(37 days)
The OEC® 9900 Elite is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, vascular, cardiac, critical care and emergency room procedures.
The OEC® 9900 Elite is a system used to assist trained physicians. The system is used to provide X-Ray images while the physician performs a 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 provided text describes the GE OEC 9900 Elite Mobile Fluoroscopic Imaging System and its 510(k) premarket notification. However, it does not contain information about specific acceptance criteria or a study proving the device meets said criteria in the way typically expected for performance-based medical device submissions (e.g., accuracy, sensitivity, specificity, etc., with detailed statistical analysis).
The submission focuses on establishing substantial equivalence to a predicate device (OEC 9900 Elite, K082781) by stating that the modified device "employs the same fundamental scientific technology" and that "engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or concerns or identify new risks."
Therefore, I cannot fulfill most of your request from the provided text, as the specific details you're asking for are not present.
Here's an attempt to answer based on the available information, highlighting what is not present:
1. A table of acceptance criteria and the reported device performance
- Information Not Provided: The submission does not specify numerical acceptance criteria (e.g., for image quality, resolution, contrast, etc.) nor does it report specific performance metrics against such criteria. The claim is substantial equivalence to a predicate device, implying that the performance is at least as good as the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Information Not Provided: The document does not describe any specific "test set" of patient data or images used for performance evaluation. The "engineering testing and standards compliance testing" mentioned would typically involve technical performance verification (e.g., calibration, image quality phantoms) rather than clinical image interpretation by humans.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Information Not Provided: Since no clinical test set is described, there's no mention of experts or ground truth establishment in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Information Not Provided: No clinical test set or adjudication method is described.
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
- Information Not Provided: This device is a fluoroscopic imaging system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Not Provided: This device is a direct imaging system, not an algorithm. Its performance is inherent to its imaging capabilities, with a human operator (physician or system operator) in the loop during its intended use. It does not have a "standalone algorithm" performance to report.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Information Not Provided: No clinical ground truth is discussed in this submission. The "ground truth" for showing substantial equivalence relies on technical specifications and adherence to standards for the device's components and overall function, compared to the predicate.
8. The sample size for the training set
- Information Not Provided: This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Information Not Provided: This device is not an AI/ML algorithm, so there is no training set or associated ground truth establishment.
Summary based on the provided text:
The GE OEC 9900 Elite Mobile Fluoroscopic Imaging System K120613 submission relies on demonstrating substantial equivalence to a predicate device (OEC 9900 Elite, K082781) rather than presenting a de novo performance study against explicit acceptance criteria.
The key statements regarding performance and safety are:
- "The modified OEC® 9900 Elite device employs the same fundamental scientific technology as the predicate device."
- "Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or concerns or identify new risks."
- "GE Healthcare considers the modified GE OEC® 9900 Elite to be safe, as effective, and performance is substantially equivalent to the predicate device OEC® 9900 Elite (K082781)."
This type of 510(k) submission typically does not include the detailed clinical performance studies, reader studies, or AI algorithm evaluation metrics you requested. The "study" referenced would be the engineering and standards compliance testing that validated the modifications did not alter the fundamental safety or effectiveness demonstrated by the predicate device.
§ 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.