(33 days)
The FDR AQRO (DR-XD 1000) is a digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. The FDR AORO is not intended for mammography.
FUJIFILM's FDR AQRO (DR-XD1000) is a compact, economical, lightweight, nonmotorized, low power (2.5 kW), mobile X-ray system designed to work with FUJIFILM's GOS and Csl scintillator FDR D-EVO2 (DR-ID 12XXSE) family of digital X-ray detectors coupled. The D-EVO2 detectors received clearance on 7/23/2014 via 510(k) K142003. The FDR AQRO includes a built-in operation console. The AQRO's console uses Version 10.0 of Fujifilm's FDX Console Software. This software received 510(k) clearance via K170451 on 3/16/2017. The console software includes Virtual Grid 2 (VG2) Image Processing functionality. The VG2 function allows using the mobile X-ray system without a physical grid, resulting in a dose reduction of up to 50% (when compared to using a physical grid). The Virtual Grid 2 Image Processing software received clearance on 4/8/2016 via K153464. The reduction in the external dimensions of FDR AQRO enables smooth movement in the hospital and at the bedside because of an integrated X-ray tube and high-voltage generator (mono-block) that eliminates the need for High Voltage cables and utilizes less space. A high performance Li-ion battery provides up to twelve (12) hours of continuous use (at ~20 exposures/hour) with a quick full charge in four hours. A quick charge of 15 minutes provides one hour of usage. Exposure may also be made when the AC power cord is plugged in.
This document describes the 510(k) premarket notification for the Fujifilm FDR AQRO (DR-XD1000) Mobile X-ray System. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria, comprehensive performance metrics, and a full statistical plan often found in PMA applications or de novo submissions for novel AI/ML devices.
Therefore, many of the typical elements requested in your prompt regarding acceptance criteria and performance studies (e.g., number of experts for ground truth, adjudication methods, MRMC studies, effect sizes, training set details) are not explicitly provided or applicable in this 510(k) summary for a mobile X-ray system. The performance is assessed primarily through non-clinical (phantom images, compliance with standards) and limited clinical data (sample clinical images) to demonstrate that the device is as safe and effective as the predicate.
However, I can extract the information that is present and explain why certain details are missing based on the nature of this submission.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not present "acceptance criteria" in the sense of specific quantitative thresholds for clinical performance (e.g., sensitivity, specificity, AUC) that a novel diagnostic AI algorithm would typically undergo. Instead, the "performance" is demonstrated through:
- Compliance with recognized standards: This serves as a primary form of "acceptance criteria" for safety and basic performance of X-ray systems.
- Comparison to a predicate device: The core argument is substantial equivalence, meaning the new device performs "as safe and effective as" the legally marketed predicate.
- Image Quality: Assessed via sample phantom and clinical images, which are qualitatively evaluated rather than against quantitative metrics in this summary.
- Technical Specifications: Comparison of technical specs to the predicate.
| Acceptance Critera (Implied via Standards Compliance / Equivalence) | Reported Device Performance (FDR AQRO) |
|---|---|
| Safety and Electrical Standards Compliance | Complies with AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, IEC 60601-2-54, IEC 60601-1-3, and IEC 60601-1-6. Also complies with 21 CFR Subchapter J, Electronic Product Radiation Control. |
| Image Quality (General Radiography) | "Acceptable image quality can be obtained with the FDR AQRO despite the smaller values of kV and mAs because of the highly sensitive detector system and the VG2 software." Submission contains sample phantom images and sample clinical images (specific metrics not provided). DQE (GOS): 30% (Predicate: 29%), DQE (CsI): 54% (Predicate: 53%). MTF (GOS): 32% (Predicate: 32%), MTF (CsI): 54% (Predicate: 52%). These values are very similar to the predicate. |
| Functional Equivalence to Predicate | "Even though the subject device is small and compact, it still provides the ability to maneuver and perform all the typical functions required of a mobile x-ray system." "The beam coverage of the subject device is equivalent to the predicate device because the focal spot size is the same as predicate." "Tube arm reach" and "Maximum SID to floor" are comparable to predicate. |
| Software Performance (FDX Console Software) | Fujifilm's FDX Console Software Version 10.0 and Virtual Grid 2 (VG2) Image Processing functionality previously received 510(k) clearance (K170451 for console, K153464 for VG2). VG2 function enables use without a physical grid, potentially reducing dose up to 50%. The associated D-EVO2 detectors were also previously cleared (K142003) and described as having similar MTF and DQE to the D-EVO detectors used with the predicate. |
| Risk Analysis | "As required by the risk analysis, all verification and validation activities for the FDR AQRO were performed and the results were satisfactory." |
| Intended Use | Intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Not intended for mammography. (Predicate had similar indications, albeit without explicit mention of neonatal patients, which the document states does not affect substantial equivalence given the similar technological characteristics). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a quantitative "test set" sample size in terms of number of cases for a clinical performance study. The evaluation appears to involve "sample phantom images" and "sample clinical images" for qualitative assessment. This is typical for a 510(k) for an X-ray system, which focuses on device safety and basic image generation capabilities, rather than a diagnostic algorithm that analyzes images for specific findings.
- Data Provenance: Not specified within this summary. It's likely general radiography data, but no country of origin or whether it's retrospective/prospective is mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable/Not Specified: For a 510(k) submission of an X-ray system, the "ground truth" is typically the physical output and image quality of the device (compared to a predicate and standards), not a diagnostic finding that requires expert interpretation to establish a gold standard. Without a diagnostic study quantifying performance against a true disease state, there's no mention of experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
- Not Applicable/Not Specified: As there isn't a stated clinical study with a test set requiring interpretation for specific findings, there is no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No: The document does not mention an MRMC study comparing human readers with and without AI assistance. This device is an X-ray system, not an AI software for diagnosis. While it includes "Virtual Grid 2" software, its clearance (K153464) and functionality relate to image processing affecting dose and image appearance, not to diagnostic AI assistance for readers that would warrant an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No: This is a physical X-ray system. While it contains software components (FDX Console Software and Virtual Grid 2), the "standalone performance" refers to the system as a whole in generating images, not an AI algorithm analyzing images independently. The performance data is primarily demonstrated through technical specifications, compliance with standards, and visual assessment of sample images.
7. The Type of Ground Truth Used
- Technical Specifications & Compliance Standards/Predicate Comparison: The "ground truth" used for this device is effectively its ability to generate radiographic images safely and effectively, achieving comparable technical performance metrics (e.g., DQE, MTF, tube characteristics, radiation control) to a legally marketed predicate device, and compliance with relevant industry and medical device standards. Qualitative visual assessment of sample phantom and clinical images also contributes.
8. The Sample Size for the Training Set
- Not Applicable/Not Specified: This is not an AI/ML device that learns from a "training set" of images in the conventional sense. It's an X-ray system. The software components like FDX Console and Virtual Grid 2 would have been developed and tested through software validation processes (IEC 62304 compliance is noted), but this does not involve a "training set" of patient images in the way an AI diagnostic algorithm would.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable/Not Specified: Since there is no "training set" for an AI/ML model described, there is no ground truth established in this context. Device performance is evaluated against engineering specifications, safety standards, and equivalence to a predicate.
§ 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.