(15 days)
Smart Vessel Analysis (SmartVA) is a software post-processing option for the Advantage Workstation (AW) platform which can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch filming/archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.
SmartVA is a software post-processing package for the Advantage Workstation (AW) platform. It is an additional tool for the analysis of 3D angiography data providing a number of display, measurement and batch filming/archive features to study user-selected vessels which include but are not limited to stenosis analysis, pre/post stent planning procedures and directional vessel tortuosity visualization.
The provided document is a 510(k) summary for the GE Smart Vessel Analysis (Smart VA) Option. This type of document is typically submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to present a full clinical study proving specific performance criteria.
Therefore, the document does not contain the detailed information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or their provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Analysis of the document:
The document focuses on establishing substantial equivalence to existing devices (Advantage Windows 3D with Navigator Option and DLX) based on similar functionalities for 3D angiography data analysis. It highlights features like:
- Display, measurement, and batch filming/archive features.
- Assistance in studying user-selected vessels for stenosis analysis, pre/post stent planning, and directional vessel tortuosity visualization.
Instead of presenting performance metrics, the submission relies on:
- Comparison with Predicate: Stating that "The vessel measurements are similar to DLX and the visualization views of the vessel provided are similar to Advantage Windows 3D with Navigator option."
- Risk Management: Mentioning a risk management plan, software development and validation process, and software verification plan to control potential hazards.
- Image Comparability: Concluding that "This product provides images comparable to the predicate devices."
Conclusion:
Based on the provided text, a comprehensive answer to the request regarding acceptance criteria and a study proving those criteria cannot be formulated because the document does not contain this specific information. The 510(k) summary is designed to demonstrate substantial equivalence, not to detail the clinical validation or performance studies that would typically include the requested data points.
§ 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.