(53 days)
The OEC One™ mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.
The OEC One™ is a mobile C-arm x-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, vascular, neurologic, critical care, and emergency procedures. These images help the physician visualize the patient's anatomy and localize clinical regions of interest. The system consists of a mobile stand with an articulating arm attached to it to support an image display monitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatus that has an image intensifier on the top of the C-arm and the X-ray Source assembly at the opposite end.
The OEC One™ is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) 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 mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock.
The subject device is labelled as OEC One.
The provided text is a 510(k) Premarket Notification Submission for the OEC One with vascular option. This document primarily focuses on establishing substantial equivalence to a predicate device (OEC One, K172700) rather than presenting a detailed study with acceptance criteria for device performance in the context of an AI/algorithm-driven device.
The "device" in this context is an X-ray imaging system (OEC One™ mobile C-arm system), and the changes described are hardware and software modifications to enhance vascular imaging features. It is not an AI or algorithm-only device with specific performance metrics like sensitivity, specificity, or AUC.
Therefore, most of the requested information regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable or cannot be extracted from this document.
However, I can extract information related to the device's technical specifications and the testing performed to demonstrate its safety and effectiveness.
Here is a summary of the information that can be extracted, addressing the closest relevant points:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of numerical acceptance criteria (e.g., sensitivity, specificity) for the device's imaging performance in relation to clinical outcomes. Instead, the acceptance criteria are generally implied by conformance to existing standards and successful completion of various engineering and verification tests. The "reported device performance" refers to the device meeting these design inputs and user needs.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with medical electrical equipment standards | Certified compliant with IEC 60601-1 Ed. 3 series, including IEC60601-2-54:2009 and IEC 60601-2-43:2010. |
| Compliance with radiation performance standards | All applicable 21 CFR Subchapter J performance standards were met. |
| Design inputs and user needs met | Verification and validation executed; results demonstrate the OEC One™ system met the design inputs and user needs. |
| Image quality and dose assessment for fluoroscopy | All image quality/performance testing identified for fluoroscopy in FDA's "Information for Industry: X-ray Imaging Devices- Laboratory Image Quality and Dose Assessment. Tests and Standards" was performed with acceptable results. This included testing using anthropomorphic phantoms. |
| Software documentation requirements for moderate level of concern | Substantial equivalence based on software documentation for a "Moderate" level of concern device. |
| Functional operation of new vascular features | The primary change was to implement vascular features (Subtraction, Roadmap, Peak Opacification, Cine Recording/Playback, Re-registration, Variable Landmarking, Mask Save/Recall, Reference Image Hold) to perform vascular procedures with "easiest workflow and least intervention by the user" and "further enhance the vascular workflows." (Bench testing demonstrated user requirements were met.) |
| Safety and effectiveness | The changes do not introduce any adverse effects nor raise new questions of safety and effectiveness. |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated in terms of patient data. The testing involved "anthropomorphic phantoms" for image performance and various engineering/bench testing for functional validation. These are not "test sets" in the typical sense of a dataset for an AI algorithm.
- Data Provenance: Not applicable as it's not patient data for AI evaluation. The testing was conducted internally at GE Hualun Medical Systems Co., Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth from experts is not mentioned for this type of device evaluation.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There was no expert adjudication process described for the testing performed.
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
- MRMC Study: No. This document describes a C-arm X-ray system, not an AI-assisted diagnostic tool that would typically undergo such a study.
- Effect Size of Human Readers: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is an imaging system; its "performance" is inherently tied to image acquisition and display, which are used by a human operator/physician. The "vascular features" are software enhancements to the imaging workflow, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For image quality, the ground truth was based on physical phantom characteristics and established technical standards (e.g., image resolution, contrast, noise, dose measurements). For functional aspects, it was based on meeting design inputs and user requirements validated through engineering tests. No expert consensus, pathology, or outcomes data were used as "ground truth" for this device's substantial equivalence declaration.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This document does not describe an AI model that requires a training set. The software updates are feature additions and modifications, not learned from a large dataset in the way a deep learning model would be.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable, as there is no mention of an AI model with a 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.