(304 days)
The OEC 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
The OEC® 9800 Plus is a system used to assist trained Surgeons. The system is used to provide X-Ray images while the Surgeon performs a medical procedure. Images from the system help the Surgeon 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 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.
Two printed circuit board assemblies have been combined into a single board in the proposed device due to parts obsolescence. Both the proposed and predicate assemblies share common specifications as confirmed through verification testing.
The proposed device will include a LCD monitor which replaces the obsolete CRT monitor. Both the proposed and predicate assemblies share common specifications as confirmed through verification testing.
The proposed device includes an alternative solid state drive. This drive provides a faster write speed. Both drives meet their specifications.
The proposed device will include a different model of an OEM injector system. Both the proposed and predicate OEM injector systems share common specifications as confirmed through verification testing.
Here's an analysis of the provided text regarding the acceptance criteria and study for the OEC® 9800 Plus, structured according to your request:
Acceptance Criteria and Device Performance
This 510(k) summary primarily describes modifications to an existing fluoroscopic imaging system (OEC® 9800 Plus) rather than a novel device. The core acceptance criteria revolve around demonstrating that the modified components (X-Ray tube, RIU/Image Intensifier, wireless switches, PCBs, LCD monitor, solid state drive, OEM injector system) perform equivalently to the original components and that the overall system maintains its safety, effectiveness, and intended use as the predicate device.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Component Equivalence | Proposed X-Ray tube has same specifications as current supplier's tube. | Verification activities confirmed the proposed tube meets the same specifications. |
| Proposed RIU/Image Intensifier has same specifications as current supplier's RIU. | Verification activities confirmed the alternate RIU meets the same specifications. | |
| Wireless foot switch and hand switch provide identical functionality to predicate's wired versions. | The new option is equivalent to the predicate; functionality is identical. | |
| Combined printed circuit board assemblies maintain common specifications as predicate's separate boards. | Both proposed and predicate assemblies share common specifications as confirmed through verification testing. | |
| LCD monitor maintains common specifications/performance as obsolete CRT monitor. | Both proposed and predicate assemblies share common specifications as confirmed through verification testing. | |
| Alternative solid-state drive meets specifications and provides improved write speed. | Both drives meet their specifications. (Explicitly states faster write speed for the new drive). | |
| Different model of OEM injector system maintains common specifications as predicate's injector. | Both proposed and predicate OEM injector systems share common specifications as confirmed through verification testing. | |
| System Functionality | Maintained X-ray acquisition, X-ray control and indication, patient data management, imaging modes (basic/advanced). | Functional testing performed, including these aspects. |
| Image Quality | Maintained image quality acquisition and assessment, image processing and presentation, screen measurements. | Performance testing included image quality. Proposed device used to produce images evaluated to confirm new monitor met user needs. |
| System Safety & Performance | Overall system mechanical, electrical, and subsystem mechanical tests, and overall system tests are met. | Functional testing performed. |
| User Needs & Intended Use | Device meets user needs and intended uses by simulating a use environment. | Product Simulated Use Testing performed by users with relevant clinical experience. Functional requirements of image storage and recall validated. Images from proposed device evaluated for new monitor. |
| Compliance with Standards | Complies with relevant national and international medical device and radiation safety standards (e.g., 21 CFR 1020.30-32, IEC 60601 series). | The OEC® 9800 Plus complies with the voluntary and mandatory standards listed in Table 1 (e.g., 21 CFR 1020.30-32, UL 60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, NFPA 99, DICOM). |
Study Details:
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Sample sizes used for the test set and the data provenance:
- The document does not specify numerical sample sizes for test sets (e.g., number of images, number of patients, number of devices tested).
- The testing described is primarily retrospective in the sense that the device is a modification to an already cleared product. The testing involved verification and validation of component changes and system performance against established specifications.
- Data provenance: Not explicitly stated as "country of origin for data" in the context of clinical data, as no clinical studies on human patients were performed. The testing seems to be internal to GE Healthcare Surgery, likely performed at their facilities or those of their component suppliers.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "testing performed by users with relevant clinical experience" for the "Product Simulated Use Testing."
- It does not specify the number of experts, nor their specific qualifications (e.g., "Radiologist with 10 years of experience"). It's a general statement about "users with relevant clinical experience."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No formal adjudication method (like 2+1 or 3+1 consensus for image interpretation) is mentioned. This is typical for a 510(k) submission for modifications where the focus is on engineering verification and validation rather than new clinical claims requiring extensive reader studies.
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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 an existing fluoroscopic imaging system, not an AI-powered diagnostic tool. The purpose was to demonstrate equivalence of new components and maintain overall system performance, not to evaluate human reader performance with or without AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is an image-intensified fluoroscopic X-ray system, a hardware and software system for image acquisition and display, not a standalone AI algorithm. The performance evaluated was the system's ability to produce images and function correctly.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For component-level changes, the "ground truth" was the specifications of the predicate device's components. The new components had to match or exceed these specifications.
- For system-level functionality and performance (like image quality, electrical/mechanical tests), the "ground truth" was established engineering design input requirements and established standards (e.g., IEC 60601 series, 21 CFR 1020.30-32).
- For "Product Simulated Use Testing," the "ground truth" for meeting user needs was likely based on the assessment/feedback of "users with relevant clinical experience" against the intended use and established functional requirements.
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The sample size for the training set:
- Not applicable/Not mentioned. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable as there is no training set for an AI algorithm.
§ 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.