(153 days)
The OEC Elite MiniView (mobile mini C-Arm) is designed to provide physicians with real time goopic 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 OEC Elite™ MiniView™ is a mobile fluoroscopic mini C-arm system. The provided document is a 510(k) Premarket Notification Submission, which focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria in the typical sense of a clinical trial for a novel AI device. However, based on the information provided, we can extract details about the performance evaluation done to demonstrate this equivalence.
Here's an analysis based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC as one might find for an AI diagnostic algorithm. Instead, the evaluation focuses on demonstrating that the performance of the proposed device (OEC Elite™ MiniView™) is at least equivalent to the predicate device (OEC Mini 6800 Digital Mobile C-arm) and reference devices in terms of image quality and clinical capability.
The "acceptance criteria" here implicitly revolve around ensuring the safety and effectiveness of the updated device, which includes:
- Meeting design input and user needs.
- Compliance with regulatory standards (IEC 60601-1 Ed.3 series, IEC 60601-2-54, IEC 60601-2-43, and 21CFR Subchapter J performance standards).
- Image quality and clinical capability at least equivalent to the predicate device.
| Performance Aspect | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Overall Performance | System meets design input, user needs, and regulatory standards; image quality and clinical capability at least equivalent to predicate. | "The system has been NRTL tested and certified compliant... All applicable 21CFR Subchapter J performance standards are met. The OEC Elite™ MiniView™ system was developed under the GE Healthcare's design controls processes... and additional engineering bench testing was performed... to demonstrate system performance." |
| Image Quality | Image quality metrics (e.g., resolution, noise reduction) are adequate for viewing extremities and are at least equivalent to predicate/reference devices. | Pixel Size: Proposed Device: 100 Microns. (Reference Device: 75 Microns). Reported: "larger for reducing image noise. The resolution is higher than the Image Intensifier on the predicate." |
| Array Size: Proposed Device: 1.3k x 1.3k. Reported: "adequate for viewing extremities." | ||
| Field Size: Proposed Device: Full Field 13 cm circle, Limited Field 10 cm circle. Reported: "appropriate for viewing extremities." | ||
| Clinical Capability | Demonstrated ability to provide fluoroscopic visualization in diagnostic/therapeutic/surgical procedures of limbs/extremities/shoulders equivalently to the predicate. | Cadaver study results: "For all procedures, the study confirmed the clinical capability and overall quality of the images produced by the OEC Elite™ MiniView™ was at least equivalent to that of the Mini 6800 Digital Mobile C-Arm." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions a cadaver study involving two cadavers on which nineteen orthopedic procedures were performed across a variety of extremity anatomies.
- Data Provenance: The cadaver study was performed as part of the submission process, implying it was a prospective evaluation specifically for this device. The country of origin of the cadavers is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Two independent physicians were used to evaluate the images.
- Qualifications of Experts: The document states they were "two independent physicians", and given the nature of the device (fluoroscopic imaging for orthopedic procedures), it's highly probable these were orthopedic surgeons or radiologists with expertise in musculoskeletal imaging and procedures. However, their specific specializations or years of experience are not explicitly stated in the provided text.
4. Adjudication Method for the Test Set
The document states: "The performance of the subject device to the predicate was also performed by two independent physicians." It further states that the "study confirmed the clinical capability and overall quality of the images produced by the OEC Elite™ MiniView™ was at least equivalent to that of the Mini 6800 Digital Mobile C-Arm." This implies a consensus or comparative evaluation by the two physicians. However, a specific adjudication method (e.g., 2+1, 3+1, etc.) is not explicitly detailed. It's presented as a direct comparison where both physicians apparently agreed on the equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Not a typical MRMC study: The evaluation described is not a traditional MRMC comparative effectiveness study focused on quantifying human reader improvement with AI assistance. This device is an imaging system (hardware and software for image acquisition and processing), not an AI-powered diagnostic aide designed to improve human reader performance for a specific task.
- Focus on System Equivalence: The study aimed to demonstrate the system's overall clinical capability and image quality equivalence to a predicate device, as evaluated by human readers (the two physicians), rather than measuring the effect size of AI assistance on human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone "Algorithm" Performance: The device itself is an imaging system, not purely an algorithm. Its performance is inherent in the images it produces. Therefore, "standalone" in this context refers to the system's ability to produce diagnostically acceptable images.
- Bench Testing and Image Quality Tests: The document details extensive "engineering bench testing" and "image quality/performance testing" identified for fluoroscopy. These tests evaluate the system's technical image output without human interpretation as the primary endpoint. This can be considered the equivalent of "standalone" performance for an imaging device. Specifically mentioned are:
- Demonstration of system performance.
- Imaging performance evaluation using anthropomorphic phantoms (including a pediatric anthropomorphic phantom).
- 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.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- For the Cadaver Study (Test Set): The ground truth for evaluating clinical capability and image quality seems to be based on expert consensus (or agreement) between the two independent physicians regarding the equivalence of the images produced by the OEC Elite™ MiniView™ compared to the predicate device for diagnostic and procedural guidance in the cadaveric setting. There is no mention of pathology or outcomes data for this specific evaluation, as it's a technical performance and clinical utility assessment on cadavers.
- For Bench Testing: The ground truth for bench testing and phantom studies would be defined by known physical properties of the phantoms and established engineering specifications and standards for image quality metrics.
8. The Sample Size for the Training Set
The document describes a medical imaging device (C-arm), not an AI algorithm that requires a separate training set. Therefore, the concept of a "training set sample size" as typically applied to machine learning models is not applicable here. The device's underlying technology and software architecture are based on existing, proven designs (predicate and reference devices), with modifications validated through engineering bench tests and the cadaver study.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no explicit "training set" in the context of an AI algorithm described in this document. The device's development involved standard engineering practices, which could be considered an iterative design and testing process that refines the system's performance. The "ground truth" during this development would be based on engineering specifications, performance targets, and established imaging principles, rather than a labeled dataset for training an AI model.
§ 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.