(72 days)
The 3D-Angio package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. The 3D-Angio package is intended to assist the physician in diagnosis and treatment of vessel malformations (i.e. aneurysms, AVMs, stenoses), particularly neuro-angiographic cases.
The 3D-Angio package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
This 510(k) summary for the 3D-Angio software option provides very limited information regarding acceptance criteria and performance studies. The document primarily focuses on establishing substantial equivalence to a predicate device based on its technological characteristics and intended use. Therefore, much of the requested information cannot be extracted from the provided text.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria are mentioned in the provided text. The document states that the 3D-Angio software is "substantially equivalent" to the GE Advantage 3D XR, implying that its performance is comparable to that device. However, no specific performance metrics or acceptance criteria for the 3D-Angio itself are presented.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicit criteria provided in the document. | The device "allows construction of a three-dimensional model from images acquired during rotational angiography," which is stated as being comparable to the predicate device. No quantitative performance metrics are given. |
2. Sample size used for the test set and the data provenance
Not mentioned in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not mentioned in the document.
4. Adjudication method for the test set
Not mentioned in the document.
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
Not mentioned in the document. This submission predates the commonality of "AI" as understood today, and the focus is on a software option for 3D reconstruction, not an AI-powered diagnostic tool in the modern sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire device is a "software option," which inherently means it's an algorithm. However, the performance is described in terms of its ability to "assist the physician" implying human interpretation remains central. No specific standalone performance study without human interaction is detailed as an independent evaluation. The performance is implied through its intended use and comparison to a predicate device.
7. The type of ground truth used
Not mentioned in the document. Given the nature of a 3D reconstruction tool, the "ground truth" would likely relate to the accuracy of the 3D model relative to the actual anatomical structures, but no details are provided on how this was assessed.
8. The sample size for the training set
Not mentioned in the document.
9. How the ground truth for the training set was established
Not mentioned in the document.
§ 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.