(21 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, neurologic, 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 proposed device will add an alternative supplier for the X-Ray Tube. The current tube and the proposed tube have the same specifications and will be interchangeable. Verification activities confirmed that the proposed tube meets the same specification as the current supplier's tube.
The proposed device will add an alternative supplier for the Radiological Imaging Unit (RIU) or Image Intensifier. The current RIU and the proposed RIU have the same specifications and will be interchangeable. Verification activities confirmed that the alternate RIU meets the same specification as the current supplier's RIU.
The proposed device will provide an optional wireless service platform to allow the user to connect to hospital intranet PACS system. The predicate product features a hard-wired connection. Verification testing confirmed that all specifications, including data security, were met.
Two printed circuit board assemblies have been combined into a single board in the proposed device. Both the proposed and predicate assemblies share common specifications as confirmed through verification testing.
The proposed device will provide an optional wireless foot switch and hand switch. The new option is equivalent to the predicate in that functionality is identical. The wireless option provides placement flexibility and reduced cable clutter.
The provided document is a 510(k) Premarket Notification Submission for the GE OEC 9900 Elite Mobile Fluoroscopic Imaging System. This submission describes modifications to an existing device rather than a new device requiring extensive clinical trials for performance validation. Therefore, the document discusses verification activities to confirm that the modifications meet the same specifications as the predicate device, rather than a study with specific acceptance criteria related to clinical performance metrics like sensitivity, specificity, or reader improvement.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implicitly that the proposed modifications (alternative X-Ray tube, alternative Radiological Imaging Unit (RIU), wireless service platform, combined printed circuit boards, and wireless foot/hand switch) meet the "same specifications" as the current/predicate components and demonstrate "equivalent functionality." The reported device performance is that these criteria were met through verification testing.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Proposed X-Ray tube meets same specifications as current tube. | Verification activities confirmed that the proposed tube meets the same specification. |
| Proposed RIU meets same specifications as current RIU. | Verification activities confirmed that the alternate RIU meets the same specification. |
| Wireless service platform meets all specifications (including data security). | Verification testing confirmed that all specifications, including data security, were met. |
| Combined printed circuit board assemblies share common specifications with predicate. | Confirmed through verification testing. |
| Wireless foot switch and hand switch are equivalent in functionality to predicate. | Verification testing confirmed functionality is identical. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in the context of clinical performance evaluation with patient data. The "verification activities" mentioned are engineering and standards compliance testing, indicating a focus on hardware and software functionality and safety rather than a clinical dataset. Therefore, information about sample size, country of origin, or retrospective/prospective nature of patient data is not provided.
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):
This information is not applicable to the type of study described. The verification testing focused on engineering specifications, not expert interpretation of medical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. There was no clinical test set requiring expert adjudication.
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 study was done. This submission is for modifications to a fluoroscopic imaging system, not an AI-powered diagnostic tool. The focus is on hardware and software equivalence, not human reader performance with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance was evaluated. The device is a "Mobile Fluoroscopic Imaging System," which is an imaging modality, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission was based on engineering specifications and voluntary standards compliance. The verification activities confirmed that the modified components met the established technical requirements and safety standards, which are the "ground truth" for this type of medical device modification.
8. The sample size for the training set:
Not applicable. This submission concerns hardware and software modifications to an existing imaging system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
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.