(67 days)
The OEC Elite mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, 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 angles 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, critical care and emergency procedures.
The OEC Elite comes with four image receptor (detector) options: the choice of 21x21 cm or 31x31 cm (new) Thallium-doped Cesium Iodide Cs] solid state flat panel X-ray detector with Complementary Metal Oxide Semiconductor (CMOS) light imager; or the choice of a 9 inch or 12 inch of the same existing image intensifier as in the OEC 9900 Elite.
This document describes the OEC Elite, a mobile fluoroscopy system. It does not contain information on human performance studies or the establishment of ground truth by expert consensus for evaluating clinical tasks. Instead, it focuses on non-clinical engineering and imaging performance testing against defined metrics.
Here is an analysis based on the provided text, focusing on the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document outlines acceptance criteria based on performance metrics for Solid State X-ray Imaging Devices (SSXI) and compares the OEC Elite to its predicate device, OEC 9900 Elite.
| SSXI Metrics | OEC Elite Performance Compared to Predicate OEC 9900 Elite |
|---|---|
| DQE (Detective Quantum Efficiency) | Improved |
| Dynamic Range | Improved |
| Spatial Resolution (MTF, Limiting Resolution) | Equivalent |
| Temporal Resolution | Equivalent |
| Contrast Resolution | Equivalent |
| Beam Alignment | Equivalent |
| Dose Rate | Equivalent |
| Stability of the device characteristics over time | Equivalent |
| Brightness uniformity | Improved |
| Fluoroscopy Frame Rate | Equivalent |
| Reuse Rate | Equivalent |
2. Sample size used for the test set and the data provenance:
The document refers to "additional engineering bench testing" and "imaging performance evaluation using anthropomorphic phantoms." It does not specify a distinct "test set" in terms of clinical images or patient data, nor does it provide a sample size for such a set. It appears the performance evaluations were conducted on the device itself and phantoms.
The data provenance is through non-clinical testing using anthropomorphic phantoms in a laboratory setting at GE OEC Medical Systems, Inc. (GE Healthcare).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the evaluation was based on non-clinical engineering and imaging performance metrics, primarily using anthropomorphic phantoms and objective measurements. There was no mention of human experts establishing ground truth for a clinical test set in this context.
4. Adjudication method for the test set:
This information is not applicable as there was no clinical test set requiring human adjudication to establish ground truth. The evaluation focused on technical performance metrics against a predicate device.
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:
No MRMC comparative effectiveness study was done. The device described (OEC Elite) is a mobile fluoroscopy system, a medical imaging hardware device, not an AI-powered diagnostic tool that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable in the context of an x-ray imaging system. The OEC Elite is a hardware device that produces images, not an algorithm, and the performance criteria relate to image quality and system functionality, not algorithmic output without human intervention.
7. The type of ground truth used:
The "ground truth" for the non-clinical testing was established by objective measurements of physical performance metrics (e.g., DQE, spatial resolution) on the OEC Elite and compared to the established performance of the predicate device (OEC 9900 Elite) and reference devices. Additionally, compliance with recognized standards (e.g., IEC 60601-1 Ed. 3 series, 21CFR Subchapter J) served as a form of "ground truth" for safety and efficacy.
8. The sample size for the training set:
This information is not applicable. The OEC Elite is a medical imaging hardware system, not a machine learning or AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
This information is not applicable as there was no training set.
§ 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.