(85 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, vasular, cardiac, 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 C-arm is a stable mobile platform capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allow the user to position the X-Ray image chain at various and distances with respect to the patient anatomy to be imaged. The C - arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock. The C-Arm is comprised of the high voltage generator, software, X-ray control, and a "C" shaped image gantry, which supports an X-ray tube and a Flat Panel Detector or Image Intensifier, depending on the choice of detector configuration desired.
The workstation is a stable mobile platform with an articulating arm supporting a color image, high resolution, LCD display monitor. It also includes image processing equipment/software, recording devices, data input/output devices and power control systems.
The primary purpose of the mobile fluoroscopy system is to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, cardiac, critical care and emergency procedures.
This document (K172550) is a 510(k) summary for a medical device (OEC Elite fluoroscopy system) and does not describe a study related to an AI/ML-based device.
Therefore, many of the requested details, such as "number of experts used to establish ground truth", "adjudication method", "MRMC study", "standalone performance", "training set size", and "ground truth for training set", are completely irrelevant to this document.
The document discusses the substantial equivalence of an updated version of a fluoroscopy system (OEC Elite with Cardiac option) to its predicate device. This is a hardware/software update to an imaging device, not an AI/ML diagnostic or assistive tool.
Based on the provided text, here's what can be extracted regarding acceptance criteria and performance, focusing on the device's performance rather than an AI's performance:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating that the updated OEC Elite with Cardiac option maintains the performance of the predicate device and meets established industry standards for X-ray imaging systems. The "reported device performance" are statements of compliance and successful testing rather than specific numerical results for all metrics.
| Acceptance Criterion (Compliance/Performance Metric) | Reported Device Performance |
|---|---|
| General Compliance/Quality | |
| Design Input and User Needs Met | "Verification and validation, including hazard mitigation has been executed with results demonstrating the OEC Elite mobile fluoroscopy system met design input and user needs." |
| IEC 60601-1 Ed. 3 series compliance (including IEC 60601-2-43) | "The system has been tested and is compliant with the IEC 60601-1 Ed. 3 series, including IEC 60601-2-43." |
| 21CFR Subchapter J performance standards compliance | "All applicable 21CFR Subchapter J performance standards are met." |
| Developed under GE OEC Medical Systems Quality Management System (design controls, risk management, software development) | "The OEC Elite system was developed under the GE OEC Medical Systems Quality Management System, including design controls, risk management and software development life cycle processes." "The changes described above do not change the control mechanism, operating principle, energy type, or intended use from the predicate device." "The substantial equivalence was also based on software documentation for a 'Moderate' level of concern device." |
| Compliance with FDA "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' (SSXI)" | "It was determined the modified system continues to comply to this guidance." |
| Imaging Performance (Identical to predicate OEC Elite) | "All the image quality/performance testing identified for fluoroscopy found in FDA's 'Information for Industry: X-ray Imaging Devices- Laboratory Image Quality and Dose Assessment. Tests and Standards' was performed with acceptable results." "showing identical performance of the subject device to the predicate device OEC Elite." Specific performance aspects mentioned as being evaluated: |
| DOE (Dose Object Eye?) | Not specified numerically, but stated to be in compliance. |
| Dynamic Range | Not specified numerically, but stated to be in compliance. |
| Spatial Resolution (MTF, Limiting Resolution) | Not specified numerically, but stated to be in compliance. |
| Temporal Resolution | Not specified numerically, but stated to be in compliance. |
| Contrast Resolution | Not specified numerically, but stated to be in compliance. |
| Beam Alignment | Not specified numerically, but stated to be in compliance. |
| Dose Rate | Not specified numerically, but stated to be in compliance. |
| Stability of device characteristics over time | Not specified numerically, but stated to be in compliance. |
| Brightness Uniformity | Not specified numerically, but stated to be in compliance. |
| Fluoroscopy Frame Rate | Not specified numerically, but stated to be in compliance. |
| Reuse Rate | Not specified numerically, but stated to be in compliance. |
| Cardiac Profile Performance (Enhancement) | |
| Reduce blooming artifacts, enhance visibility of moving features and vessels with contrast agent (compared to not using profile) | "The Cardiac profile reduces blooming artifacts and enhances the visibility of moving features and vessels filled with a contrast agent when compared to not using the profile." This is a qualitative statement of improvement, not a quantified measurement with acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that no clinical images or human studies were used to demonstrate substantial equivalence for the cardiac option. The testing conducted was "engineering (non-Clinical) testing," "engineering bench testing," and "imaging performance evaluation using anthropomorphic phantoms."
Therefore, there is no "test set" in the sense of clinical patient data, nor is there data provenance (country of origin, retrospective/prospective). The "sample size" would refer to the number of phantom tests or bench tests, which are not specified in numerical terms beyond "successful verification and validation testing" and "additional engineering bench testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. No ground truth was established by human experts for a clinical dataset because no clinical dataset was used for demonstration of substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. 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. This is not an AI device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a fluoroscopy imaging system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's technical performance was established by measurement against established engineering standards and phantom studies, rather than clinical ground truth (e.g., pathology). The "truth" was defined by what parameters an X-ray imaging system should meet.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set" of data. The software changes were built upon an existing architecture and followed a standard software development lifecycle.
9. How the ground truth for the training set was established
Not applicable. No training set was used in the context of AI/ML.
§ 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.