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The MX50N(MX50YQS) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.

MX50N(MX50YQS) is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system to display PACS medical images.

The document provided is a 510(k) premarket notification for a medical LCD monitor system (MX50N(MX50YQS)). This type of submission is focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, the information typically found in studies proving a device meets acceptance criteria for an AI/algorithm-based diagnostic device will not be present.

Based on the provided document, here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. This submission is for a medical monitor, not an AI/algorithm-based diagnostic device that processes image data for diagnosis directly. The "tests" mentioned are technical performance verifications of the display hardware (resolution, luminance, contrast, noise) against engineering specifications and international standards, not a diagnostic accuracy study on a dataset of patient cases.
• Data Provenance: Not applicable. The tests are technical assessments of the device itself.

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

• Not applicable. Ground truth in the context of diagnostic interpretation by experts is not relevant for technical performance testing of a monitor. The "ground truth" here is the specified technical performance metrics and compliance with industry standards.

4. Adjudication Method for the Test Set

• Not applicable. There is no diagnostic interpretation or consensus needed for the technical performance tests of a monitor.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The device (a medical monitor) is not an AI algorithm that improves human reader performance. It is a display device for medical images. The submission focuses on its technical specifications and compliance with safety standards.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. The MX50N(MX50YQS) is a display device, not an algorithm. Its "standalone performance" refers to its technical specifications (brightness, resolution, contrast, etc.) and compliance with electrical and safety standards.

7. Type of Ground Truth Used

• For the technical performance tests (resolution, luminance, contrast, noise), the "ground truth" or reference is established by specified acceptance criteria in international and consensus standards (e.g., IEC 60601-1, IEC 60601-1-2 and likely other display performance standards such as DICOM Part 14, though not explicitly listed as a test item in the summary).

8. Sample Size for the Training Set

• Not applicable. The MX50N(MX50YQS) is a hardware device (LCD monitor system) and not an AI or machine learning algorithm that requires a training set.

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

• Not applicable, as there is no training set for this device.

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The MW100 (Mammography) LCD Monitor System™ 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 MW100 (Mammography) LCD Monitor System™ is a flat panel hi-resolution LCD monitor system for displaying medical images. The system consists of a state-of-the-art LCD monitor that connects to a hi-resolution graphic control board (not supplied by WIDE Corporation), that is installed into a PACS workstation. The MW100 (Mammography) LCD Monitor System consists LCD monitor. The computer, computer hardware, any workstation PACS software, monitor image calibration software (e.g. Lumical Software and graphic interface is supplied by the user and should be based upon WIDE Corporation recommendations as described in the MW-100 User Manual.

The provided text describes a medical device, the MW100 (Mammography) LCD Monitor System, and its acceptance for market. However, it does not contain the detailed information requested regarding specific acceptance criteria metrics, a study proving device performance against those criteria, sample sizes, expert qualifications, or ground truth methodologies.

The document is a 510(k) summary for a medical device submitted to the FDA, focusing on establishing substantial equivalence to a predicate device. This type of submission typically highlights that the new device is as safe and effective as a device already on the market, rather than presenting a performance study with detailed acceptance criteria and results.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states: "The Validation Test Plan was designed to evaluate all input functions, output functions, and that as required by the risk analysis, designated individuals performed all verification and validation activities on the WIDE MW-100 device. The results demonstrated that the predetermined acceptance criteria were met." However, it does not specify what those "predetermined acceptance criteria" were or report the explicit device performance against them in a table format with specific metrics (e.g., resolution, luminance uniformity, contrast ratio, etc.). It only vaguely mentions that "the requirements for monitors as outlined in AMLCD AAPM TG 18 & Specifications are provided in the 510(k)".

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

Not available in the provided text. The document mentions "nonclinical testing" but does not describe a test set in the context of image data or patient studies. It refers to internal testing of the monitor system itself, not its performance in interpreting medical images.

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

Not applicable. The device is a monitor, not an AI or diagnostic tool that requires ground truth established by experts for its performance evaluation in this context. The document explicitly states: "Diagnosis is not performed by the monitor but by Radiologists, Clinicians and referring Physicians." and "Note: The subject device does not include any automated or semi-automated process for the detection of nodules or other shapes."

4. Adjudication Method for the Test Set

Not applicable. As above, this monitor does not perform diagnostic tasks that would require a test set with adjudicated ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. No MRMC study is mentioned. This device is a display monitor, not an AI-assisted diagnostic tool for which an MRMC study would typically be conducted.

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

No. The device is a monitor. Its primary function is to display images for human interpretation, not to perform standalone algorithmic diagnostic tasks.

7. The Type of Ground Truth Used

Not applicable. For this device (a monitor), "ground truth" in the context of diagnostic accuracy for medical images is not relevant to its regulatory approval described here. The "ground truth" for the monitor itself would be its compliance with technical specifications (like those in AAPM TG 18), but these specific details are not provided in the summary.

8. The Sample Size for the Training Set

Not applicable. This device is a display monitor and does not involve AI or machine learning algorithms that would require a training set.

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

Not applicable. As above, no training set is involved.

In summary, the provided 510(k) summary focuses on demonstrating the substantial equivalence of an LCD monitor system to a predicate device based on its technical characteristics and intended use, rather than presenting a performance study with detailed clinical acceptance criteria and results. The document explicitly states that the monitor itself does not perform diagnosis or automated detection.

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