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The Medical LCD Monitor is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.

The Medical LCD Monitor (Model: KT-D213V5E) is designed for the purpose of medical applications such as X-ray, radiology, MRI, endoscopy or mammography imaging display. The high-resolution LCD panel with a resolution of 2560 x 2048, combined with a high performance image processing controller, provides the users high-definition and high-quality medical image displays. The medical monitor complies with international EMC/ safety standards.

The provided document is a 510(k) premarket notification for a Medical LCD Monitor (Model: KT-D213V5E) and primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about an AI/ML-driven medical device, nor does it detail a study that proves the device meets specific acceptance criteria in the context of an AI/ML model's performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device based on this document. The document describes a medical display monitor and its technical specifications, along with standard performance tests to ensure basic functionality and safety/effectiveness consistent with its predicate.

The "Performance Data" section lists several tests performed on the subject device and states that "passed the pre-set criteria," but it does not specify what those criteria are or provide any detailed results.

Here's a summary of what is available in the document, which might be similar to how a non-AI medical device would list performance:

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

The document lists performance tests that were conducted and states they "passed the pre-set criteria," but it does not provide the specific acceptance criteria or detailed reported performance data for these tests.

Since the device described is a Medical LCD Monitor and not an AI/ML algorithm, the following points are not applicable and cannot be answered based on the provided text:

• 2. Sample size used for the test set and the data provenance (Not applicable for a display monitor's technical performance tests)
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not applicable, as "ground truth" in the context of expert diagnosis from images is not relevant for a display monitor's technical performance)
• 4. Adjudication method 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, as this is not an AI device)
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable, as this is not an AI algorithm)
• 7. The type of ground truth used (Not applicable)
• 8. The sample size for the training set (Not applicable, as there is no training set for a display monitor)
• 9. How the ground truth for the training set was established (Not applicable)

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The Medical LCD Monitors are intended to be used in various kinds of medical image applications (excluding digital mammography) for which the device complies with the performance specifications of the system.

The Medical LCD Monitors are designed for the purpose of medical applications such as X-ray, radiology, MRI or endoscopy imaging display. The high-resolution LCD panels with a resolution of 1280x1024, 1600x1200, 2048x1536 or 2560x2048, combined with a high-performance image processing controller, provides the users extremely high-definition and high-quality medical image displays. These medical monitors comply with international EMC/ safety standards.

The provided text is a 510(k) summary for a Medical LCD Monitor (Kostec Co., Ltd., K123944). This type of document is for demonstrating substantial equivalence to a predicate device and does not typically contain detailed information about specific clinical studies or performance against acceptance criteria in the way that would be found for an AI/ML medical device submission.

Medical LCD Monitors are display devices, not diagnostic algorithms. Their performance is generally assessed against technical and international standards for image display quality, electrical safety, and electromagnetic compatibility. The "acceptance criteria" for such a device are these compliance standards and the ability to display medical images accurately.

Therefore, many of the questions asked, particularly those related to sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and ground truth establishment for training data, are not applicable to this type of device and submission.

Here's a breakdown of the available information based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are compliance with various international standards. The document states that the device has been tested against and passed these standards.

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

• Sample size: Not applicable/Not specified in the document. Performance is based on technical testing of the monitor units, not analysis of medical image datasets.
• Data provenance: Not applicable. The "data" here refers to the performance characteristics of the monitor itself, not clinical data.

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 diagnostic accuracy, is not relevant for a medical display monitor. The "ground truth" for display performance is established by technical specifications and standards.

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

• Not applicable. This is not a study involving human interpretation of images.

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

• No. This is a medical monitor, not an AI diagnostic algorithm. MRMC studies are not relevant.

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

• Not applicable. This is hardware (monitor), not a software algorithm.

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

• Not applicable in the typical sense. The "ground truth" for a medical monitor's performance is adherence to established technical specifications and international standards for image display, electrical safety, and electromagnetic compatibility.

8. The sample size for the training set

• Not applicable. There is no "training set" for a medical LCD monitor in the context of an AI/ML device.

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

• Not applicable.

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