(62 days)
The Barco Coronis 3MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The Coronis 3MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
The Coronis 3MP device is a digital image display system
The Barco Coronis 3MP device consists of components to provide high resolution visualization of digital images.
The provided text does not contain detailed information about specific acceptance criteria and the study that proves the device meets these criteria. The document is a 510(k) summary for the Barco Coronis 3MP Medical Flat Panel Display System, a device intended for displaying and viewing digital medical images. It primarily focuses on demonstrating substantial equivalence to a predicate device (Barco NV Display Systems MeDis 5MP2 Dual-Head Medical Diagnostic Display System, K001753).
The text does not provide the following information:
- A table of acceptance criteria and the reported device performance: This level of detail about technical performance metrics and their comparison is absent.
- Sample size used for the test set and the data provenance: There is no mention of a test set, data provenance, or any clinical or technical study outcomes.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set is discussed, this information is not present.
- Adjudication method for the test set: No test set is described, so no adjudication method is mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a display system, not an AI or diagnostic algorithm, so an MRMC study with AI assistance is not applicable and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a display system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is discussed as there is no diagnostic algorithm or study evaluated.
- The sample size for the training set: No training set is applicable or mentioned for a display system.
- How the ground truth for the training set was established: Not applicable.
The document mainly states the device's intended use, classification, and asserts substantial equivalence to a predicate device based on its technological characteristics (high-resolution visualization of digital images). Device performance is implied to be similar to the predicate device, which would have undergone its own clearance process, but specific performance metrics for the Coronis 3MP are not detailed in this summary.
§ 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).