(134 days)
The OEC 3D 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, neurologic, vascular, cardiac, critical care, and emergency procedures.
The OEC 3D 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 and volumetric reconstructions 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 major components, a C-Arm and a tethered Workstation. The C-Arm is a stable mobile platform capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral) 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 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. Its functionality is controlled by software on the Workstation and on the OEC Touch, a digital flat panel controller mounted on the cross-arm. 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 Workstation is the primary user interface to the system and can be located at a convenient location in the room independent of where the C-Arm is located.
The provided text describes modifications to the OEC 3D mobile fluoroscopy system, specifically introducing a "3D Spine Centerline Tool with Manual Labeling of the Vertebrae," a "3D Screw Evaluation Tool," and "Augmented Fluoroscopy." The document indicates that these modifications do not require clinical data to establish safety or efficacy and that the device meets acceptance criteria through non-clinical performance testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance/Testing Description |
|---|---|
| 3D Spine Centerline Tool: | Evaluated on cadaveric volume datasets of the spine representing different imaging conditions. The tool identifies vertebrae levels in a 3D volume with centroids and facilitates oblique viewing along the spine centerline defined by the centroids. It also gives the user the option to label vertebrae levels manually. |
| 3D Screw Evaluation Tool: | Evaluated on cadaveric volume datasets of the spine representing different imaging conditions. |
| Augmented Fluoroscopy Accuracy: | Performance testing was done to quantify the error between the projected 3D point of interest on live fluoroscopy (2D X-ray) and its actual position in the associated fluoroscopic image. This testing was conducted using a rigid phantom. |
| General System Performance & Safety: | Successful completion of verification and validation testing as required by design control procedures. Compliant with IEC 60601-1 (including IEC 60601-1-2, 60601-1-3, 60601-2-43, and 60601-2-54), and all applicable 21CFR Subchapter J performance standards (1020.30 Diagnostic X-Ray Systems and their major components, 1020.32 Fluoroscopic equipment, 1040.10 Laser products). Developed under GE OEC Medical Systems Quality Management System, including risk analysis, required reviews, design reviews, unit level testing, integration testing, performance testing, safety testing, and simulated use testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The text states that "cadaveric volume datasets of the spine representing different imaging conditions" were used for the 3D Spine Centerline Tool and 3D Screw Evaluation Tool, and a "rigid phantom" was used for Augmented Fluoroscopy. Specific numbers for the cadaveric datasets or phantom instances are not provided.
- Data Provenance:
- Cadaveric datasets: Implies human cadavers. Country of origin is not specified.
- Rigid phantom: Artificial, not human data.
- Retrospective or Prospective: Not specified, but given the nature of cadaver and phantom studies, they are typically considered controlled experimental setups rather than retrospective or prospective clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not report a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the performance of the device's new features with respect to established metrics (e.g., accuracy for Augmented Fluoroscopy) and demonstrating substantial equivalence to the predicate device through non-clinical testing. It also explicitly states, "The new performance claims did not require clinical data in order to establish safety or efficacy."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The testing described for the "3D Spine Centerline Tool with Labeling" and "3D Screw Evaluation Tool" on cadaveric data, and the "Augmented Fluoroscopy" error quantification with a rigid phantom, suggests standalone performance evaluation of these features. The documentation does not describe a human-in-the-loop study for these features, rather it focuses on the intrinsic performance of the algorithms.
7. Type of Ground Truth Used
- 3D Spine Centerline Tool and 3D Screw Evaluation Tool: The ground truth for these tools was likely established through precise measurements or expert annotations on the cadaveric volume datasets, though the exact method is not detailed.
- Augmented Fluoroscopy: The ground truth for accuracy was established by the known true positions within the rigid phantom, against which the projected 3D points were compared.
8. Sample Size for the Training Set
The document does not specify a sample size for any training set. It primarily discusses validation and verification testing of modifications, which implies the features were developed and potentially trained using internal datasets not detailed in this submission summary.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any training set (if applicable) was established.
§ 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.