(77 days)
The ImageTile 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 ImageTile device is a digital image display system. The ImageTile device consists of components to provide high resolution visualization of digital images.
The provided document is a 510(k) summary for the Barco ImageTile Flat Panel Display System, which is a digital image display system. It is a regulatory clearance document from the FDA, not a study report detailing acceptance criteria and performance of a device with AI components or complex algorithms.
Therefore, the input does not contain the information required to answer most of the questions, as it pertains to a display system rather than a diagnostic AI device. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device.
However, I can extract the following limited information:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the context of diagnostic performance or a clinical study for an AI algorithm. It details features and intended use for a display system.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is for a medical display system, not a diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. 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
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of what can be inferred from the document:
- Device Name: ImageTile Flat Panel Display System
- Intended Use: Used in displaying and viewing digital images for review by trained medical practitioners.
- Regulatory Clearance: 510(k) clearance (K023339) on December 23, 2002.
- Predicate Device: Barco NV Display Systems Coronis 3MP Medical Flat Panel Display System (K013922).
- Technological Characteristics: Provides high-resolution visualization of digital images.
The document is a declaration of substantial equivalence for a display device, not a performance study of a diagnostic algorithm.
§ 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).