(195 days)
The Nio 5MP-21″ is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. The Nio 5MP-21", containing the display MDNG-5121 CB, the software NioWatch and the graphic board BarcoMed Nio, will be marketed as separate device.
Nio 5MP-21" is a display system for medical viewing. It consists of 3 components: MDNG-5121 CB is a 21.3" grayscale LCD display. BarcoMed Nio is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch is a softcopy QA software application for local calibration and QA control. The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.
This submission, K062621, describes the Barco Nio 5MP-21" display system, which is intended for displaying digital images, including digital mammography, for review and analysis by trained medical practitioners. The document states that the device is substantially equivalent to existing predicate devices (Coronis 5MP and MFGD 5421). The submission does not provide specific acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical performance study for an AI/CADe device.
Instead, this 510(k) summary focuses on demonstrating that the new device has "substantially equivalent" technological characteristics, general function, application, and intended use as its predicate devices, and that any differences do not affect safety or efficacy. This is a common approach for display systems where the primary concern is the accurate and consistent rendering of medical images, rather than algorithmic detection or diagnosis.
Therefore, the requested information about acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/CADe systems, is not applicable to this 510(k) submission for a medical display system. The "study" here is essentially a technical comparison and declaration of substantial equivalence to a legally marketed predicate device.
However, based on the information provided, here's how some of your questions can be addressed in the context of this submission:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit "acceptance criteria" and "reported device performance" in the context of clinical accuracy (like sensitivity, specificity, AUC) are not provided for this display system. The acceptance criteria for a display system are typically related to its technical specifications matching or being equivalent to the predicate, ensuring it accurately displays images without introducing errors.
| Acceptance Criteria (Implied from Submission) | Reported Device Performance (from Submission) |
|---|---|
| Technological Characteristics: | |
| - Resolution | - 2560x2048 pixels (for MDNG-5121 CB display) |
| - Shades of Gray/LUT | - 8-bit in, 10-bit out lookup table, providing 256 simultaneous shades of gray (for BarcoMed Nio board) |
| - Display Panel | - Uses the same LCD panel as the predicate device (Coronis 5MP / MFGD 5421) |
| - Software Functionality (QA/Calibration) | - NioWatch software allows setting test patterns, calibrating the display, and viewing display/controller info. (Note: Acknowledged lower functionality compared to predicate's accompanying software, but "basic specifications and functions... are the same" and differences "do not affect safety or efficacy.") |
| General Function/Application: | |
| - Display digital images | - Intended for displaying digital images, including digital mammography. |
| - Review and analysis by medical practitioners | - Stated purpose. |
| Safety and Efficacy: | |
| - No adverse impact on safety or efficacy | - "Any difference between both devices does not affect safety or efficacy." |
| - Does not come into contact with patient | - Device description explicitly states this. |
| - Does not control life-sustaining devices | - Device description explicitly states this. |
| Substantial Equivalence: | - "The Barco Nio 5MP-21" is substantially equivalent to the predicate device, Coronis 5MP." |
- "The Barco MDNG-5121 CB is substantially equivalent to the predicate device, MFGD 5421."
- "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use." |
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 is a medical display system, not an AI/CADe device that processes patient data for diagnostic output requiring a "test set" of images or patient data. The "testing" involves technical verification against specifications and comparison to predicate devices, not a clinical data set.
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. See point 2. Ground truth establishment with experts is relevant for diagnostic or AI/CADe devices, not for a display system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2. No test set requiring expert adjudication is mentioned.
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. This is a display system, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device does not have an algorithm that performs a standalone diagnostic or assistive function in the absence of a human reader.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For a display system, the "ground truth" would relate to its technical performance (e.g., luminance, uniformity, resolution accuracy) against industry standards or the manufacturer's specifications, not clinical outcomes or pathology. This document does not detail specific technical performance testing, but rather relies on substantial equivalence.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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).