(123 days)
The OEC 9800 Plus is designed to provide fluoroscopic and spotfilm imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
The Series OEC® 9800 is a System used to assist trained Physicians. The system is used to provide X-Ray images while the Physician performs medical procedure. Images from the system help the Physician to visualize the patients' anatomy. This visualization helps to localize surgical regions of interest and pathology. The images provide real-time visualization and records of pre-surgical anatomy, in vivo-surgical activity and post surgical outcomes.
The system is composed of two primary physical elements. The first is referred to as the "C-Arm" because of its "C" shaped image gantry; the second referred to as the "Workstation" because this is the primary user interface to the system.
The system is used in different surgical procedures. Orthopedic Physicians may use the system to help perform hip replacements and reconstructions of badly fractured bones. Vascular Physicians may use the system to perform blood flow studies. Cardiologists may use the system to help see if there are blockages in some of the key arteries supplying blood to the heart. The procedures that these physicians perform are broadly referred to as "Clinical Applications". The system is controlled and run in a clinical environment.
The system employs X-Rays as its imaging technology. An X-Ray Generator located in the base of the C-Arm creates high voltage. High voltage is carried to the X-Ray tube across a set of cables. The X-Ray tube emits X-Rays that are directed toward the patient under the control of the operator. The Physician defines the desired view for the specific clinical procedure and directs the operator. The X-Rays pass through the patient and are captured by the image intensifier (II). Image intensifier images are captured by a camera and displayed on the image monitor located on the Workstation. The system operator and/or Physician view the images as they are displayed and they may choose to store the images for later review.
In order to perform these procedures different views of the human anatomy are required, so the system is designed with the ability to rotate and translate the C-Arm's image gantry to obtain different viewing angles. In addition since there is variation in thickness and density of the anatomy the operator has the ability to adjust the X-Ray Generator technique, image size and orientation to account for the anatomical differences.
This document, K111551, describes the GE Healthcare Surgery OEC® 9800 / OEC® 9800 Plus, which is a mobile fluoroscopic imaging system. The submission focuses on demonstrating substantial equivalence to a predicate device (K082781 OEC® 9900 Elite) rather than proving performance against specific acceptance criteria for an AI/algorithm-based device.
Therefore, many of the requested details, such as those related to AI algorithm performance testing, ground truth establishment, expert adjudication, and MRMC studies, are not applicable or not provided in this specific 510(k) summary. This is a conventional medical imaging device, not an AI/ML-driven one.
Here's a breakdown of the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present performance in terms of specific, quantifiable acceptance criteria or reported device performance metrics in the way one would for an AI algorithm (e.g., sensitivity, specificity, AUC). Instead, it states:
| Criterion Type | Acceptance Criterion (Implied) | Reported Device Performance/Conclusion |
|---|---|---|
| Safety | Device is safe | "Performance testing included in Section 18 Performance Testing - Bench of this 510(k) demonstrates that the OEC® 9800 / OEC® 9800 Plus is safe." |
| Effectiveness | Device is effective | "...effective and performs in an equivalent manner to the predicate device and in accordance with its labeling." |
| Equivalence | Equivalent to predicate device | "The demonstration of substantial equivalence is based on a comparison of features to the predicate device and an assessment of non-clinical performance data." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Size: Not specified for any specific "test set" in the context of an algorithm. The submission mentions "non-clinical performance data" and "bench testing."
- Data Provenance: Not specified. The data would likely be from laboratory bench tests or phantom studies, as this is a hardware device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a hardware imaging device, not an AI algorithm requiring expert ground truth for classification or detection.
4. Adjudication Method for the Test Set
- Not Applicable. No human-interpreted test set requiring adjudication is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is not mentioned. This type of study is typically done for AI-assisted diagnostic devices to measure human reader performance improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device, not a standalone algorithm.
7. The Type of Ground Truth Used
- Not Applicable in the context of ground truth for an AI algorithm. The "ground truth" for a fluoroscopic system would relate to its physical performance characteristics (e.g., image quality metrics, dose output, spatial resolution, contrast resolution), typically measured through bench testing with phantoms and calibrated instruments, rather than expert consensus or pathology.
8. The Sample Size for the Training Set
- Not Applicable. There is no AI algorithm being described, so there is no training set in this context.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, there's no ground truth establishment for it.
Summary of what IS in the document:
- Device Type: Mobile Fluoroscopic Imaging System (OEC® 9800 / OEC® 9800 Plus).
- Intended Use: "to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures."
- Technology: Employs X-Rays and image intensifiers.
- Substantial Equivalence: Claimed based on comparison of features to predicate device (K082781 OEC® 9900 Elite) and assessment of non-clinical performance data (bench testing).
- Conclusion: "Performance testing... demonstrates that the OEC® 9800 / OEC® 9800 Plus is safe, effective and performs in an equivalent manner to the predicate device and in accordance with its labeling."
This document is a standard 510(k) submission for a conventional medical imaging device, demonstrating safety and effectiveness through substantial equivalence, not through AI/ML performance testing protocols.
§ 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.