(80 days)
The Nio 5MP Medical Grayscale Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The Nio 5MP device is a digital image display system. The Barco Nio 5MP device consists of components to provide high resolution visualization of digital images.
This is a 510(k) premarket notification for a medical device: Barco Nio 5MP Medical Grayscale Display System. As such, the submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria and performance metrics typically seen for novel diagnostic algorithms.
Here's an analysis based on the provided text, highlighting the information that is present and noting what is absent:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given text. A 510(k) submission for a display system typically focuses on meeting technical specifications (e.g., luminance, contrast, resolution, DICOM conformance) rather than clinical performance metrics like sensitivity or specificity for a diagnostic task. The document states that the device provides "high resolution visualization of digital images," implying it meets general display standards, but no specific performance criteria or a table are presented.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. Since this is a display system, a "test set" in the context of diagnostic accuracy studies (like those for AI algorithms) is not applicable. The evaluation for a display system would involve technical performance tests and possibly human factor usability assessments, but not a dataset of medical images for diagnostic performance evaluation of the display itself.
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)
This information is not provided. As explained above, the concept of "ground truth" for diagnostic accuracy is not relevant for a medical display system in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Not applicable for a display system.
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
This information is not provided. MRMC studies are used for evaluating diagnostic performance, often for AI algorithms or new imaging modalities. This device is a display system, not an AI diagnostic tool, so such a study would not be performed for its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. Not applicable, as this is a display system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided. Not applicable for a display system.
8. The sample size for the training set
This information is not provided. Not applicable, as this is a display system, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not provided. Not applicable, as this is a display system, not an AI algorithm.
Summary of what is available from the document:
The provided document is a 510(k) Summary for a medical display system. Its primary purpose is to demonstrate substantial equivalence to an already legally marketed predicate device (Barco NV Display Systems Coronis 3MP Medical Flat Panel Display System, K013922).
- Device Description: The Nio 5MP device is a digital image display system consisting of components to provide high-resolution visualization of digital images.
- Intended Use: "The Barco Nio 5MP Display System is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners."
- Basis for Clearance: The FDA's decision to clear the device is based on its determination of "substantial equivalence" to the predicate device, meaning it has the same intended use and similar technological characteristics, or different characteristics that do not raise different questions of safety and effectiveness. The document itself does not contain detailed studies with acceptance criteria for clinical performance but implies that the device meets technical standards necessary for medical image review.
§ 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).