(175 days)
The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient's sitting, standing, or in the prone position. The DigiX FDX System is not meant for mammography. The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.
The DigiX FDX system is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaging. The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted x-ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, x-ray generator, x-ray tube, beam limiting device, and a solid-state image receptor. The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections.
Here's a summary of the acceptance criteria and the study information for the Allengers Medical Systems Limited DigiX FDX device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on substantial equivalence to a predicate device (Siemens Ysio K081722) rather than defining explicit, quantitative acceptance criteria for clinical performance. The "acceptance criteria" can be inferred as meeting or being sufficiently similar to the predicate device in terms of functionality and safety, as well as complying with relevant standards.
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments on Equivalence |
|---|---|---|
| Indications for Use: Essential equivalence in scope of use (skull, chest, abdomen, extremities, pediatric, adult, bariatric, interventions, emergency, not mammography). | Matches predicate. | Essentially the same. No differences in indication or intended use. |
| Mechanical System Travel (Ceiling-mounted X-ray tube suspension): Longitudinal, Transverse, Vertical travel within acceptable range for full patient coverage. | Longitudinal: 300 cm (Predicate: 346 cm) | |
| Transverse: 200 cm (Predicate: 220 cm) | ||
| Vertical: 150 cm (Predicate: 190 cm) | Similar with less travel; provides full patient coverage. Does not affect safety or effectiveness. | |
| Mechanical System Travel (Vertical Bucky Stand): Vertical travel within acceptable range for full patient coverage. | VBSAdv Vertical: 125 cm (Predicate: 145 cm) | |
| VBS M XL Vertical: 162 cm (Predicate: 141 cm) | Similar with less/more travel; provides full patient coverage. | |
| Patient Table Features: Type, travel, locking mechanism, maximum patient capacity. | Matches predicate for several components: 4-way float top, electromagnetic locking. Different models (FloatexXL, Floatex+, Floatex, MobiT 6C, 4C, C) have varying travel limits and weight capacities. | Similar, providing patient positioning. Max patient capacity of 200 kg (440 lbs) lower than predicate's 300 kg (660 lbs) for some models, but "Does not affect safety or effectiveness." |
| X-ray Generator: Kilowatt rating, kV min/max, mA max @ 100kV, APR programming. | Matches predicate. | Same. |
| X-ray Tube: Focal spot sizes, heat units, target angle, target diameter, target material. | Variations in specific models (e.g., Varian G1092 vs. Siemens OPTITOP): |
- G1092: 0.6mm/1.2mm focal spot (Predicate: 0.6mm/1.0mm), 1 MHU (Predicate: 783 kHU), 108 mm target diameter (Predicate: 100 mm).
G292: 0.6mm/1.2mm focal spot (Predicate: 0.6mm/1.0mm), 600 KHU (Same), 12° target angle (Predicate: 16°), 102 mm target diameter (Predicate: 100 mm). | Similar, providing essentially same imaging resolution and higher loading for some G1092 models. Different target angle for G292 provides full coverage at 40" SID. Differences in heat units and target diameter also noted as "similar" or providing higher loading/instantaneous focal spot loading. |
| Beam Limiting Device: Construction, compliance with CFR 21 1020.31, automatic feature. | Matches predicate. | Same. |
| Solid State X-ray Image Detectors: Panel type, active area, pixel pitch, pixel matrix, input scintillator, limiting resolution. | Detectors (e.g., P-E XRPAD 4343F vs. Trixell Pixium 4600): - Active area: 432x432mm (Predicate: 429x429mm).
- Pixel pitch: 100 µm (Predicate: 143 µm).
- Pixel matrix: 4318x4320 (Predicate: 3001x3001).
- Limiting resolution: 5 lp/mm (Predicate: 3.57 lp/mm).
Similar differences for other detector models listed. | Essentially the same imaging area. Provides higher resolution for pixel pitch, pixel matrix, and limiting resolution in most cases, which is considered an improvement and not negatively affecting safety or effectiveness. |
| Viewing Monitors: Size, resolution. | Matches predicate. | Same. |
| Software Features: DICOM 3.0 compatibility, operating system, user interaction, multi-user, image import/export, acquisition device, image interferences, organization, search, storage, database, viewing, measurement, annotation, operations, security, generator control. | Matches predicate for all listed software features. Also uses previously cleared image processing software. | Same. |
| Safety Standards Compliance: | Complies with 21 CFR 1020.30, 21 CFR 1020.31, IEC 60601-1, EN 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, EN ISO 14971, EN 62366, EN 62304. | All applicable standards met. |
| Functional Performance: All system motions, image performance. | All functions met design requirements. Image performance criteria satisfactorily met (details in Section 18 of the original submission, not provided in this extract). | Confirmed. |
| Software/Firmware Functionality: All functions between DROC software and IntegraX firmware. | All functions passed testing criteria. | Confirmed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "It was determined that clinical evaluation was not required as all imaging devices have been previously cleared by the FDA."
Therefore, there was no clinical test set used for this specific 510(k) submission. The evaluation was based on non-clinical testing and substantial equivalence to previously cleared devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was used.
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:
Not applicable. The device is a diagnostic X-ray system, not an AI-powered diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a diagnostic X-ray system, not an algorithm, and its performance is evaluated as a system used by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for clinical ground truth, as no clinical evaluation was performed. For non-clinical performance (image quality, functional testing, safety), the "ground truth" was compliance with design specifications and relevant international standards.
8. The sample size for the training set:
The document does not describe the use of machine learning or AI models that would require a "training set" in the traditional sense. The device is a traditional X-ray system. The component parts, such as solid-state detectors and image processing software, are stated to have been "previously cleared by the FDA" or "tested and evaluated per Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices." Therefore, any implicit training (e.g., for image processing algorithms) would have occurred as part of the development and clearance of those component devices, but details are not provided here for the system submission.
9. How the ground truth for the training set was established:
Not applicable, as no training set for an AI/ML model is described for this device.
§ 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.