(29 days)
syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners).
An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system.
Resulting images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.
syngo.CT Extended Functionality is a software bundle that offers tools to support special clinical evaluations. The "tools" are represented by the so-called Extensions. syngo.CT Extended Functionality can be used to create advanced visualizations and measurements on clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners or other medical imaging modalities (e.g. MR scanners) by using the Extensions.
I am sorry, but the provided text does not contain any information about specific acceptance criteria, study details (like sample sizes, expert qualifications, or multi-reader multi-case studies), or performance data in the format of a table demonstrating how the device meets acceptance criteria.
The document is a 510(k) summary for the device "syngo.CT Extended Functionality," primarily focusing on:
- Regulatory Information: Product codes, classification, submission details, and FDA correspondence.
- Device Description: Explaining its purpose (advanced visualization tools for medical images) and listing its features/extensions, particularly highlighting modifications from a previous version.
- Comparison to Predicate Device: outlining similarities and differences with a previously cleared device.
- Performance Data (General Statement): It states that "performance tests (Non-clinical test reports) to demonstrate continued conformance with special controls for medical devices containing software" were conducted and that "The results of these tests demonstrate that the subject device performs as intended." It also mentions "Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence." However, it does not provide the specific acceptance criteria, numerical performance data, or details of the study design (e.g., sample sizes, expert ground truth, MRMC study results).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document confirms that testing was done and met acceptance criteria generally, but it lacks the specifics required for your detailed questions.
§ 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.