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CX50N 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.

CX50N 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.

CX50N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.

The provided text is a 510(k) Summary for the WIDE Corporation CX50N LCD Monitor System. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain the detailed information needed to fill out all the specific sections of your request regarding acceptance criteria and the study proving the device meets them, particularly concerning AI or diagnostic performance studies.

The document focuses on the monitor's performance as a display device, not on an AI algorithm detecting medical conditions. The "acceptance criteria" discussed are related to display characteristics and compliance with electrical safety and electromagnetic compatibility standards, not diagnostic accuracy.

Here's a breakdown of what can and cannot be answered based on the provided text:

What can be extracted:

• 1. A table of acceptance criteria and the reported device performance: This is partially available for the monitor's display characteristics, but not for diagnostic performance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Based on the text, no such study was performed for an algorithm. The device is a monitor.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for a display device. The "ground truth" would relate to the display's ability to accurately represent images, not diagnose.
• 8. The sample size for the training set: Not applicable as there is no AI algorithm being trained.
• 9. How the ground truth for the training set was established: Not applicable.

What cannot be extracted from the provided text:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "bench tests" for the monitor's performance but doesn't detail sample sizes or data provenance in the way one would for a diagnostic AI study.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for a display device clearance.
• 4. Adjudication method (e.g. 2+1, 3+1, none) 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. This is a display monitor, not an AI-powered diagnostic tool.

Based on the provided document (K222719) for the CX50N LCD Monitor System:

The device under review is primarily an LCD Monitor System intended for displaying and viewing digital medical images, specifically for mammography and digital breast tomosynthesis applications. It is not an AI diagnostic algorithm. Therefore, many of the questions related to AI algorithm performance studies, expert ground truth establishment, and MRMC studies are not applicable to this device's clearance information.

The "acceptance criteria" and "study" described in the document relate to the physical and functional performance of the medical display monitor itself, ensuring it meets standards for image display quality and safety.

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

The document provides a comparison of technological characteristics between the subject device (CX50N) and its predicate device (K170783). While not explicitly labeled as "acceptance criteria," these are the performance metrics assessed. The "reported device performance" is essentially that the subject device's specifications are either the same or acceptable improvements/differences compared to the predicate.

Additional Bench Test Items (from Section 8):
The device was tested against instructions in 'Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017. Specific test items include:

• Pixel Defects
• Artifacts
• Luminance
• Reflection
• Luminance Uniformity
• Veiling Glare
• Color Uniformity
• Luminance Response
• Luminance at 30° and 45° in horizontal and vertical directions
• Temporal Performance Test
• Color Tracking
• Gray Tracking
• MTF (Modulation Transfer Function)

The document concludes that the "results of these tests demonstrate that CX50N meets the acceptance criteria and is adequate for this intended use."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "The bench tests below were performed on the CX50N". It does not specify a "sample size" in the context of cases/patients, as this is a hardware device test. It likely refers to testing a specific number of manufactured units or prototypes of the CX50N monitor. Data provenance (country, retrospective/prospective) is not applicable here as it is about hardware testing, not clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "ground truth" for a monitor is its specified technical performance characteristics and compliance with industry standards (e.g., DICOM Part 14 GSDF). These are measured instrumentally, not by human expert consensus on images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for establishing ground truth in diagnostic studies involving human interpretation, not for validating hardware performance.

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 device is a display monitor, not an AI diagnostic aid. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant for this clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in the sense that the monitor's performance was tested independently of human users' diagnostic abilities. However, this is not an "algorithm only" study as no diagnostic algorithm is part of this device cleared in this application. The standalone "performance" refers to the monitor's display characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance evaluation refers to established technical specifications and compliance with international and FDA-recognized consensus standards for medical displays (e.g., DICOM Part 14 GSDF, IEC 60601-1, IEC 60601-1-2) which are measured by instruments. It is not expert consensus, pathology, or outcomes data related to disease diagnosis.

8. The sample size for the training set
Not applicable. This device is a monitor and does not involve a training set for an AI algorithm.

9. How the ground truth for the training set was established
Not applicable. This device is a monitor and does not involve a training set for an AI algorithm.

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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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The CL24N LCD Monitor System is intended to be used in displaying digital medical images for review by trained medical practitioners. It does not support the display of mammography images for diagnosis.

CL24N is intended to display high resolution color and gravscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying and reviewing of medical images.

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

EzCal is packed with the display.

While using the CL24N product, use the EzCal S/W provided as a bundle to periodically check whether the product meets the intended use.

If the product does not meet the intended use, the product must be returned to the manufacturer or an authorized service center to be calibrated to a product that can be used normally.

The CL24N device is a 2.1MP Color LCD Monitor intended for displaying digital medical images for review by trained medical practitioners. It is not intended for displaying mammography images for diagnosis.

Here's a breakdown of the acceptance criteria and the study conducted to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the tests performed to demonstrate compliance with "Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017." The reported device performance is that it met these criteria.

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

The document does not specify a separate "test set" in the context of an AI/algorithm study. The tests mentioned were performed on the CL24N device itself, not on a dataset of medical images. Therefore, the "sample size" refers to the individual device undergoing testing.

• Sample Size for Test Set: Not applicable as it's a device performance test, not a data-driven algorithm test. The testing was conducted on the CL24N device.
• Data Provenance: Not applicable. The testing directly evaluated the monitor's physical and display characteristics.

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

Not applicable. The tests performed are objective, physics-based measurements of the monitor's display characteristics (e.g., luminance, uniformity, pixel defects). They do not require expert interpretation to establish ground truth in the way medical images would for diagnostic algorithms.

4. Adjudication Method for the Test Set

Not applicable. The tests are direct measurements against pre-defined technical specifications and industry standards. There is no need for expert adjudication.

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 comparative effectiveness study was done. This device is a medical monitor, an output display device, and does not incorporate AI for diagnostic assistance.

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

No standalone algorithm performance study was done. As stated, this is a display monitor, not a diagnostic algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by the specified technical parameters and compliance with recognized industry standards (e.g., IEC 60601-1, DICOM Part 14 GSDF, and the FDA's guidance document "Display Devices for Diagnostic Radiology"). The device's characteristics are measured and compared against these objective standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical monitor, not a machine learning model. There is no training set involved.

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

Not applicable. As there is no training set.

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CW60N LCD Monitor is intended to be used in displaying digital medical images for review by trained medical practitioners. It does not support the display of mammography images for diagnosis.

CW60N LCD Monitor is intended to display 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 and reviewing 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.

EzCal is packed with the display.

Here's an analysis of the provided text regarding the CW60N LCD Monitor, focusing on the acceptance criteria and the study proving compliance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal table of acceptance criteria with corresponding performance results directly tied to the "acceptance criteria" language. Instead, it lists a series of bench tests performed and then concludes that the device "meets the acceptance criteria." The performance evaluation is implied through the successful completion of these tests as per the FDA guidance document.

Below is an attempt to create a table based on the information provided, inferring acceptance criteria from the tests performed and the statement about meeting them.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "bench tests" performed on "the CW60N," implying that at least one physical unit of the device was tested. It does not provide the number of units or repeated measurements.
• Data Provenance: The tests were performed following the instructions in the FDA's "Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff" (October 2, 2017). This indicates the tests were conducted specifically for regulatory submission, likely prospective in nature, as they were performed on the CW60N device. There is no information regarding the country of origin of the data beyond the manufacturer being in the Republic of Korea.

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

• Number of Experts: Not applicable. The "ground truth" for the performance tests of a medical display monitor typically refers to established technical specifications and industry standards (like DICOM Part 14 GSDF or the FDA guidance document itself) rather than expert human interpretation of medical images. The tests evaluate the physical display characteristics.
• Qualifications of Experts: Not applicable. The tests are objective measurements against technical standards. While engineers or technicians with specific expertise in display calibration and testing would perform these, their qualifications in terms of medical image interpretation (e.g., radiologist experience) are not relevant here.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. As mentioned above, the tests are objective measurements against established technical specifications. There is no subjective human adjudication process described or required for these types of device performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs. without AI Assistance:

• No, an MRMC comparative effectiveness study was not done.
• This device is an LCD monitor for displaying medical images, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• No, a standalone (algorithm only) performance study was not done.
• This device is a hardware display monitor. Its performance is evaluated based on its physical characteristics and ability to accurately render images according to standards, not as a standalone algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for the device's performance is based on technical specifications, industry standards (e.g., DICOM Part 14 GSDF), and regulatory guidance documents (FDA's "Display Devices for Diagnostic Radiology"). These documents define the expected objective performance characteristics of a medical display monitor.

8. The Sample Size for the Training Set:

• Not applicable. This device is a hardware monitor, not an AI 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 a hardware display monitor.

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The CX30N(CX30PQX) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.

CX30N(CX30PQX) 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.

CX30N(CX30PQX) is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.

CX30N is basic model and CX30PQX is identical to CX30N, except model name.

The provided text is a 510(k) summary for the CX30N (CX30PQX) medical display device. It describes the device's technical specifications, intended use, and a comparison with a predicate device to establish substantial equivalence. The document describes bench tests for performance, but it does not describe a study involving human readers, AI assistance, or the establishment of ground truth for diagnostic accuracy.

Therefore, many of the requested items (2-9) in the prompt cannot be answered from the provided text, as they pertain to clinical or standalone performance studies, which were not conducted or reported for this device based on the provided summary. The device in question is a medical monitor (hardware), not an AI algorithm or a diagnostic software.

Here's what can be extracted from the provided text regarding acceptance criteria and performance, as well as the limitations:

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

The document lists various "Test Items" that were performed, implying these are the parameters for which acceptance criteria would have been defined. However, the specific numerical acceptance criteria and the reported numerical performance values are not explicitly stated in the provided 510(k) summary. It only indicates that "CX30N(CX30PQX) meets the acceptance criteria."

Note: The phrase "meets the acceptance criteria" is a general statement. For a detailed understanding, the actual criteria (e.g., maximum allowable pixel defects, specific luminance range, etc.) and the measured values would be needed, which are not in this summary. The tests were performed "following the instructions in 'Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017.'" This guidance would contain the specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the described tests are bench tests of a physical display device, not clinical or image-based studies with patient data.

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

This information is not applicable for the reasons stated above. Ground truth, in this context, would relate to image interpretation, not display performance.

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

This information is not applicable for the reasons stated above.

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

An MRMC study was not performed as this device is a medical monitor, not an AI-powered diagnostic tool. The document explicitly states "No clinical studies were considered necessary and performed."

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

A standalone performance study was not performed beyond the physical bench tests for the display's technical specifications. This device is not an algorithm.

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

This information is not applicable for the reasons stated above. For the bench tests, the "ground truth" would be the engineering specifications and calibrated measurement tools for display performance.

8. The sample size for the training set

This information is not applicable. This document describes a medical display monitor, not a machine learning model.

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

This information is not applicable. This document describes a medical display monitor, not a machine learning model.

In summary, the provided document focuses on the technical specifications and bench testing of a medical display monitor to prove its substantial equivalence to a predicate device. It explicitly states that "No clinical studies were considered necessary and performed," indicating that the device approval did not hinge on human reader studies or AI performance metrics.

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CW120N LCD Monitor System is intended to be used in displaying digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.

CW120N 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.

CW120N 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 system (CW120N). This document describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-based diagnostic device.

The "acceptance criteria" discussed in the document are limited to the performance of the display hardware itself, such as luminance, resolution, and color uniformity, and compliance with general medical electrical equipment standards (IEC 60601-1 and IEC 60601-1-2).

Therefore, based on the provided text, I cannot complete the requested table and sections regarding an AI/algorithm study. The document explicitly states: "No clinical studies were considered necessary and performed." This indicates that there was no study involving human readers, ground truth establishment, or sample sizes for diagnostic efficacy of an AI component.

Here's an explanation based on the available information:

Description of the Device and its Purpose:
The CW120N LCD Monitor System is a display device intended for viewing digital medical images, specifically for digital mammography and digital breast tomosynthesis applications. It is a hardware product, not an AI or algorithm-based diagnostic tool that interprets images. Its functionality is to accurately display images.

Acceptance Criteria for CW120N (as a display device):
The acceptance criteria are derived from bench tests to ensure the monitor's display quality and compliance with relevant standards for medical displays. These are physical and performance characteristics of the monitor, not diagnostic accuracy criteria for an AI.

Based on the provided text, the device is a medical display monitor, not an AI/algorithm-based diagnostic device. Therefore, information regarding acceptance criteria and studies for AI performance (such as sensitivity, specificity, MRMC studies, ground truth, and training sets for an algorithm) is not present in the document.

If the request implied a different type of device or study not contained within the provided text, I would not be able to generate that information.

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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 CX50N(CX50YQS) 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.

CX50N(CX50YQS) 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 color image display. The WIDE controller board is installed into the PACS workstation computer system to display PACS medical images.

The provided text describes the WIDE Corporation CX50N(CX50YQS) LCD Monitor System, which displays medical images for review and analysis, specifically for digital mammography and digital breast tomosynthesis. The document is a 510(k) summary indicating substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a "test set" in the context of medical images or patient data. The testing described focuses on the monitor's technical specifications and compliance with international standards for electrical safety and electromagnetic compatibility. Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective) related to imaging data. The device itself (the monitor) underwent non-clinical testing.

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

Since this is a medical display device, not an AI-powered diagnostic tool, the concept of "ground truth" derived from expert interpretation of medical images does not apply in the context of the described testing. The 'ground truth' for the acceptance criteria would be the established technical standards and performance specifications for medical displays.

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

Not applicable, as there was no test set involving human interpretation of medical 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:

Not applicable. This device is a medical monitor, not an AI-assisted diagnostic tool. No MRMC comparative effectiveness study was reported.

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

Not applicable. This device is an LCD monitor; it does not perform algorithmic analysis or have a standalone diagnostic function. Its performance is evaluated based on its ability to accurately display images.

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

For the safety and effectiveness testing of the monitor, the "ground truth" was established by international and FDA-recognized consensus standards (IEC 60601-1, IEC 60601-1-2) which define the technical performance requirements for medical electrical equipment and displays. The tests for resolution, luminance, contrast, and noise are objective measurements against these predefined technical specifications.

8. The sample size for the training set:

Not applicable. This device is a hardware monitor, not a machine learning algorithm that requires a training set.

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

Not applicable, as there was no training set.

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The MX50TQS) 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 breast tomosynthesis applications.

MX50T(MX50TQS) 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 the WIDE Corporation's MX50T(MX50TQS) LCD monitor system, which is intended for displaying and viewing digital medical images for review and analysis by trained medical practitioners, specifically for digital mammography and breast tomosynthesis applications.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that the MX50T(MX50TQS) has "similar performance" for Brightness and Contrast Ratio compared to the predicate device, although the numerical values are slightly different. The acceptance criteria for these would likely be defined by a range that encompasses these values and demonstrates sufficient image quality for the intended use. The other listed parameters are either identical or the subject device offers an additional compatible input signal (DisplayPort), which expands functionality without compromising the predicate's capabilities.

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

• Sample Size: Not explicitly stated. The document mentions "tests conducted for resolution, luminance, contrast and noise" without specifying the number of units or images tested.
• Data Provenance: Not explicitly stated. The non-clinical tests were conducted to comply with international and FDA-recognized consensus standards (IEC 60601-1 and IEC 60601-1-2). Given the manufacturer's location (Republic of Korea), it's likely the testing was performed there or by a recognized testing facility. The data provenance is non-clinical, related to electrical safety and performance characteristics of the monitor itself, not patient data.

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

• Not applicable as no clinical studies were performed. The "ground truth" for this device relates to its technical specifications and adherence to safety and performance standards for a medical display.

4. Adjudication method for the test set:

• Not applicable as no clinical studies were performed requiring expert adjudication of patient data. The "adjudication" for this type of device would involve verifying that the physical measurements and tests meet the specified technical criteria in the standards.

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 or comparative effectiveness study involving human readers or AI was performed. The device is a medical display, not an AI-powered diagnostic tool.

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

• Not applicable. The device is a medical monitor, not an algorithm. Its performance is evaluated based on its physical characteristics and adherence to technical standards for displaying medical images.

7. The type of ground truth used:

• The "ground truth" for the non-clinical tests consisted of the established requirements and specifications outlined in the international and FDA-recognized consensus standards (IEC 60601-1, IEC 60601-1-2, and likely other display performance standards implicitly referenced by the tests for resolution, luminance, contrast, and noise). This is a technical, rather than a clinical, ground truth.

8. The sample size for the training set:

• Not applicable. This device is an LCD monitor, not an AI/machine learning algorithm requiring a training set.

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

• Not applicable. As noted above, this device does not utilize a training set.

Summary of the Study Proving Acceptance Criteria are Met:

The study proving the device meets its acceptance criteria is a non-clinical performance and safety testing study.

• Study Design: The manufacturer conducted tests to evaluate the device's technical specifications and adherence to relevant safety and performance standards.
• Tests Performed:
  • Safety Tests: Compliance with IEC 60601-1 (General Requirements For Basic Safety And Essential Performance) and IEC 60601-1-2 (Electromagnetic Compatibility).
  • Performance Tests: Evaluation of resolution, luminance, contrast, and noise.
• Results and Conclusion: "The tests conducted for resolution, luminance, contrast and noise all met the acceptance criteria specified in the standards." and "Additionally, the safety of the subject device was validated through tests including IEC60601-1 and IEC 60601-1-2. The effectiveness of the device was validated through tests for resolution, luminance, contrast and noise." The overall conclusion is that the MX50T(MX50TQS) "meets the acceptance criteria and is adequate for this intended use."

In essence, the "study" for this medical display is a series of engineering and electrical tests demonstrating that the monitor physically performs as expected according to its technical specifications and meets the regulatory safety and electromagnetic compatibility requirements for medical electrical equipment. No clinical data or human-in-the-loop studies were deemed necessary due to the nature of the device (a display monitor).

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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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