(26 days)
The Wireless/Wired FDR D-EVO III 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 III is not intended for mammography, fluoroscopy, tomography, and angiography applications.
The subject device FDR D-EVO III Flat Panel Detector System (DR-ID1800) is a portable digital detector system that interfaces with, and acquires and digitizes x-ray exposures from, standard radiographic systems. DR-ID1800 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. The software that supports the functions of the FDR D-EVO III Flat Panel Detector System is unchanged from the predicate device, cleared under K142003.
This document describes the FDR D-EVO III Flat Panel Detector System (DR-ID1800) and its substantial equivalence to the predicate device, FDR D-EVO II Flat Panel Detector System (DR-ID1200). The information provided heavily relies on a comparison between the two devices and non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each performance metric. Instead, it relies on demonstrating that the subject device's performance is substantially equivalent to or slightly improved over the predicate device, particularly in areas like DQE. The primary "acceptance criterion" appears to be equivalence through non-clinical testing.
| Metric (Comparison Item) | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (FDR D-EVO III) | Discussion/Conclusion from Document |
|---|---|---|---|
| Indications for Use | Same as predicate | Same as predicate | Same (Except device name) |
| Scintillator | GOS, CsI | GOS only | The subject device has only GOS based detector. No impact on safety or effectiveness of the device. |
| Dimensions | Same as predicate | Same as predicate | Same* |
| Number of Pixels | Same as predicate | Same as predicate | Same* |
| Pixel Size | 150 µm | 150 µm | Same |
| X-ray Conversion | Indirect conversion (a-Si) | Indirect conversion (a-Si) | Same |
| TFT sensor substrate | Glass-based TFT substrate | Film-based TFT substrate | Only the material of substrate is changed, there is no change in the mechanism. No impact on safety or effectiveness of the device. |
| DQE (RQA5, 1 lp/mm, 1mR) - detector alone, without tabletop | 31% (Measurement tolerance ±10%) | 33% (Measurement tolerance ±10%) | Slightly improved DQE by using Film-based TFT substrate. This difference of DQE does not impact clinical Image Quality. |
| MTF (RQA5, 1 lp/mm) | Two options: Normal 60%, High 75% | Two options: Normal 60%, High 75% | Same |
| Appearance | Rounded corners/curved edges, LED/button placement | More rounded shape, changed alignment of LEDs/Operation button that is easier to use | This difference of detector appearance does not impact on safety or effectiveness of the device. |
| Detector Weight | Approx. 2.3kg-3.0kg (14"x17", 17"x17") | Approx. 1.8kg-2.1kg (14"x17", 17"x17") | This difference of detector weight does not impact on safety or effectiveness of the device. |
| Workstation | FDX Console Version 8.0 and above | FDX Console Version 13.0 | This difference of the workstation is only to add this subject detector as the connectable Flat panel detector options. No impact on safety or effectiveness of the device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly states "No clinical study has been performed." Therefore, there is no clinical test set for performance evaluation. Non-clinical studies were performed, but details about sample sizes for those specific tests (e.g., number of detectors tested for DQE) are not provided.
- Data Provenance: The studies are described as "Non-clinical Performance Data." There is no mention of country of origin for any data or whether it was retrospective or prospective, as no human subject data was involved in the substantial equivalence claim.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As "No clinical study has been performed" and no human-reviewed test set is mentioned, this information is not applicable (N/A).
4. Adjudication Method for the Test Set
As "No clinical study has been performed" and no human-reviewed test set is mentioned, this information is not applicable (N/A).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical study has been performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The evaluation focused on the device's technical specifications and imaging capabilities (e.g., DQE, MTF) without human interpretation as the primary endpoint for regulatory submission. The comparison is between the subject device and the predicate device's measured physical characteristics and image quality (as defined by objective metrics). The statement "the image quality evaluation confirmed that the image quality of the FDR D-EVO III Flat Panel Detector System (DR-ID1800) is substantially equivalent to that of the predicate device" refers to objective measurements, not human reader performance.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical studies was established by objective technical measurements and conformity to voluntary standards. This includes:
- Physical measurements of detector characteristics (dimensions, pixel size, weight).
- Quantifiable image quality metrics (DQE, MTF) measured using standardized phantom/test conditions (e.g., RQA5).
- Compliance with various international standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 62304, IEC 62366-1, IEC 62494-1, DICOM).
- Following FDA guidance documents for solid-state X-ray imaging devices and wireless technology.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware component (flat panel detector system), not an AI algorithm. Therefore, there is no training set in the context of machine learning. The "training" for such a device would refer to its design and engineering iterations, not a data-driven training process.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, this is a hardware device, not an AI algorithm requiring a training set.
§ 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.