(41 days)
The ELIAN diagnostic X-ray system is intended for use on adult and pediatric patients radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. NOT intended for Mammography use.
The ELIAN is a digital radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment. The ELIAN system includes a Detector Panel, Soft Ware, Case, Grid, Power Box, Switch Box, Interconnecting Cables, U-arm Mechanical and Generator. The Detector Panel is an indirect conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Si layer with CSI. The Power Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Flugel SW transfers signals between the Detector and X-ray Generator and also indicates the status of the panel using console. Finally, the Flugel SW contains for image data capture and correction of defects on the image data.
The device in question is the ELIAN Digital Diagnostic X-ray System.
1. Acceptance Criteria and Reported Device Performance
The provided document describes a 510(k) submission for substantial equivalence, focusing on comparative performance against predicate devices rather than specific acceptance criteria for standalone performance. However, some performance metrics are reported.
| Metric | Predicate: CXDI-50G (K031447) | New Device: ELIAN (1717SCC) |
|---|---|---|
| MTF (1lp/mm) | 0.50 | 0.49 |
| MTF (2lp/mm) | 0.22 | 0.234 |
| MTF (3lp/mm) | 0.11 | 0.11 |
| MTF (3.5lp/mm) | N/A | 0.083 |
| DQE(0) | 0.1 | 0.22 |
| DQE(1) | 0.25 | 0.35 |
| DQE(2) | 0.17 | 0.275 |
| DQE(3) | 0.09 | 0.14 |
| Pixel Size | 160 x 160 microns | 127 x 127 microns |
| Dynamic Range | 12 bits | 14 bits |
| Spatial Resolution | 3.1 lp/mm | 3.5 lp/mm |
The document states: "The overall test results conclude that ELIAN has outperformed the predicate device Sedecal X-Plus LP Plus Digital (K090238) in terms of modulation transfer function and detective quantum efficiency."
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical images were provided" but does not specify the sample size for a test set in terms of number of cases or images.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It implies a clinical evaluation, but details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document mentions a "clinical study" that compared diagnostic equivalency but does not specify the number of experts used to establish ground truth or their qualifications. It states, "The result of tests demonstrated that ELIAN produces diagnostic images of equivalent quality as the predicate device..." This implies expert assessment, but no details are provided.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not specifically mentioned or detailed. The document alludes to a clinical study to "investigate the diagnostic equivalency of detector panels," where ELIAN's images were compared to those from a predicate device across eight body parts. However, it does not describe a setup to measure the improvement of human readers with AI assistance. The ELIAN system is an X-ray imaging device, not an AI-powered diagnostic tool for interpretation assistance in MRMC studies.
6. Standalone Performance Study
The primary performance studies mentioned are non-clinical, focusing on physical parameters like MTF and DQE, in accordance with IEC 62220-1:2003 Standard. The document states: "The overall test results conclude that ELIAN has outperformed the predicate device Sedecal X-Plus LP Plus Digital (K090238) in terms of modulation transfer function and detective quantum efficiency." This indicates a standalone algorithm-only (device-only, in this case) performance assessment against a standard and a predicate, particularly for image quality metrics.
7. Type of Ground Truth Used
For the non-clinical testing (MTF, DQE), the "ground truth" is established through physical measurements and standards, specifically IEC 62220-1:2003.
For the clinical study, the "ground truth" used for comparison appears to be the diagnostic images produced by the predicate device, with the goal of showing "equivalent quality." This suggests a comparative diagnostic performance rather than an absolute ground truth (e.g., pathology, outcomes data).
8. Sample Size for the Training Set
The document does not mention a training set sample size. The ELIAN system is described as an image acquisition device, not a machine learning or AI algorithm that typically requires a training set for model development.
9. How the Ground Truth for the Training Set Was Established
Since a training set for an AI algorithm is not mentioned, the method for establishing its ground truth is not applicable/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.