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The Nio Color 3MP LED Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

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This document is an FDA 510(k) clearance letter for the Nio Color 3MP LED (MDNC-3321) Medical Flat Panel Display System. This is a display device, not an AI/ML algorithm or diagnostic device that performs independent analysis. Therefore, much of the requested information (like performance metrics, sample sizes for test/training sets, expert qualifications, ground truth, and comparative effectiveness studies) is not applicable to this type of device.

The FDA clearance for a medical display system primarily focuses on its technical specifications, conformance to standards, and demonstration that it can accurately display medical images for human review. The "acceptance criteria" here refer to the performance specifications of the display itself, and the "study" would be a technical evaluation demonstrating that the display meets those specifications.

Here's an attempt to answer the applicable parts of your request based on the provided document, and explain why other parts are not relevant:

1. A table of acceptance criteria and the reported device performance

For a medical display, acceptance criteria typically involve electrical, optical, and mechanical performance standards (e.g., luminance, contrast, resolution, uniformity, color accuracy, stability, artifact absence). The provided 510(k) letter does not detail these specific criteria or their measured performance. Such information would be found in the full 510(k) submission, specifically in the sections describing design verification and validation. This letter only states that the device is "substantially equivalent" to a predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. This device is a display, not a diagnostic algorithm that processes clinical data. Its "testing" involves technical measurements of the display's performance, not analysis of medical images in a clinical "test set."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. There is no "ground truth" established by medical experts for a display device in the way there would be for an AI diagnostic tool. The ground truth for a display is its ability to accurately render an image as intended by the input signal.

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

Not applicable. No clinical adjudication is performed for a display device's performance.

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 is not an AI-powered device. An MRMC study is designed to assess the impact of a diagnostic aid (like AI) on physician performance. This device is a display, a fundamental piece of hardware for image viewing.

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

Not applicable. This is a display device, not a standalone algorithm.

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

Not applicable. For a display, the "ground truth" would be related to its adherence to technical display standards and specifications, not clinical outcomes or expert diagnoses.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary based on the provided document:

The provided document is an FDA 510(k) clearance letter for a medical display (Nio Color 3MP LED). It indicates that the device is intended for displaying and viewing digital images (excluding digital mammography) for review by trained medical practitioners. The clearance is based on the device being "substantially equivalent" to a legally marketed predicate device.

For a display device, the "acceptance criteria" and "study" would relate to demonstrating its technical performance characteristics (luminance, resolution, uniformity, color accuracy, stability, etc.) meet established medical display standards. This information is typically found in the technical documentation of the 510(k) submission itself, not in the clearance letter. The questions about clinical performance studies, expert ground truth, training sets, and AI assistance are not relevant to a medical display's regulatory clearance process as described in this document.

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