(79 days)
The Samsung RAYPAX™ Film Digitizer is a digitizer intended to convert medical images and data into digital signals. The digital data can be stored, communicated. processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
The Samsung Film Digitizer (FD) can be part of the RAYPAX PACS (Picture Archiving and Communication System), or can be a separate device for other manufacturer's PACS. It converts analog films to digitized images in the DICOM (Digital Imaging and Communications in Medicine) Standard 3 compatible files. In addition, FD supports a patient information search, an image information management, digitization, a DICOM file generation, a simple image processing, and DICOM file transferring to other components of the PACS.
This document is a 510(k) summary for the Samsung RAYPAX™ Film Digitizer System. It describes the device's purpose, comparison to a predicate device, and confirms substantial equivalence to legally marketed devices. However, the provided text does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study details
- Standalone performance study details
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document focuses on regulatory compliance and the device's technical characteristics and indications for use, not on a detailed analysis of its performance or the studies conducted to prove its efficacy against specific 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).