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The MD211G3 gray scale display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.

To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display controllers.

MD211G3 cannot be used for a life-support system.

This device must not be used in digital mammography.

This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.

Medical Display, MD211G3 is a 21.3" Monochrome LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

Here's an analysis of the acceptance criteria and study information for the NEC MD211G3 medical display, based on the provided text:

Acceptance Criteria and Device Performance (Table)

The device, MD211G3, is a medical LCD monitor. The primary "acceptance criteria" discussed are its performance specifications, which are benchmarked against those of its predicate device, the L218TL. The study aims to demonstrate substantial equivalence by meeting these comparable specifications.

Study Details:

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

   • The document does not specify a sample size for image data or specific cases used in performance testing.
   • The testing performed was on the device itself as product, not on a dataset of patient images.
   • Data Provenance: Not applicable in the context of image data. The device itself is manufactured by NEC Display Solutions Ltd. in Japan.

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

   • This information is not provided. The study focuses on technical performance of the monitor, not diagnostic accuracy based on expert interpretation of images displayed on it. The "trained physicians" are mentioned in the intended use, but not as part of the performance testing methodology.

3. Adjudication method for the test set:

   • This information is not provided and is not directly relevant for the type of device (display monitor). The performance testing described refers to meeting technical criteria from AAPM Task Group 18, which would typically involve objective measurements rather than expert adjudication of clinical findings.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This device is a display monitor, not an AI diagnostic algorithm.

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

   • No, this is not an algorithm. The performance testing was for the monitor itself.

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

   • The "ground truth" for this device's performance is based on the specifications outlined in the AAPM Task Group 18 report ("Assessment of Display Performance for Medical Imaging Systems"). These are objective, measurable technical specifications (e.g., brightness, contrast, resolution, gray scale accuracy) rather than clinical diagnostic ground truth. The study states "The results showed that all the testing items met the criteria."

7. The sample size for the training set:

   • Not applicable. This is a hardware device (monitor), not an AI algorithm requiring a training set.

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

   • Not applicable. This is a hardware device (monitor).

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