(84 days)
The intended use of the DVRS is for viewing, acquiring, archiving and retrieving video images of endoscopic and fluoroscopic procedures. The images may be monochrome or color. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device.
Digital Video Recording System (DVRS)
The provided text discusses regulatory approval for a Digital Video Recording System (DVRS) and its intended use, but it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
The document is a 510(k) clearance letter from the FDA, which signifies that the device is substantially equivalent to a legally marketed predicate device. This process primarily focuses on demonstrating equivalence in terms of safety and effectiveness, rather than presenting a detailed study proving performance against specific acceptance criteria.
Therefore, I cannot provide the requested information. The text does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method.
- Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
- Details about a standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document merely states the intended use of the DVRS for "viewing, acquiring, archiving and retrieving video images of endoscopic and fluoroscopic procedures" and that it is for use by "medical doctors or clinicians such as speech pathologists."
§ 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).