(14 days)
syngo Neuro DSA CT is a dedicated post-processing application which allows removing bone structures from CT Angiography (CTA) data sets of the cerebral vasculature. Bone removal is based on a bone mask created from an additional non enhanced CT (NECT) scan that was three-dimensionally registered to the CTA data set.
Syngo Neuro DSA CT facilitates the diagnosis of the cerebral vasculature by removing interfering bone structures from CTA data. This particularly helps to delineate aneurysms and other vascular diseases in the area of the skull base.
syngo Neuro DSA CT is a dedicated post-processing application which allows removing bone structures from CT Angiography (CTA) data sets of the cerebral vasculature. Bone removal is based on a bone mask created from an additional non enhanced CT (NECT) scan that was three-dimensionally registered to the CTA data set.
The provided text describes the syngo Neuro DSA CT device, its intended use, and its substantial equivalence to predicate devices, but does not contain details about specific acceptance criteria, a study proving those criteria were met, or the methodologies used to establish ground truth or evaluate performance.
Therefore, I cannot provide the requested information. The document focuses on regulatory submission (510(k) summary) rather than a detailed scientific study.
Here's what I can infer from the available text:
- 1. A table of acceptance criteria and the reported device performance: Not available.
- 2. Sample sized used for the test set and the data provenance: Not available.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
- 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 available.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device description ("dedicated post-processing application which allows removing bone structures") suggests it's an algorithm, but specific standalone performance metrics are not given. The comparison is against predicate devices in terms of substantial equivalence, not performance metrics.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available. The document talks about "verification and validation testing" as part of risk management, but doesn't specify the ground truth methodology for this testing.
- 8. The sample size for the training set: Not available.
- 9. How the ground truth for the training set was established: Not available.
The document states that "Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing." This indicates that some testing was performed to ensure safety and effectiveness, but the specifics of that testing (including acceptance criteria, sample sizes, ground truth procedures, and expert involvement) are not detailed in this 510(k) summary.
§ 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.