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5 MP Medical Monochrome Reference Display, MDM2010-5NC is intended to be used in various kinds of medical images applications including digital mammography system.

Medical Display, MDM2010-5NC is a 20.1" monochrome LCD monitor that displays image for medical use. It provides 5 mega pixel (2560*2048) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, PACS and digital mammography system.

The provided document describes a 510(k) premarket notification for a medical display device, the Medical Display, MDM2010-5NC. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a full clinical study with specific acceptance criteria in the way a novel AI algorithm would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable to this type of device and submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical display, the "acceptance criteria" revolve around its technical specifications being comparable to or meeting the standards for general medical image display and specifically digital mammography. The "reported device performance" is essentially its listed technical capabilities that demonstrate it meets these general requirements and is equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable. This is a hardware device (a monitor), not an AI algorithm evaluated on a test dataset of medical images. The evaluation is primarily based on technical specifications and comparison to a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. See point 2.

4. Adjudication Method for the Test Set

• Not Applicable. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improve with AI vs. Without AI Assistance

• Not Applicable. This is a medical display, not an AI-powered diagnostic algorithm. There is no AI component or human reader performance study mentioned.

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

• Not Applicable. This is a hardware monitor. There is no algorithm to evaluate in standalone mode.

7. The Type of Ground Truth Used

• Not Applicable. For this device, the "ground truth" is its technical specifications and compliance with industry standards for medical displays. There isn't a diagnostic "ground truth" in the sense of a disease state.

8. The Sample Size for the Training Set

• Not Applicable. No training set is used for a medical display device.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. No training set is used for a medical display device.

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is the Substantial Equivalence (SE) determination made by the FDA based on the 510(k) submission.

The core of the study is a comparison to a predicate device:

• Predicate Device: RadiForce G51 21.3" 5MP Monochrome LCD Monitor by EIZO NANAO CORPORATION. (K042755).
• Methodology: The manufacturer (CHILIN TECHNOLOGY CO., LTD.) submitted technical specifications and a justification that their device (MDM2010-5NC) has the "same intended use as the predicate device" and that they "both share similar characteristics except some minor differences which do not raise new questions of safety and effectiveness."
• Conclusion: The FDA reviewed these claims and, finding the device substantially equivalent to the legally marketed predicate, allowed it to proceed to market. This means the FDA agreed that the MDM2010-5NC's technical performance and intended use are sufficiently similar to the predicate that it meets the necessary safety and effectiveness standards without requiring a new, extensive clinical trial.

In essence, for this type of device, the "acceptance criteria" are implicitly met by demonstrating that the device is technically comparable to a device already deemed safe and effective for its stated indications for use.

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