(26 days)
The OEC Elite™ MiniView™ (mobile mini C-Arm) is designed to provide physicians with real time general fluoroscopic visualization of patients of all ages. It is intended to aid physicians and surgeons during diagnostic or therapeutic treatment/surgical procedures of the limbs/extremities and shoulders including, but not limited to, orthopedics and emergency medicine.
The OEC Elite™ MiniView™ is a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment, and surgical procedures of the shoulders, limbs, and extremities. The system consists of a C-arm attached to an image processing workstation. A CsI(TI) -CMOS flat panel detector and the identical X-ray source monoblock are used for image acquisition.
The C-arm supports the high-voltage generator, X-ray tube, X-ray controls, collimator, and the FPD. The C-arm is capable of performing linear (vertical, horizontal, orbital) and rotational motions that allow the user to position the X-Ray imaging components at various angles and distances with respect to the patient extremity anatomy to be imaged. The C and support arm are mechanically balanced allowing for ease of movement and capable of being "locked" in place using an electronically controlled braking system. The workstation is a stable mobile platform that supports the C-arm, image display monitor(s), image processing equipment/software, recording devices, data input/output devices and power control systems.
The primary technology change for the subject device compared to the unmodified predicate OEC Elite MiniView, was to add an optional wireless footswitch which provides identical functionalities as the wired footswitch to control X-ray on and off.
This document describes the 510(k) summary for the GE OEC Elite™ MiniView™ device, which is a mobile fluoroscopic mini C-arm system. The specific change being submitted for review is the addition of an optional wireless footswitch.
Here's an analysis of the provided text to answer your questions regarding acceptance criteria and the study proving the device meets them:
Crucially, this 510(k) submission states that no clinical studies were required to support substantial equivalence due to the nature of the modification (adding a wireless footswitch). Therefore, many of your questions related to clinical study design (sample size, expert ground truth, MRMC studies, standalone performance) will not be applicable or directly answerable from this document.
The primary method of demonstrating device performance and safety for this submission was through non-clinical testing, including design verification and validation, risk management activities, and compliance with recognized standards.
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a modification (wireless footswitch) and relies on non-clinical testing for substantial equivalence, the "acceptance criteria" are primarily related to product safety, effectiveness, and functional equivalence to the wired footswitch and predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance (Summary from Document) |
|---|---|
| Functional Equivalence: The wireless footswitch provides identical functionalities to the wired footswitch for controlling X-ray on/off. | The wireless footswitch provides "identical functionalities as the wired footswitch to control X-ray on and off." The "functionalities are identical." |
| Safety: Device operates safely in conjunction with the wireless footswitch. | Developed under GE Healthcare's design controls and quality management system. Risk management activities identified, reviewed, and mitigated potential issues. Mitigations verified and validated. |
| Effectiveness: The addition of the wireless footswitch does not negatively affect the overall safety and effectiveness of the device. | Design verification and validation testing performed confirmed that "the safety and effectiveness of the devices has not been affected." |
| Electromagnetic Compatibility (EMC) & Coexistence: The wireless footswitch operates without causing or being susceptible to electromagnetic interference. | EMC and coexistence testing performed per the FDA "Radio Frequency Wireless Technology in Medical Devices" Guidance (August 14, 2013). Results acceptable. |
| Compliance with Standards: Device meets applicable electrical, safety, and performance standards. | Tested by an NRTL and certified compliant with IEC 60601-1 Ed. 3 series, including IEC60601-2-54 and IEC 60601-2-43. All applicable 21CFR Subchapter J performance standards are met. |
| No New Questions of Safety/Effectiveness: The modification should not introduce new safety or effectiveness concerns. | "The addition of the optional wireless footswitch to the system does not raise new questions on safety and effectiveness." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of clinical data. The "test set" here refers to the device itself and its components undergoing engineering and functional verification/validation testing. This is not a patient-based test set.
- Data Provenance: The testing was conducted internally by GE Hualun Medical Systems Co. Ltd. in Beijing, China, as part of their design control processes. This is prospective engineering and quality assurance testing, not data collected from patients.
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)
- Not applicable. Ground truth in a clinical sense (e.g., disease presence) was not established. The "ground truth" for this engineering submission is functional correctness and safety established by engineering specifications, international standards, and internal quality processes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This was not a human reader adjudication study. The "adjudication" was based on successful completion of predetermined engineering tests and compliance with regulatory standards, as overseen by GE's quality management system.
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. The document explicitly states: "The subject of this premarket submission, OEC Elite MiniView with the addition of the wireless footswitch, did not require clinical studies to support substantial equivalence." This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical imaging system, and the submission is for a hardware control component (wireless footswitch), not a standalone algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" used for this submission is based on engineering specifications, functional requirements, and compliance with recognized industry and electrical safety standards. For example, the footswitch must reliably transmit an "X-ray ON/OFF" signal, and the device must maintain its safety characteristics as per IEC 60601 series standards. This is not a clinical ground truth.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI model, there is no ground truth established for one.
§ 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.