(56 days)
Reformat Gateway™ is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners). It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware.
Reformat Gateway is a software that receives original data from several devices or PACS system, which reconstructs and sends it to other system automatically. Reformat Gateway reconstructs the thin section slice data into thick section slice data automatically for a fast and routine diagnosis. Also, it generates a MPR reconstructed image automatically according to data specification and distributes original data or reconstructed data to distributed different systems.
The provided text describes the "Reformat Gateway™" software, a Picture Archiving Communications System. However, it does not include detailed acceptance criteria or a specific study proving the device meets performance claims. Instead, it focuses on the substantial equivalence to a predicate device for 510(k) clearance.
Therefore, I cannot populate the table and answer the study-related questions as this information is not present in the provided text.
Here's an explanation of why the information is missing based on the document:
- Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often means showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
- "Validation testing" mentioned, but no details: The text states, "Validation testing was provided that confirms that Reformat Gateway™ performs all input functions, output functions, and all required actions according to the functional requirements specified in the Software Requirements Specification (SRS)." This indicates that some testing was done, but the document does not elaborate on the specific acceptance criteria, the study design, results, or statistical analysis. This level of detail is typically found in a separate validation report, not the 510(k) summary itself.
- "Hazard analysis" mentioned: The submission contains results of a "hazard analysis," classifying potential hazards as "minor," but again, no specifics on how this analysis was conducted or what criteria were used.
Conclusion:
Based on the provided snippets, there is no detailed information about specific acceptance criteria or a study that proves the device meets those criteria in terms of clinical performance, accuracy, or efficacy. The document focuses on regulatory clearance through substantial equivalence.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).