(35 days)
The Nio 3MP-21" is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
The E-3621 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
Nio 3MP-21" is a display system for medical viewing. It consists of 3 components: E-3621 is a 21" grayscale LCD display. BarcoMed Nio is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing. 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.
E-3621 is a 21" grayscale LCD display for medical viewing. It is combined with NioWatch, a userfriendly software that allows to optimize the display for DICOM-compliant viewing.
Here's a breakdown of the acceptance criteria and study information for the Barco Nio 3MP-21" and E-3621 display systems, based on the provided 510(k) summary:
It's important to note that this 510(k) pertains to a medical display system, not an AI algorithm. Therefore, many of the typical questions related to AI studies (like sample size for training sets, MRMC studies, or multi-reader performance) are not applicable. The substantial equivalence is demonstrated by comparing the technical characteristics and intended use of the new device to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Acceptance Criteria | Barco Nio 3MP-21" (New Device) | Barco E-3621 (New Device) | Predicate Device: Nio 2MP Medical flat panel display system (K042660) | Predicate Device: MFGD 2320 20-inch 2 Megapixel grayscale display (K033004) |
|---|---|---|---|---|
| Intended Use | Displaying and viewing digital images for review by trained medical practitioners. Not for primary image diagnosis in mammography. | Displaying and viewing digital images for review by trained medical practitioners. Not for primary image diagnosis in mammography. | Displaying and viewing digital images for review by trained medical practitioners. Not for primary image diagnosis in mammography. | Displaying and viewing digital images for review by trained medical practitioners. Not for primary image diagnosis in mammography. |
| Components | 3-megapixel flat panel display (E-3621), 10-bit display controller (BarcoMed Nio board), NioWatch software | 21" grayscale LCD display (standalone, combined with NioWatch software) | 2-megapixel flat panel display, display controller, NioWatch software | 20-inch 2 Megapixel grayscale display |
| Display Resolution | 2048x1536 pixels (3MP) | 2048x1536 pixels (3MP) | 2MP (specific resolution not detailed in summary, but assumed lower than 3MP) | 2 Megapixel (specific resolution not detailed in summary, but assumed lower than 3MP) |
| Screen Size | 21" | 21" | Not specified, but implied to be smaller than 21" with "2MP" | 20-inch |
| Lookup Table (Controller) | 8-bit in, 10-bit out, 256 simultaneous shades of gray | Not applicable (standalone display) | 8-bit in, 10-bit out, 256 simultaneous shades of gray | Not applicable (standalone display) |
| Software | NioWatch (optimizes for DICOM, sets display function, test patterns, calibrates, views info) | NioWatch (optimizes for DICOM, sets display function, test patterns, calibrates, views info) | NioWatch | NioWatch |
| Contact with Patient | No | No | No | No |
| Control Life Sustaining Devices | No | No | No | No |
| Backlight Sensor | Yes (part of E-3621 component) | Yes | Not specified (implied to have a front sensor for predicate MFGD 2320) | Assumed to have a front sensor, based on new device having a backlight sensor instead of a front sensor. |
| Technological Characteristics | "Substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference... does not affect safety or efficacy." | "Substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference... does not affect safety or efficacy." |
2. Sample Size Used for the Test Set and Data Provenance
- This 510(k) is for a medical display system, not an AI algorithm performing diagnostic tasks on medical images. Therefore, there is no "test set" of medical images in the sense of a diagnostic performance study.
- The evaluation focuses on the technical specifications and performance of the display hardware and associated software. Data provenance would refer to internal testing and validation of display parameters (e.g., luminance, uniformity, DICOM conformance), which are not detailed in the summary but are standard manufacturer practices for such devices. The origin of such internal data is implicitly from the manufacturer (Barco NV) in Belgium.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable. There is no diagnostic "ground truth" established by medical experts for this type of device. The ground truth for display performance would be established through engineering specifications and industry standards (e.g., DICOM Part 14 calibration).
4. Adjudication Method for the Test Set
- This question is not applicable due to the nature of the device (medical 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 question is not applicable. This is not an AI-assisted diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This is a medical display system, not an algorithm. Its function is to present images for human review.
7. The Type of Ground Truth Used
- The ground truth for this device revolves around its technical specifications meeting established industry standards for medical image display (e.g., DICOM Part 14, NEMA XR 21) and safe operation. The "ground truth" is adherence to performance metrics like resolution, luminance, contrast, uniformity, grayscale reproduction accuracy, and stability over time. These are assessed through technical measurements and quality control procedures, rather than clinical outcomes or pathology.
8. The Sample Size for the Training Set
- This question is not applicable. This is not an AI algorithm.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable. This is not an AI 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).