(86 days)
Digital Imaging System, Model DigiTREX-X000 is a digital video processing system and is intended to be produced by the radiographic, fluoroscopic, or special procedure systems, excluding mamography.
Digital Imaging System, Model DigiTrex-1000 and DigiTrex-2000 is a digital video processing system.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is an FDA clearance letter for the DigiTrex-1000 and DigiTrex-2000 digital imaging systems, indicating substantial equivalence to a predicate device.
It mentions that the device is cleared based on the information provided in the 510(k) submission and that it passed general controls provisions and compliance with good manufacturing practices. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample size, data provenance, number or qualifications of experts, or adjudication methods for any test set.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used.
- Sample size or ground truth establishment methods for a training set.
To answer your questions, I would need access to the actual 510(k) submission document or a summary thereof, which would contain the study details and acceptance criteria.
§ 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).