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MX50N LCD Monitor System is intended to be used in displaying digital medical images for review and analysis by trained medical practitioners. It is specifical mammography applications and digital breast tomosynthesis applications.

MX50N LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.

EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.

MX50N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.

The provided text is related to a 510(k) premarket notification for a medical monitor (MX50N), not an AI/ML medical device. Therefore, much of the requested information (such as AI model performance, training/test sets, expert adjudication, MRMC studies, etc.) is not applicable or available in this document.

The document discusses the technical specifications, intended use, and non-clinical testing of the MX50N monitor, comparing it to a predicate device. The "acceptance criteria" here refer to the device meeting specific technical standards and performance metrics for medical display devices, rather than an AI model's diagnostic accuracy.

Given this limitation, I will extract and present the relevant information, while noting when the requested details are not applicable to this type of device and application.

Description of Acceptance Criteria and Study Proving Device Meets Criteria for the MX50N Medical Monitor

The MX50N is a medical display monitor intended for displaying digital medical images, specifically for mammography and digital breast tomosynthesis applications. The acceptance criteria for this device are based on its technical performance and compliance with relevant medical device standards, ensuring it can accurately display medical images for review and analysis by trained practitioners.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a medical monitor like the MX50N are based on established performance characteristics for display devices in diagnostic radiology. The reported device performance is demonstrated through bench testing against these characteristics.

The key improvements in the subject device (MX50N) over the predicate are in Maximum Luminance and Contrast Ratio, both of which are critical performance aspects for medical displays, especially for mammography.

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

This is not applicable as the device is a medical monitor, not an AI/ML algorithm that processes patient data. The "test set" here refers to the physical monitor itself undergoing bench testing, not a dataset of medical images.

• Sample Size for Test Set: Not applicable in the context of data. The "sample" is the physical device unit(s) subjected to testing.
• Data Provenance: Not applicable. The testing verifies the physical and electrical performance of the monitor.

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

Not applicable. The "ground truth" for a medical display monitor is its adherence to technical specifications and industry standards for image display. This is verified by objective bench tests and compliance with recognized consensus standards (e.g., DICOM Part 14 GSDF, IEC 60601 series). No human experts are used to establish "ground truth" in this context.

4. Adjudication Method for the Test Set

Not applicable. This is a technical performance verification, not a clinical study involving interpretation or adjudication of diagnostic findings.

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

No, an MRMC comparative effectiveness study was not done. These studies are typically performed for CAD or AI-assisted diagnostic devices to evaluate their impact on human reader performance. For a medical monitor, the effectiveness is demonstrated by its ability to accurately and consistently display images according to established standards.

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

No, this is not applicable. The device is a display monitor, not an algorithm. Its performance is inherently linked to human interaction (a medical practitioner viewing images on it).

7. The Type of Ground Truth Used

The "ground truth" for this device is compliance with:

• Technical Specifications: The monitor's ability to meet its stated performance characteristics (e.g., resolution, luminance, contrast, response time).
• Industry Standards: Adherence to recognized consensus standards like DICOM Part 14 GSDF for grayscale display function, and IEC 60601 series for medical electrical equipment safety and essential performance.
• Predicate Device Equivalence: Demonstrating that its performance is substantially equivalent to, or improved upon, that of a legally marketed predicate device.

This "ground truth" is established through engineering verification and validation (bench testing) against these objective standards.

8. The Sample Size for the Training Set

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

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

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

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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 and digital breast tomosynthesis 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 provided text describes a 510(k) premarket notification for the MX50N(MX50YQS) LCD Monitor System, which is intended for displaying and viewing digital medical images, specifically for digital mammography and digital breast tomosynthesis applications. The submission aims to demonstrate substantial equivalence to a predicate device (K160326).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the compliance with international standards. The performance metrics are a direct comparison between the subject device and the predicate device.

Note regarding "Acceptance Criteria": For the parameters where the subject device’s performance is directly aligned with the predicate (e.g., Response Time, LCD Panel Size), the predicate's performance acts as the de facto acceptance criterion for demonstrating substantial equivalence. For parameters with slight differences (like Contrast Ratio), the acceptance is based on the argument that the difference is not critical.

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

The document does not describe a test set in the traditional sense of a dataset for evaluating an AI algorithm. This device is a display monitor, not an AI diagnostic tool that processes clinical data.

Therefore, this information is Not Applicable in the context of this device and submission. There is no mention of clinical data or patient samples being used for testing. The testing performed is non-clinical, related to the display's technical specifications and safety.

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

As there is no "test set" of clinical data to establish ground truth for this display monitor, this information is Not Applicable.

4. Adjudication Method for the Test Set

As there is no "test set" of clinical data, this information is 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

No MRMC study was conducted. This device is a display monitor, not an AI algorithm intended to assist human readers directly or to be evaluated for its impact on reader performance.

Therefore, this information is Not Applicable.

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

This device is not an algorithm, but a hardware display monitor. Thus, a standalone algorithm performance study is Not Applicable.

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

Ground truth in the clinical sense (expert consensus, pathology) is Not Applicable, as this is a display monitor and not an AI diagnostic algorithm. The "ground truth" for the device's technical performance is established by the specifications and measurements according to recognized engineering and medical device standards.

8. The Sample Size for the Training Set

No training set is mentioned or applicable. This device is a display monitor, not a machine learning model.

Therefore, this information is Not Applicable.

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

As no training set is applicable, this information is Not Applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a non-clinical performance evaluation and compliance testing against recognized international standards and a comparison to a legally marketed predicate device.

• Type of Study: Non-clinical (bench testing, technical specification validation, standard compliance). No clinical studies were considered necessary or performed.
• Methodology:
  • Substantial Equivalence Comparison: The MX50N(MX50YQS) was directly compared, parameter by parameter, with the predicate device (5MP Monochrome LCD Monitor MS55i2, K160326). This comparison covered intended use, technological characteristics, and various technical specifications (response time, LCD panel size, resolution, pixel pitch, brightness, contrast ratio, input signal, power supply, color/monochrome). The conclusion was that the devices were substantially equivalent, with any differences (e.g., contrast ratio) not adversely affecting the device's use.
  • Compliance with Consensus Standards: The device underwent testing to comply with the following international and FDA-recognized consensus standards:
    • IEC 60601-1: Medical Electrical Equipment -- Part 1: General Requirements For Basic Safety And Essential Performance.
    • IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
• Performance Metrics Evaluated: Tests were conducted for resolution, luminance, contrast, and noise.
• Conclusion: The results of these tests demonstrated that the MX50N(MX50YQS) met the acceptance criteria specified in the standards and was adequate for its intended use. The device was found to be as safe and effective as the predicate device.

In essence, the "study" is a comprehensive engineering and electrical safety validation against established industry benchmarks and a direct side-by-side technical comparison with a cleared device.

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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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