(276 days)
The OEC One ASD mobile C-arm system is designed to provide fluoroscopic and digital spot images of adult and pediatic patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, vascular, critical care, and emergency procedures.
The OEC One ASD 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, neurologic, vascular, 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 a flat panel detector on the top of the C-arm and the X-ray Source assembly at the opposite end.
The OEC One ASD is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allows 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 ASD.
The provided document is a 510(k) Summary of Safety and Effectiveness for the GE Hualun Medical Systems Co. Ltd. OEC One ASD, a mobile C-arm X-ray system. The document focuses on demonstrating substantial equivalence to a predicate device, OEC One (K182626), rather than presenting a study with specific acceptance criteria and detailed device performance results for a new AI/CAD feature.
The submission is for a modification of an existing device, primarily introducing an amorphous silicon (a-Si) flat panel detector as the image receptor and updating some hardware and software components. The changes are stated to enhance device performance and are discussed in terms of their impact on safety and effectiveness, concluding that no new hazards or concerns were raised.
Therefore, the information required for a detailed description of acceptance criteria and a study proving device performance, especially for AI/CAD features, is largely not present in this document. The document centers on demonstrating that the modified device maintains safety and effectiveness and is substantially equivalent to the predicate, rather than detailing a study against specific acceptance criteria for a novel functionality.
However, I can extract the available relevant information and highlight what is missing based on your request.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" in the context of a study demonstrating novel AI/CAD feature performance. Instead, it presents a comparison table of technical specifications between the proposed device (OEC One ASD) and the predicate device (OEC One K182626) to demonstrate substantial equivalence. The "Acceptance Criteria" here are implicitly derived from the predicate's performance and safety profiles.
| Feature / Performance Metric | Predicate Device (OEC One K182626) | Subject Device (OEC One ASD) | Discussion of Differences / Equivalence |
|---|---|---|---|
| Image Receptor | Image Intensifier | 21cm Amorphous Silicon (a-Si) Flat Panel Detector | Substantially Equivalent. Change to enhance device performance. |
| DQE | 65% | 70% (0 lp/mm) | Enhanced DQE, indicating improved image quality. |
| MTF | 45% | 46% (1.0 lp/mm) | Slightly enhanced MTF, indicating improved image quality. |
| Field of View | 9 inch, 6 inch, 4.5 inch | 21 cm, 15 cm, 11 cm | No new hazards or hazard situations. Performance testing indicated effectiveness. |
| Image Matrix Size | 1000x1000 | 1520x1520 | Substantially Equivalent. Driven by detector pixel matrix for higher resolution. |
| Image Shape | Circle | Squircle | Substantially Equivalent. Enhanced viewing area without typically unnecessary corner areas. |
| Anti-scatter Grid | Line Rate: 60 L/cm, Ratio: 10:1, Focal Distance: 100 cm | Line Rate: 74 L/cm, Ratio: 14:1, Focal Distance: 100 cm | Substantially Equivalent. Specification updated based on new image receptor. |
| X-ray Generator | Fluoroscopy: 0.1-4.0 mA | Fluoroscopy: 0.1-8.0 mA | Substantially Equivalent. mA range change for optimized image quality (ABS). No new safety/effectiveness concerns. |
| Digital Spot: 0.2-10.0 mA (100-120V system) | Digital Spot: 2-10.0 mA (100-120V system) | Substantially Equivalent. mA range change for optimized image quality (increasing mA on thin anatomy). No new safety/effectiveness concerns. | |
| Imaging Modes | Digital Spot: Normal Dose, Low Dose | Digital Spot: Normal Dose | Low Dose mode not provided for Digital Spot as high mA exposure ensures quality; similar functionality available via Fluoroscopy. |
| Roadmap: Normal Dose, Low Dose | Removed | Roadmap mode removed based on marketing; similar functionality via peak opacify function on cine. | |
| Imaging Features | Zoom & Roam | Zoom (Live Zoom) & Roam | Improved with Live Zoom during fluoro/cine. |
| N/A | Digital Pen | Added for planning/educational purposes. | |
| Monitor Display | Resolution: 1920x1080 | Resolution: 3840 x 2160 | Substantially Equivalent. Updated to higher resolution due to IT advancement. |
| 8bit image display | 10bit image display | Substantially Equivalent. Better display technology. | |
| Tech View Tablet | OS: Android 5.1 | OS: Android 11.0 | Substantially Equivalent. OS upgraded due to IT advancement. |
| C-Arm Physical Dimensions | Orbital Rotation: 120° (90° underscan /30° overscan) | Orbital Rotation: 150° (95° underscan /55° overscan) | Substantially Equivalent. Larger range for user convenience. |
| Image Storage | 100,000 Images | 150,000 Images | Substantially Equivalent. Driven by IT advancement (more storage). |
| Wireless Printing Module | N/A | Wireless Printing Module | Substantially Equivalent. Not for diagnostic use or device control. No new risks. |
| Video Distributor | DVI, BNC | DP, BNC | Substantially Equivalent. Driven by IT advancement. |
| Laser Aimer | Red Laser, Class IIIa/3R, 650 nm, ≤ 5.0 mW | Green Laser, Class 2, 510-530nm, 1mW | Substantially Equivalent. Updated for green laser and convenience (tube side). Both meet laser product requirements. |
| Image Processing | ADRO (based on CPU) | ADRO (based on GPU) | Substantially Equivalent. GPU for better calculation speed. All other listed image processing functions are the same. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission states, "comparative clinical images were evaluated to demonstrate substantial equivalence for the OEC One ASD compared to the cleared predicate," but no details on the sample size, data provenance (e.g., country of origin, retrospective/prospective nature), or specific evaluation methodology for these clinical images are given.
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 provided in the document. The document states that "comparative clinical images were evaluated," but it does not specify the number or qualifications of experts involved in this evaluation or the establishment of ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. The method used to resolve discrepancies or establish a consensus for the evaluation of comparative clinical images is not described.
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
A multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not mentioned or described in this 510(k) submission. The document discusses device modifications and their impact on image quality and functionality, but not the comparative effectiveness of human readers utilizing AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This submission does not describe a standalone performance study for an AI algorithm. The device itself is an X-ray system, and while it has "Image Processing" features, these are not presented as standalone AI algorithms for diagnostic assistance but rather as integrated components affecting image generation and display characteristics. The update to ADRO from CPU to GPU based processing is noted for speed, but its standalone performance as an AI algorithm is not evaluated or presented.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions "comparative clinical images were evaluated," but it does not specify the type of ground truth against which these images were assessed. Since the primary focus is on demonstrating substantial equivalence of technical image characteristics rather than validating a diagnostic AI output, a traditional "ground truth" (like pathology or outcomes a specific AI would predict) is not explicitly detailed. The implicit ground truth would be the expected imaging performance and diagnostic utility comparable to the predicate device.
8. The sample size for the training set
This information is not provided in the document. The document describes modifications to an existing X-ray system, including software updates. It states, "Its software is based on the architecture, design and code base of the predicate device OEC One (K182626)," and underwent a standard software development lifecycle. There is no mention of a separate "training set" in the context of an AI/CAD algorithm as typically understood for deep learning models.
9. How the ground truth for the training set was established
Since no training set for an AI/CAD algorithm is mentioned (refer to point 8), the method for establishing its ground truth is not applicable/provided in this document.
§ 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.