(72 days)
The OEC Elite mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include orthopedic, gastrointestinal, endoscopic, urologic, vascular, critical care, and emergency procedures.
The OEC Elite is a Mobile Fluoroscopic C-arm Imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic X-Ray images during diagnostic, interventional, and surgical procedures. These images help the physician visualize the patient's anatomy and interventional tools. This visualization helps to localize clinical regions of interest and pathology. The images provide real-time visualization and records of pre-procedure anatomy, in vivo-clinical activity and post-procedure outcomes. The system is composed of two primary physical components. The first is referred to as the "C - Arm" because of its "C" shaped image gantry; the second is referred to as the "Workstation", which is the primary interface for the user to interact with the system.
The provided document describes the OEC Elite mobile fluoroscopy system, which is a medical imaging device. The document is submitted as a 510(k) premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
However, the document specifically states: "Clinical images are not required to demonstrate the substantial equivalence to the predicate device." This means that there was no clinical study involving human patients or human readers performed to prove the device meets acceptance criteria related to clinical performance (e.g., diagnostic accuracy, reader improvement with AI assistance).
The acceptance criteria and proof of performance are based on non-clinical testing (engineering bench testing and phantom studies).
Here's a breakdown of the requested information based on the provided text, while acknowledging the absence of a clinical study:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):
The acceptance criteria are implied by compliance with various industry standards and guidance documents for X-ray imaging devices. The document asserts that the device met these criteria.
| Acceptance Criteria Category (Implied) | Specific Metrics (Examples from SSXI guidance) | Reported Device Performance |
|---|---|---|
| System Performance | - Risk Analysis | Met design input and user needs; successful verification and validation |
| - Hazard Mitigation | Successfully executed | |
| - Compliance to IEC 60601-1 Ed. 3 series | Compliant | |
| - Compliance to IEC 60601-2-54 | Compliant | |
| - Compliance to IEC 60601-2-43 | Compliant | |
| - Compliance to 21 CFR Subchapter J performance standards | All applicable standards met | |
| Image Quality/Performance | - DOE (Detective Quantum Efficiency) | Acceptable results; identical performance to predicate |
| - Dynamic Range | Acceptable results; identical performance to predicate | |
| - Spatial Resolution (MTF, Limiting Resolution) | Acceptable results; identical performance to predicate | |
| - Temporal Resolution | Acceptable results; identical performance to predicate | |
| - Contrast Resolution | Acceptable results; identical performance to predicate | |
| - Beam Alignment | Acceptable results; identical performance to predicate | |
| - Dose Rate | Acceptable results; identical performance to predicate | |
| - Stability of device characteristics over time | Acceptable results; identical performance to predicate | |
| - Brightness uniformity | Acceptable results; identical performance to predicate | |
| - Fluoroscopy Frame Rate | Acceptable results; identical performance to predicate | |
| - Reuse Rate | Acceptable results; identical performance to predicate | |
| Software Quality | - Design Controls | Compliant |
| - Risk Management | Compliant | |
| - Software Development Lifecycle Processes (IEC 60324 compliant) | Compliant | |
| Functional Features | - Vascular features (Subtraction, Roadmapping, Digital Cine Pulse, Peak opacification, Cine Recording/playback, etc.) | Implemented and functioning as designed (implied by "built upon existing robust...software architecture") |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set. The document refers to "engineering bench testing" and "imaging performance evaluation using anthropomorphic phantoms." The specific number of phantoms or tests is not provided.
- Data Provenance: Not applicable for clinical data. The tests were performed internally by the manufacturer (GE OEC Medical Systems, Inc.) in Salt Lake City, Utah, USA. The data is from non-clinical sources (bench tests, phantom studies).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. As no clinical study was performed, there were no human experts establishing clinical ground truth for a test set. Ground truth for non-clinical performance (e.g., image quality metrics) is established through engineering and physics measurements against defined standards.
4. Adjudication Method for the Test Set:
- Not applicable, as no clinical study with human readers or AI performance evaluation was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. The document explicitly states: "Clinical images are not required to demonstrate the substantial equivalence to the predicate device." Therefore, no MRMC study to compare human readers with and without AI assistance was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, indirectly, in a non-clinical context. The device itself is an imaging system, not explicitly an "AI algorithm" in the modern sense of a diagnostic AI. However, the performance metrics listed (DOE, spatial resolution, contrast resolution, etc., and the functioning of new software features like subtraction or roadmapping) represent the "standalone" imaging performance of the device, without human interpretation as part of the validation study. The "algorithm" here refers to the underlying image processing and control software of the fluoroscopy system.
7. The Type of Ground Truth Used:
- Engineering specifications, physical measurements, and phantom imaging results. The ground truth for the non-clinical performance was based on:
- Design input specifications.
- Compliance with recognized standards (e.g., IEC 60601 series, FDA's "Information for Industry: X-ray Imaging Devices- Laboratory Image Quality and Dose Assessment, Tests and Standards", "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (SSXI)").
- Measurements obtained from anthropomorphic phantoms that simulate human anatomy, rather than actual patient data or clinical outcomes.
8. The Sample Size for the Training Set:
- Not applicable. This device is a fluoroscopy system, not a machine learning model that undergoes "training" in the typical AI sense. The software development process mentioned (IEC 60324 compliant, design control, risk management) pertains to traditional software engineering, not AI model training with large datasets. The new vascular features were "built upon the existing robust and extensible software architecture."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, for the same reason as point 8.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.