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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

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.

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The Nio Color 2MP LED Medical Flat Panel Display System 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.

The MDNC-2123 is a derivative of the MDNC-3421. The modifications are:
✓ Change in LCD panel: INX 2MP panel instead of PSD 3MP panel
✓ Change in chassis housing (light-weight design)
✓ Change in packaging (smaller size)
✓ Change in electronics board
✓ Updated firmware

The document provided describes the Barco Nio Color 2MP (MDNC-2123) medical display system and its substantial equivalence to a predicate device (Nio Color 3MP, MDNC-3421). This submission does not involve an AI/ML device, but rather a medical display. Therefore, many of the requested criteria related to AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, and MRMC studies) are not applicable.

Here's an analysis based on the information provided, focusing on what is applicable to a medical display device's validation:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a medical display device typically involve meeting performance specifications relevant to image quality and safety. The document focuses on showing substantial equivalence to a predicate device by comparing technical specifications and performance during bench testing.

The acceptance criteria are implicitly that the differences in technological characteristics of the new device (Nio Color 2MP) do not negatively affect safety or effectiveness compared to the predicate device (Nio Color 3MP) for the stated intended use. Bench testing was performed to demonstrate this.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable. For a medical display device, the evaluation involves bench testing and comparison of technical specifications, not a test set of patient data cases in the way an AI/ML diagnostic algorithm would.
• Data Provenance: Not applicable. The validation involves objective performance measurements of the display hardware and software, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. "Ground truth" in the context of medical displays refers to objective performance metrics (e.g., luminance, resolution, uniformity) measured against industry standards (like DICOM Part 14) and functional requirements, not expert annotations of medical images. These measurements are typically performed by engineers or technicians using specialized equipment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of medical images, which is not part of a medical display's validation as described here.

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 device is a display, not an AI/ML algorithm. MRMC studies are used to evaluate diagnostic performance of AI or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a medical display, which is a display hardware and firmware system. It does not perform diagnostic algorithms in a standalone capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For this device (a medical display), the "ground truth" or reference for performance evaluation would be objective physical and electrical measurements of display characteristics (e.g., luminance, contrast, uniformity, resolution) against established technical standards (e.g., DICOM Part 14 for grayscale display function, IEC standards for electrical safety and EMC).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable. This is not an AI/ML algorithm requiring a training set.

Summary of the Study and Conclusion:

The study performed for the Barco Nio Color 2MP (MDNC-2123) was a bench testing and technical specification comparison to demonstrate substantial equivalence to its predicate device, the Nio Color 3MP (MDNC-3421). The justification for substantial equivalence was based on:

• The devices having the same intended use.
• The technological differences (e.g., different LCD panel, chassis, electronics board, firmware, and resulting changes in resolution, screen size, luminance, etc.) not affecting safety or effectiveness for the intended use.
• Bench testing (PPVR for LCD panel, environmental tests for housing/packaging/electronics, electrical safety, EMC, and firmware tests) confirming that the new device has similar characteristics and introduces no new safety or performance issues.

The acceptance criteria were met by demonstrating that despite the technological variations, the device's performance aligns with safety and effectiveness requirements for medical display systems, and that it is suitable for its stated Indications for Use.

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The NIO 2MP LED Display (MDNC-2221) 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 Color 2MP (MDNC-2221)

The provided text is a 510(k) premarket notification letter from the FDA to Barco N.V. regarding their Nio Color 2MP display. This document does not contain information about the acceptance criteria for a device's performance or a study proving it meets those criteria.

The letter is primarily a regulatory approval document, stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for displaying and viewing digital images by trained medical practitioners (excluding primary image diagnosis in mammography). It outlines the regulatory classification, applicable regulations, and general controls the manufacturer must adhere to.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document because it is not present.

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The Nio Color 2MP (MDNC-2121) is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography

Nio Color 2MP (MDNC-2121)

I am sorry, but the provided context does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical display device (Nio Color 2MP) and outlines its intended use and regulatory classification. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or MRMC studies.

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