(287 days)
The Veo reconstruction option is intended to produce cross-sectional images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial and Helical (Volumetric) acquisitions for all ages.
When used, it allows for an alternate reconstruction method designed to reduce image noise, increase resolution and improve low contrast detectability in images produced using raw Computed Tomography data from GE CT scanners. The Veo reconstruction option can be used to reduce noise in diagnostic images and also to reduce the dose required for routine imaging, including CT scans of the head, chest, abdomen and pelvis. The Veo reconstruction option may also improve the image quality of low dose non-diagnostic Filtered Backprojection images such that they become diagnostic.
Currently, Veo is for use with the Discovery CT750 HD CT Scanner.
The Veo Reconstruction Option is composed of Server hardware and reconstruction software. The Veo reconstruction Server is connected to the CT system's operator console via a dedicated Ethemet connection to receive raw scan data for processing and send back the reconstructed image data when completed. Additionally, some minor changes to the CT system software are made to include functionality for installation and operation of the Veo Reconstruction Option. The option when used with the Discovery CT750 HD system (K081105) is an evolutionary modification and performs as well as or better than the computed tomography devices currently on the market. The product changes are primarily associated with the new reconstruction software and hardware. The Veo Reconstruction Option provides another method for reconstruction to that already provided by the CT system.
The Veo Reconstruction Option is intended for head and whole body CT scans when higher image quality and/or lower dose acquisitions are desired for challenging cases. The GE Veo Reconstruction Option when used with the CT System uses virtually the same materials and identical CT imaging principles as our existing marketed product. Discovery CT750 HD.
The provided document is a 510(k) summary for the GE Veo Reconstruction Option, which is an add-on to existing CT systems. It does not contain a detailed study report with specific acceptance criteria and performance metrics in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device and outlining the intended use and device description.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I elaborate on sample sizes, ground truth establishment, expert qualifications, or multi-reader multi-case studies, as this information is not present in the provided text.
The document states: "The Veo Reconstruction Option when used with a GE CT system is an evolutionary modification and performs as well as or better than the computed tomography devices currently on the market." This suggests that the "acceptance criteria" were likely based on demonstrating that the Veo option did not degrade the performance of the CT system and potentially improved certain aspects like noise reduction, resolution, and low contrast detectability, compared to conventional reconstruction methods. However, specific quantitative acceptance criteria or detailed study results are not provided.
Here's what can be extracted and inferred from the text regarding the study and evaluation, acknowledging the significant gaps in detail:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The submission focuses on demonstrating substantial equivalence rather than reporting specific performance metrics against pre-defined acceptance criteria.
- Inferred Performance Claims (Qualitative):
- Reduce image noise
- Increase resolution
- Improve low contrast detectability
- May improve the image quality of low dose non-diagnostic Filtered Backprojection images such that they become diagnostic.
- Allows for an alternate reconstruction method.
- Performs as well as or better than the computed tomography devices currently on the market.
2. Sample size used for the test set and the data provenance
The document does not specify any sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not mentioned in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not mentioned in the provided text.
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
The document does not describe an MRMC comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The Veo Reconstruction Option is described as a reconstruction method, not specifically an AI algorithm with human-in-the-loop performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as a "reconstruction option" that processes raw CT data. It is implied that the performance of this reconstruction is evaluated in terms of image quality metrics (noise, resolution, low-contrast detectability) rather than a diagnostic algorithm's standalone performance on a specific task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not mentioned in the provided text. Given the focus on image quality parameters (noise, resolution, contrast), the evaluation likely involved quantitative phantom studies and potentially qualitative assessment by experts on clinical images, but the method of establishing ground truth is not detailed.
8. The sample size for the training set
Not mentioned in the provided text. As this is a reconstruction option, the "training set" concept (as typically applied in machine learning) might not be directly applicable in the conventional sense, or if used, it is not disclosed.
9. How the ground truth for the training set was established
Not mentioned in the provided text.
Summary of what the document DOES state regarding the study/evaluation:
- Conclusion about Performance: "The Veo Reconstruction Option when used with a GE CT system is an evolutionary modification and performs as well as or better than the computed tomography devices currently on the market." (Page 3)
- Evaluation Methodology (Implied): The device was "developed under GE's Quality System" and "Functional requirements are demonstrated via testing." (Page 3). The claims around noise reduction, increased resolution, and improved low contrast detectability suggest that these were areas of focus for the testing.
- Relationship to Predicate: "The GE Veo Reconstruction Option when combined with the GE CT system is of comparable type and substantially equivalent to GE Healthcare's currently marketed Computed Tomography X-ray Systems." (Page 3). This "substantial equivalence" is the primary regulatory pathway demonstrated.
- Intended Benefits: The option is "designed to reduce image noise, increase resolution and improve low contrast detectability" and "can be used to reduce noise in diagnostic images and also to reduce the dose required for routine imaging." It "may also improve the image quality of low dose non-diagnostic Filtered Backprojection images such that they become diagnostic." (Page 3)
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.