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510(k) Data Aggregation
(30 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 bariatic 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/ supine 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 imaqing.
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 breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document focuses on demonstrating substantial equivalence to predicate devices rather than defining specific quantitative performance metrics as "acceptance criteria" for a new AI/software feature in the way clinical performance studies usually do. Instead, the "acceptance criteria" are implied to be that the modifications do not negatively impact safety or effectiveness, and that the device performs comparably to the predicate devices and meets relevant safety standards.
For the new features explicitly mentioned (Automatic Stitching and Dual Energy Subtraction), the document states they add functionality without affecting patient safety or effectiveness. For the other components, the criteria are often "Same" or "Similar functionality with same imaging results" or "doesn't affect the safety or effectiveness."
To represent this in a table, we'll extract performance comparisons from the "Functional and Specification Differences" table (Table 4) and the "Justification for Differences" (Table 5).
| Feature / Acceptance Criteria | Reported Device Performance (Subject Device: DigiX FDX) | Comparison to Predicate 1 (DigiX FDX K162529) | Comparison to Predicate 2 (Siemens Ysio K081722) | Justification (Implied Acceptance) |
|---|---|---|---|---|
| Clinical Characteristics / Indications for Use | Same as predicate | Same | Same | No new indications for use; no new potential hazards. |
| Mechanical Design (e.g., travel ranges for Ceiling Mounted X-Ray Tube Suspension, Vertical Bucky Stand, Patient Table) | Various models with specified travel ranges (e.g., Longitudinal travel: 300 cm, Transverse travel: 200 cm for CSA FDX) | Mostly "Same as predicate 1" or minor differences with "Similar Functionality" | Differences noted but generally "Same as predicate 1" or "Similar Functionality" | Minor changes do not impact intended use, safety, or effectiveness. |
| Patient Table Maximum Patient Capacity | 250 kg (551 lbs) for FloatexXL, Floatex ADV, MobiT 6C, MobiT 4C; 200 kg (440 lbs) for MobiT C | Increased from 200 kg (440 lbs) for some models | Higher (300 kg for Predicate 2) or NA | Capable of carrying higher patient weight without raising new risks (Note 1). |
| X-Ray Generator (kW rating, kV range, mA max, mAs range, APR programming) | Specified ranges and capabilities (e.g., 65 kW/80 kW, 40-150 kV, 650/800 mA) | "Same" for most parameters; mAs range same as predicate 1 | "Same" for some parameters; mAs range "NS" for predicate 2 | Consistent with predicate devices. |
| IR Remote | Yes (Wireless IR Remote available) | No | NA | New feature, but same functionality as wired hand switch, EMC compliant, meets 21 CFR (Note 3). No new safety/effectiveness issues. |
| X-Ray Tube (Various Varex models: G1092, G292, A292, A192, RAD 14) | Various models with specified focal spots, heat units, target angles, target diameters, target materials. | Mostly "Same as predicate 1" or "Similar Functionality" (e.g., for RAD 14, target diameter different but essentially same imaging results) | Differences noted but generally "Same as predicate 1" or similar. | Already cleared by FDA, essentially same imaging results, do not affect safety or effectiveness (Note 4). |
| Beam Limiting Device (Construction, CFR 211020.31, Automatic) | Multi-leaf, Compliant, Yes | Same | Same | Compliant with standards. |
| Solid State X-Ray Image Detector (Various models from Varex, Thales, IRAY) | Various models with specified panel types, active areas, pixel pitches, pixel matrices, scintillators, limiting resolutions. | Mostly "Same as predicate 1" or "Similar Functionality" or "Same imaging results." | Mostly "Same as predicate 2" or "Similar Functionality" or "Same imaging results." | Previously cleared by FDA, does not raise safety concerns or affect effectiveness (Note 5, 6, 7). |
| Viewing Monitors | 19 inch or more (Touch and Non Touch) | 19 inch Monitor | 19 inch Monitor | Similar functionality, same imaging results, doesn't affect patient safety or effectiveness (Note 8). |
| Software Operating System | Microsoft Windows 7 / Microsoft Window 10 | Microsoft Windows 7 / Microsoft Window 10 | Microsoft Windows 7 | Similar Functionality (Note 9). Updated OS. |
| Automatic Image Stitching (Software Feature) | Automatic | Manual | Manual | New functionality. Software documentation for moderate level of concern included. No new safety/effectiveness issues (Note 9). |
| Dual Energy Subtraction (Software Feature) | Yes | No | No | New feature. Improves radiologist's ability to detect/diagnose chest lesions, makes calcification more conspicuous. Doesn't affect patient safety or effectiveness (Note 10). |
| EMC/Electrical Safety | Compliant with IEC Standards (60601-1, 60601-1-2, 60601-1-3, 60601-2-54, ISO 14971, 62366-1, 62304) | Implicitly comparable | Implicitly comparable | All testing completed and found acceptable. Hazards mitigated. Substantially equivalent to predicate device in safety and effectiveness. |
| Software Level of Concern | Moderate Level of Concern | Moderate Level of Concern (for predicate software DROC K130883) | Moderate Level of Concern (for predicate software DROC K130883) | Software documentation provided per FDA guidance. No new safety/effectiveness issues (Note 9). |
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- "Non-clinical testing included verification and validation testing, image evaluation, testing, and safety testing."
- "Performance testing included functional testing of all motions of the system(s) with respect to the design specifications. Image performance testing was conducted and results included in the submission."
- "Clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system."
The document does NOT specify a sample size for any test set (clinical or otherwise) in terms of patient data or images used for validation of the radiographic system itself, nor does it mention data provenance (country of origin, retrospective/prospective). It primarily relies on hardware and software equivalence, and compliance with industry standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The document explicitly states "Clinical testing is not applicable." Therefore, there was no clinical study conducted that would necessitate expert readers to establish ground truth for a test set. The evaluation focuses on technical performance and equivalence to predicate devices.
4. Adjudication Method for the Test Set
Not applicable. As no clinical test set requiring expert adjudication was performed, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document states "Clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system." Therefore, there is no information on how much human readers improve with or without AI assistance. The new software features (Automatic Stitching, Dual Energy Subtraction) are presented as additional functionalities that don't affect safety or effectiveness, not as AI-assisted diagnostic tools requiring a comparative effectiveness study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The device is a radiographic system, not an AI algorithm intended for standalone diagnostic performance. While it includes new software features (Automatic Stitching, Dual Energy Subtraction), these are integrated functionalities of the imaging system and not described as standalone diagnostic algorithms requiring independent performance evaluation without human interaction.
7. Type of Ground Truth Used
The "ground truth" for the evaluation is primarily based on:
- Compliance with technical specifications and design requirements: Functional testing, image performance testing.
- Adherence to safety and performance standards: IEC 60601 series, EN ISO 14971, IEC 62366-1, IEC 62304, 21 CFR 1020.30, 21 CFR 1020.31.
- Substantial equivalence to predicate devices: Demonstration that the new device has the same intended use, fundamental technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
- Software documentation assessment: For the software components, including the new features, documentation was provided for a "Moderate Level of Concern" software as per FDA guidance.
No clinical ground truth (e.g., expert consensus, pathology, outcomes data) was used or required given the nature of this submission.
8. Sample Size for the Training Set
Not applicable. The document describes an X-ray imaging system, not an AI/ML device that requires a training set of data. The new software features (Automatic Stitching, Dual Energy Subtraction) are described as functionalities, not adaptive algorithms that learn from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there was no training set, there was no ground truth to establish for it.
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