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510(k) Data Aggregation
(52 days)
Optima XR240amx, AutoGrid
The Optima XR240amx is intended to take exposures utilizing film, computed radiography (CR), or wireless detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
Optima XR240amx is a seff-contained; battery operated mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects). The Optima XR240amx is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room.
The system is indicated for taking radiographic exposures of the skull, spinal column, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.
This device is not intended for mammographic applications.
The Optima XR240amx incorporates AutoGrid, which is an optional image processing software installed as a part of the systems Helix image processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.
The Optima XR240amx with AutoGrid is intended to take exposures, using a wired or remote exposure switch, utilizing film, computed radiography (CR), or cleared wireless radiographic detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
Optima XR240amx with AutoGrid is a self-contained; battery operated mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects).
The Optima XR240amx with AutoGrid system is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room.
The incorporation of AutoGrid software into the Helix Image Processing software on the Optima XR240amx allows the user to improve the image contrast in general radiographic images by reducing the effects of scatter radiation in lieu of incorporating a physical anti-scatter grid onto the cleared wireless detectors.
The system is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.
This device is not intended for mammographic applications.
Here's an analysis of the acceptance criteria and the study conducted for the Optima XR240amx with AutoGrid, based on the provided text:
Device: Optima XR240amx with AutoGrid - an image processing software feature that can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images.
Goal of the Study: To demonstrate that AutoGrid software can achieve image contrast equivalent to that of a physical anti-scatter grid.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a structured table format with corresponding reported performance metrics. Instead, it describes:
- Ability to achieve equivalent image contrast: The core performance goal is to demonstrate that AutoGrid can provide image contrast equivalent to physical anti-scatter grids.
- Scatter reduction: The software's mechanism is to estimate and subtract scatter radiation to improve image quality.
- Strength options: The software offers three strength options (Low, Medium, High) corresponding to physical 6:1, 8:1, and 12:1 ratio grids, respectively.
However, the document states the conclusion regarding device performance:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Achieve image contrast equivalent to a physical anti-scatter grid. | "Bench testing was sufficient to demonstrate that the AutoGrid software can achieve image contrast equivalent to that of a physical anti-scatter grid." |
| "The AutoGrid software that is incorporated into the Helix Image Processing software of the Optima XR240amx can be used in lieu of a physical anti-scatter grid... to improve image contrast in general radiographic images by reducing the effects of scatter radiation. This update to this system does not result in any new potential safety risks, it has the same technological characteristics, and perform as well as the devices currently on the market." | |
| "After analyzing design verification and validation testing on the bench it is the conclusion of GE Healthcare that the Optima XR240amx with AutoGrid to be as safe, as effective, and performance is substantially equivalent to the predicate devices." | |
| Operation with different scatter reduction strengths. | "The AutoGrid software can be configured at three global strength options (Low, Medium, and High). The strength indicates the amount of scatter reduction that will occur during image processing. The Low strength corresponds to the amount of scatter reduction that would occur through using a physical 6:1 ratio grid, Medium a physical 8:1 ratio grid, and High a physical 12:1 ratio grid." |
| Maintain safety and effectiveness. | "Safety testing (Verification)" and "Simulated use testing (Validation)" were performed. "New risks were identified... These risks were reviewed and mitigated... The mitigations were verified and validated as a part of the design verification and validation testing that has been executed with acceptable results." |
| "Design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results." | |
| Compliance with relevant standards (ES60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-54, IEC 62366, PS 3.1 - 3.20 DICOM set (Radiology)). | The modification and its applications "comply with voluntary standards" listing these standards. |
2. Sample Size for the Test Set and Data Provenance
The document states: "The subject of this premarket submission, Optima XR240amx with AutoGrid, did not require clinical studies to support substantial equivalence... Bench testing was sufficient to demonstrate that the AutoGrid software can achieve image contrast equivalent to that of a physical anti-scatter grid."
Therefore, there was no test set of patient data (images) in the traditional clinical sense. The testing was "bench testing," meaning it likely involved controlled experimental setups using phantoms or simulated data, rather than real patient images. The document does not specify the sample size of simulated images or controlled experiments used for this bench testing.
Data Provenance: N/A (as no clinical test set was used). The testing was "bench testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. Since the testing was bench testing and not a clinical study involving human readers or patient images, no experts were used to establish ground truth for a clinical test set.
4. Adjudication Method for the Test Set
N/A. As no clinical test set or human interpretation was involved, no adjudication method was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence... Bench testing was sufficient..."
Therefore, there is no reported effect size of how much human readers improve with AI vs. without AI assistance.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone performance study was done in the form of "bench testing." This testing evaluated the AutoGrid software's ability to achieve image contrast equivalent to a physical anti-scatter grid without human interpretation as part of the primary evaluation. The results of this bench testing were considered sufficient to demonstrate performance.
7. Type of Ground Truth Used
The ground truth for the bench testing was established by physical standards or measurements related to image contrast and scatter radiation reduction, likely derived from the performance characteristics of physical anti-scatter grids (e.g., 6:1, 8:1, 12:1 ratios). The benchmark was the "equivalent" image contrast produced by these physical grids.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning, nor does it specify a sample size for such a set. AutoGrid is described as "image processing software" and its mechanism is to "estimat[e] the scatter radiation within the image, and then subtract[] this scatter estimate from the image." While this could imply some form of algorithm trained on data, the submission focuses on its performance validation through bench testing against existing physical grid benchmarks, rather than detailing an AI/ML training process.
9. How the Ground Truth for the Training Set Was Established
N/A. As no training set is explicitly mentioned or detailed, there is no information on how its ground truth might have been established.
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