(22 days)
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The display may be used in dental applications.
Both the Nio Color 2MP (MDNC-2521) and the Nio Color 3MP (MDNC-3521) are medical computer displays designed for general radiology imaging applications.
The MDNC-3521 model can also be used in dental applications.
The devices can also be used for home reading in radiology.
The MDNC-2521 is a derivative of the MDNC-2221.
The MDNC-3521 is a derivative of the MDNC-3421.
The modified displays are effectively identical to the respective predicate devices except for the following changes:
Updated LCD panel with same resolution and dimensions compared to the respective predicate devices New housing, display stand and internal mechanics, with similar functionality and design principle compared to the respective predicate devices Updated internal electronics boards, with similar functionality and design principle compared to the respective predicate devices Updated firmware, with similar functionality and design principle compared to the respective predicate devices New packaging, with similar functionality and design principle compared to the respective predicate devices or any other Barco diagnostic display Rephrasing of the intended usage environment, because of the evolution towards more home reading in radiology Small update in the intended user description The modified device has the following similarities compared to the unmodified device: The same intended use The same operating principle The same fundamental technology
The displays can be used optionally with QAWeb Enterprise software, listed under D332294 as a class 1 device with product code LHO. QAWeb Enterprise is a calibration software that is intended as a quality assurance software for the displays. QAWeb Enterprise software helps to keep the display DICOM compliant.
The display can be used optionally with Intuitive Workflow Tools, cleared in K191845 as a class 2 device with product code PGY. The Intuitive Workflow Tools are accessories for image enhancement on diagnostic displays: SpotView: The Barco SpotView display feature allows focusing on a region of interest in an image by boosting the display's backlight such that the maximum luminance in provided inside the region of interest. SpotView also enables focused observation during reading by dimming images outside the region of interest and increasing the contrast in this region. Also magnification and inversion of pixels are possible with SpotView. AAM - Application Appearance Manager: This workflow tool allows you to set the luminance as well as the color space for each application that is on the workstation. There are often multiple windows open on a screen, but not all of them need the high brightness of the diagnostic applications.
The provided text describes the acceptance criteria and a study demonstrating that the Barco Nio Color 2MP (MDNC-2521) and Nio Color 3MP (MDNC-3521) displays meet these criteria for substantial equivalence to their predicate devices. The study focuses on physical performance bench tests rather than clinical efficacy with AI or human readers.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to predicate devices and the performance bench tests. The Predicate Device columns represent the established performance, which the new devices aim to be substantially equivalent to. The Device for which listing is sought columns show the reported performance of the new devices.
Acceptance Criteria (Implied by Predicate Performance) and Reported Device Performance
| Feature/Test | MDNC-2521 (New Device) Performance | MDNC-2221 (Predicate) Performance | MDNC-3521 (New Device) Performance | MDNC-3421 (Predicate) Performance |
|---|---|---|---|---|
| Common Device Parameters | ||||
| Screen technology | IPS-SFT Color LCD | IPS-Pro | IPS-SFT Color LCD | IPS-TFT Color LCD |
| Active screen size (diagonal) | 541 mm (21.3") | 540 mm (21.3") | 541 mm (21.3") | 540 mm (21.3") |
| Active screen size (HxV) | 433 x 325 mm (17.1 x 12.8") | 432 x 324 mm (17.0 x 12.8") | 433 x 325 mm (17.1 x 12.8") | 432 x 324 mm (17.0 x 12.8") |
| Aspect ratio (H:V) | 4:3 | 4:3 | 4:3 | 4:3 |
| Resolution | 2MP (1600 x 1200 pixels) | 2MP (1600 x 1200 pixels) | 3MP (2048 x 1536 pixels) | 3MP (2048 x 1536 pixels) |
| Color imaging | Yes | Yes | Yes | Yes |
| Gray imaging | Yes | Yes | Yes | Yes |
| Bit depth | 30 bit | 30 bit | 30 bit | 30 bit |
| Viewing angle (H, V) | 178° | 178° | 178° | 178° |
| Uniformity Correction | ULT | ULT | ULT | ULT |
| SteadyColor Calibration | Yes (in MXRT Display Controller) | No | Yes (in MXRT Display Controller) | No |
| Ambient Light Compensation (ALC) | Yes, reading room selection | Yes, reading room selection | Yes, reading room selection | Yes, reading room selection |
| Ambient Light Sensor | Yes | Yes | Yes | Yes |
| Front sensor | Yes | Yes | Yes | Yes |
| Maximum luminance (panel typical) | 1000 cd/m² | 800 cd/m² | 1050 cd/m² | 900 cd/m² |
| DICOM calibrated luminance | 600 Cd/m² | 500 cd/m² | 600 Cd/m² | 500 cd/m² |
| Contrast ratio (panel typical) | 2000:1 | 1400:1 | 2000:1 | 1400:1 |
| Response time ((Tr+Tf)/2) (typical) | 12 ms[*] | 10 ms | 12 ms[*] | 20 ms |
| Housing color | Black (RAL 9004) / White (RAL 9003) | RAL 9003 / RAL 9004 | Black (RAL 9004) / White (RAL 9003) | RAL 9003 / RAL 9004 |
| Video input signals | 2x DisplayPort 1.4 | 1x DVI, 1x DisplayPort | 2x DisplayPort 1.4 | DVI-D Dual Link, DisplayPort |
| USB ports | 2x USB-B 2.0 upstream, 5x USB-A 2.0 downstream | 1x USB 2.0 upstream, 2x USB 2.0 downstream | 2x USB-B 2.0 upstream, 5x USB-A 2.0 downstream | 1x USB 2.0 upstream, 3x USB 2.0 downstream |
| Power rating | 24 VDC, 4 A | 24 VDC, 3.75 A | 24 VDC, 4 A | 24 VDC, 4 A |
| Power consumption | 37 W (nominal) | 50 W (nominal) | 45 W (nominal) | 50 W (nominal) |
| Operating temperature | 0 °C to 35 °C (20 °C to 30 °C within specs) | 0 °C to 35 °C (15 °C to 30 °C within specs) | 0 °C to 35 °C (20 °C to 30 °C within specs) | 0 °C to 40 °C (15 °C to 35 °C within specs) |
| Storage temperature | -20 °C to 60 °C | -20 °C to 60 °C | -20 °C to 60 °C | -20 °C to 60 °C |
| Operating humidity | 8% to 80% (non-condensing) | 8 % to 80 % (non-condensing) | 8% to 80% (non-condensing) | 8 % to 80 % (non-condensing) |
| Storage humidity | 5% to 85% (non-condensing) | 5% to 85% (non-condensing) | 5% to 85% (non-condensing) | 5% to 85% (non-condensing) |
| Minimum operating pressure | 70 kPa minimum | 70 kPa minimum | 70 kPa minimum | 70 kPa minimum |
| Storage pressure | 50 to 106 kPa | 50 to 106 kPa | 50 to 106 kPa | 50 to 106 kPa |
| Bench Tests | ||||
| Spatial resolution – MTF | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Pixel defects, Artifacts | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Temporal Response | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Maximum and Minimum Luminance | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Luminance response, Conformance to DICOM GSDF | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Angular Dependency of Luminance | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Luminance uniformity | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Reflection coefficient | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Veiling glare or small-spot contrast | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| Color tracking | Similar characteristics | N/A (implied by predicate) | Similar characteristics | N/A (implied by predicate) |
| EMC and Safety standards | Compliant | N/A (implied by predicate) | Compliant | N/A (implied by predicate) |
Note: "Similar characteristics" is the conclusion of the bench tests as stated in the document.
[] The intrinsic response time of the new LCD panel on the modified device is further improved with Barco's RapidFrame technology, a proprietary medical overdrive algorithm which improves the temporal response of the system.*
2. Sample Size Used for the Test Set and Data Provenance
The study described is a series of physical performance bench tests conducted on the device itself and in comparison to predicate devices, rather than a study involving medical images or patient data.
- Sample Size for Test Set: Not applicable in the context of clinical images/data. The tests were performed on the modified devices (MDNC-2521 and MDNC-3521).
- Data Provenance: Not applicable. The "data" here refers to the physical performance measurements of the display hardware.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The ground truth for display performance parameters (e.g., luminance, resolution) is established by metrology standards and measurement equipment, not by human expert opinion in this context.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Physical performance measurements do not inherently require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on device characteristics and substantial equivalence to existing predicate devices based on physical performance.
- Effect Size: Not applicable as no MRMC study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done
- Standalone Performance: Not applicable. The device is a medical computer display, and its performance is assessed based on its physical properties and adherence to display standards, not as an AI algorithm. While it can be optionally used with software like QAWeb Enterprise for calibration and Intuitive Workflow Tools for image enhancement, the submission focuses on the display hardware itself.
7. The Type of Ground Truth Used
The ground truth for this device's evaluation is based on physical measurement standards and the performance specifications of the predicate devices. The "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (issued in 2022) serves as the reference for the physical laboratory testing instructions, which define the expected performance characteristics.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a hardware device (display) and not an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As this is not an AI algorithm, there is no training set or ground truth established for training purposes.
§ 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).