)
The Wireless/Wired FDR D-EVO II 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 II is not intended for mammography, fluoroscopy, tomography, and angiography applications.
Fujifilm's FDR D-EVO II Flat Panel Detector System (DR-ID1200) is a portable digital detector system that interfaces with, and acquires and digitizes x-ray exposures from, standard radiographic systems. The FDR D-EVO II 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 or free cassette exams.
While maintaining Fujifilm's unique Irradiated Side Sampling (ISS) design delivering high image quality. FDR D-EVO II offers the new and improved 1200 series flat panel detectors with upgraded wireless feature, memory exposure mode, and extended image readout feature. Additionally, the 1200 series detectors are equipped with several changes: Rounded-edge design for easy handling, image compression algorithm for faster image transfer, improved internal circuit design for electronic noise reduction, new LED design for easy detector identification, extra protection against ingress of water, and antibacterial coating designed to maintain cleanness. Not only the 1200 series detectors' robust design enhances load-bearing characteristics, but also the powersaving designs combined with the new battery packs and charger improve battery performance. The weight of 1200 series detectors is less than that of 600 series.
The provided document
"FUJIFILM Medical Systems U.S.A., Inc." (K142003)
is a 510(k) premarket notification for the "FDR D-EVO II Flat Panel Detector System (DR-ID1200)".
This document states that no clinical study was performed to demonstrate that the device meets acceptance criteria. Instead, substantial equivalence was demonstrated by non-clinical studies. This means there is no data on human clinical performance provided in this document to populate the requested table or answer several of the questions, as they pertain to clinical studies.
However, the document does mention non-clinical performance data and states that "the image quality evaluation confirmed that the image quality of the FDR D-EVO II system using new 1200 series detectors is substantially equivalent to that of the predicate device." This suggests that image quality was a key acceptance criterion and was evaluated through non-clinical means.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Compliance with voluntary standards (AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, IEC 62494-1, DICOM, FDA Guidance for 510(k) for Solid State X-ray Imaging Devices, Radio Frequency Wireless Technology in Medical Devices) | Device conforms to all listed standards and guidance documents. |
| Software changes (memory exposure mode, extended image readout, image compression, battery power-saving designs) evaluated per FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices (moderate level of concern). | Successfully evaluated and verified/validated. |
| Load-bearing characteristics | Tested and passed. |
| Enhanced protection against ingress of water | Tested and passed (increased IPX level). |
| Internal circuit design change for noise reduction | Demonstrated through EMC emission testing per IEC60601-1-2 with satisfactory results. |
| Antibacterial coating safety and effectiveness | Demonstrated through ISO 10993 testing and JIS Z 2801 (equivalent to ISO 22196) testing. |
| Image Quality | Image quality is substantially equivalent to the predicate device (FDR D-EVO DR-ID600, K132509). MTF and DQE measurements are very similar. |
2. Sample size used for the test set and the data provenance:
- Not applicable for clinical data: "No clinical study has been performed."
- For non-clinical tests: The document does not specify sample sizes for the various non-clinical engineering and performance tests (e.g., load-bearing, water ingress, EMC, antibacterial coating). The data provenance is internal to Fujifilm's testing and validation processes.
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):
- Not applicable for clinical data: "No clinical study has been performed." For non-clinical tests, "ground truth" as referred to in a clinical context (expert consensus on disease presence) is not relevant. Engineering standards and specifications served as the "ground truth" for non-clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for clinical data: "No clinical study has been performed."
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, an MRMC comparative effectiveness study was not done. The device itself is a flat panel detector (hardware), not an AI-assisted diagnostic tool. No clinical studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone clinical performance study was done. The device is a digital X-ray detector; it does not operate as an "algorithm only" device in a diagnostic sense. Its standalone performance was evaluated through non-clinical means, primarily engineering tests and comparisons of technical imaging characteristics (MTF, DQE) to a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For non-clinical studies: The "ground truth" for the non-clinical tests was established by adherence to recognized industry standards (e.g., AAMI/ANSI ES60601-1, IEC series, ISO 10993, JIS Z 2801, DICOM), FDA guidance documents, and internal design specifications/requirements verified through engineering testing.
- For clinical studies: Not applicable, as no clinical studies were performed.
8. The sample size for the training set:
- Not applicable: This device is a flat panel detector; it is not described as an AI/machine learning device that would require a "training set" for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable: As the device does not employ machine learning/AI requiring a training set, this question is not relevant.
§ 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.