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The Nio Fusion 4MP 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.

The Nio Fusion 4MP, containing the display MDNC 4130, the software MediCal QAWeb and the graphic board MXRT 2100, will be marketed as separate device.

"The MDNC 4130 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.

The MDNC 4130, which is part of the Nio Fusion 4MP system, will be marketed separately.

MDNC 4130 is a 30" color LCD display for medical viewing. It is combined with MediCal QAWeb, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.

Nio Fusion 4MP is a display system for medical viewing. It consists of 3 components: MDNC 4130 is a 30" color LCD display. MXRT 2100 is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb is a softcopy OA software application for local calibration and QA control.

The provided text describes two medical display devices, the Barco MDNC 4130 and the Barco Nio Fusion 4MP, and their substantial equivalence to predicate devices. However, it does not include detailed acceptance criteria or a study that proves the device meets specific performance criteria.

The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed performance study against explicit acceptance criteria. The common strategy for imaging displays in 510(k) submissions is to demonstrate that the new device has comparable or superior technical characteristics to a previously cleared device, and that these differences do not raise new questions of safety or effectiveness.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not present in the provided document.

Here's an explanation based on the information available:

The submissions describe the intended use for both devices: "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."

The core of both submissions is a comparison to a predicate device.

For the Barco MDNC 4130 (K062905):

• Predicate Device: E-2320 C (510(k) number: K052958)
• Key Differences: Uses a larger LCD panel and modified electric circuits.
• Conclusion: "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference between both devices does not affect safety or efficacy."

For the Barco Nio Fusion 4MP (K062905):

• Predicate Device: Color Nio 2MP (510(k) number: K052958)
• Key Differences: Uses a larger LCD panel and modified electric circuits for the display component (MDNC 4130), a different display controller board (MXRT 2100), and the accompanying software (MediCal QAWeb) has more advanced functionality.
• Conclusion: "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference between both devices does not affect safety or efficacy."

Regarding your specific questions:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence, not a direct performance study against pre-defined acceptance criteria. The information provided highlights technical characteristics like resolution (2560x1600 pixels) and functionality (Single View, DuoView, MediCal QAWeb for calibration and QA), and implies that these meet or exceed the predicate's performance.
2. Sample sized used for the test set and the data provenance: Not applicable as a formal performance study with a test set as you describe was not included. The evaluation is based on comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 medical display system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical display system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of device submission.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summaries demonstrate substantial equivalence by comparing technical specifications and intended use to predicate devices. They do not contain the type of detailed performance study data you've requested for a device that relies on explicit acceptance criteria and clinical validation data.

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