(26 days)
The display is intended to be used in displaying digital images, including standard and multiframe digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
The MDNC-12130 (Nio Fusion 12MP) is a medical computer display designed for both PACS and breast imaging applications. It consists of a 30.9" 12 mega-pixel (4200x2800 resolution) LCD panel with integrated LED backlight. The panel is integrated into the display housing body with an internal mechanics chassis structure, that also integrates the electronics, sensors and power supply. The display module is supported by a display stand. Internal sensors and controllers measure, control and stabilize the device. SoftGlow Lights are integrated as an ancillary function for user comfort and can be lit to illuminate the desk and to create some ambient lighting in the reading room.
This document is a 510(k) Premarket Notification from Barco N.V. to the FDA for their Nio Fusion 12MP (MDNC-12130) display. The document focuses on demonstrating substantial equivalence to a predicate device, the Nio Color 5.8MP (MDNC-6121).
Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are fundamentally based on demonstrating substantial equivalence to a legally marketed predicate device (Nio Color 5.8MP) by showing that the differences in technological characteristics do not raise new questions of safety or effectiveness. The performance testing conducted is to confirm that the new device maintains similar or better performance characteristics compared to the predicate, especially given its specific indication for breast tomosynthesis.
Since this is a medical display, the "performance" is largely about its optical and technical specifications rather than diagnostic accuracy.
| Acceptance Criteria Category | Specific Metric (as per "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology") | Predicate Device (MDNC-6121) Performance | New Device (MDNC-12130) Performance | Result (Met/Not Met/Equivalent) |
|---|---|---|---|---|
| Basic Display Tech | Display Technology | a-Si TFT active matrix LCD with LED backlight | a-Si TFT active matrix LCD with LED backlight | Equivalent |
| Screen Size | Active screen size (diagonal) | 541 mm (21.3") | 784 mm (30.9") | Different (but intended improvement) |
| Active screen size (HxV) | 324.45 x 432.6 mm (12.77" x 17") | 653 x 435 mm (25.7 x 17.1") | Different (but intended improvement) | |
| Resolution | Resolution | 5.8 MP (2100 x 2800 pixels) | Native 12MP (4200 x 2800 pixels), Configurable to 2 x 5.8MP (2100 x 2800 pixels) | Improved (and backwards compatible) |
| Optical Characteristics | Maximum luminance (panel typical) | 1000 Cd/m² | 1200 Cd/m² | Improved |
| DICOM calibrated luminance | 600 Cd/m² | 600 Cd/m² | Equivalent | |
| Contrast ratio (panel typical) | 1400:1 | 1500:1 | Improved | |
| Latency/Response | Frame rate | 60 Hz (60 frames per second) | 60 Hz (60 frames per second) | Equivalent |
| Response time ((Tr + Tf)/2) (typical) Gray-to-gray | 12.5 ms | 10 ms | Improved | |
| Pixel Characteristics | Pixel array | 0.1545 x 0.1545 mm RGB pixel | 0.1554 x 0.1554 mm RGB pixel | Minor difference |
| Pixel pitch | 0.1545 mm | 0.1554 mm | Minor difference | |
| DPI (dots per inch) | 164 | 164 | Equivalent | |
| Subpixel pattern | 0.0515 x 0.1554 mm x 3 (RGB) | 0.0518 x 0.1554 mm x 3 (RGB) | Minor difference | |
| Pixel aperture ratio | 53.6% | 56.5% | Improved | |
| Interface/Calibration | Video input signals | DVI-D Dual Link (2x), DisplayPort (2x) | 2 x DisplayPort 1.2 | Different (modernized) |
| Ambient Light Sensor | Yes | Yes | Equivalent | |
| Luminance calibration and stabilization | Integrated Front sensor with luminance stabilization firmware | Integrated Front sensor with luminance stabilization firmware | Equivalent | |
| QA software | QAWeb | QAWeb | Equivalent | |
| Specific Performance Tests (Qualitative Reporting) | Spatial resolution – MTF | Not explicitly reported for predicate | "similar characteristics" | Met (comparable) |
| Pixel defects, Artifacts | Not explicitly reported for predicate | "similar characteristics" | Met (comparable) | |
| Temporal Response | Not explicitly reported for predicate | "similar characteristics" | Met (comparable) | |
| Maximum and Minimum Luminance, Luminance response | Not explicitly reported for predicate | "similar characteristics" | Met (comparable) | |
| Conformance to DICOM GSDF | Not explicitly reported for predicate | "similar characteristics" | Met (comparable) | |
| Angular Dependency of Luminance | Not explicitly reported for predicate | "similar characteristics" | Met (comparable) | |
| Luminance uniformity | Not explicitly reported for predicate | "similar characteristics" | Met (comparable) | |
| Stability of Luminance and Chromaticity over Time and Operating Temperature | Not explicitly reported for predicate | "similar characteristics" | Met (comparable) | |
| Spatial Noise – NPS | Not explicitly reported for predicate | "similar characteristics" | Met (comparable) | |
| Reflection coefficient - Display Reflectance with Specular, Diffuse & Haze coefficients | Not explicitly reported for predicate | "similar characteristics" | Met (comparable) | |
| Veiling glare or small-spot contrast | Not explicitly reported for predicate | "similar characteristics" | Met (comparable) | |
| Color tracking, Gray tracking | Not explicitly reported for predicate | "similar characteristics" | Met (comparable) |
Study Proving Device Meets Acceptance Criteria:
The study conducted is a bench testing comparison against the predicate device, following the "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology", issued on October 2, 2017.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a quantitative "sample size" in terms of number of devices tested. It refers to "the modified device MDNC-12130" indicating at least one physical unit was tested. For display devices, typically a representative sample or a single unit is tested for performance specifications.
- Data Provenance: The testing was done internally by Barco N.V. (Belgium-based company). The data provenance is physical bench testing of the device itself.
- Retrospective or Prospective: This is a prospective test in the sense that a physical device was manufactured and its performance measured against established standards and the predicate device.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable in this context. The "ground truth" for a display device is its measured physical characteristics (e.g., luminance, resolution, contrast). These are objective measurements performed by specialized equipment, not by human experts creating a ground truth for diagnostic accuracy. The acceptance criteria (e.g., DICOM GSDF conformance) are established standards, not derived from expert consensus on a test set.
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Adjudication Method for the Test Set:
- Not applicable. As noted above, the performance metrics of a display are objectively measured.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was NOT done. The document explicitly states: "No animal testing or clinical testing has been performed." An MRMC study involves human readers interpreting medical images with and without the device/AI assistance; this device is a display, not a diagnostic algorithm. Its function is to accurately render images, which is assessed via technical performance, not diagnostic accuracy by human readers.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was done. The entire "Performance testing" section (point 9 in the 510(k) Summary) describes the engineering bench tests performed on the MDNC-12130 as a standalone device to measure its optical and technical characteristics against the predicate and industry standards.
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The Type of Ground Truth Used:
- The "ground truth" here is based on objective physical measurements and engineering specifications, benchmarked against industry standards (e.g., DICOM GSDF conformance, and the specific metrics outlined in the FDA's "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology"). The predicate device's performance also serves as a comparative "ground" for equivalence.
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The Sample Size for the Training Set:
- Not applicable. This is a hardware display device, not an AI/machine learning algorithm that requires a "training set" of data.
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How the Ground Truth for the Training Set was Established:
- Not applicable, as no training set was used.
§ 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).