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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.

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.

1. 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.

2. 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.

3. Adjudication Method for the Test Set:

   • Not applicable. As noted above, the performance metrics of a display are objectively measured.

4. 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.

5. 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.

6. 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.

7. 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.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as no training set was used.

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