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The MD302C4 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.

To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display controllers.

MD302C4 cannot be used for a life-support system.

This device must not be used in digital mammography.

This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.

Medical Display, MD302C4 is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

This document describes a 510(k) premarket notification for a diagnostic imaging LCD monitor (MD302C4). The submission aims to demonstrate substantial equivalence to a predicate device (MD242C2) rather than proving the device meets specific acceptance criteria through a clinical study. As such, most of the requested information (sample size, data provenance, expert qualification, adjudication method, MRMC study, standalone performance, training set details) is not applicable to this type of submission.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in the typical sense of a clinical study with performance metrics. Instead, it compares the technical specifications and intended use of the new device (MD302C4) to a predicate device (MD242C2) to establish substantial equivalence. The "acceptance criteria" here are implicitly that the new device's performance characteristics are comparable or superior to the predicate device, or fall within acceptable ranges for diagnostic display devices.

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The MD211C3 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used in conjunction with NEC approved display controllers. MD211C3 cannot be used for a life-support system. This device must not be used in digital mammography. This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.

Medical Display, MD211C3 is a 21.3" Color LCD monitor that displays image for medical use, It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MD211C3 display, structured as requested.

Important Note: The provided document is a 510(k) summary for a medical display monitor. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a full efficacy study of a new medical algorithm or diagnostic tool. Therefore, many of the requested categories related to algorithm performance, ground truth, and human reader studies are not applicable or will have "N/A" (Not Applicable) as the MD211C3 is a display device, not an AI-powered diagnostic tool.

Acceptance Criteria and Study for MD211C3 Diagnostic Imaging LCD Monitor

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MD211C3 are primarily based on demonstrating substantial equivalence to its predicate device, the L218TL 3MP Monochrome LCD Monitor (K090215), as well as adherence to relevant medical and safety standards. The document outlines a comparison of technical specifications between the two devices.

2. Sample Size for Test Set and Data Provenance

This is an approval for a display monitor, not an AI algorithm or a diagnostic device that analyzes data. Therefore, the concept of a "test set" comprised of medical images or patient data, and its provenance, is not applicable. The testing would have involved engineering and performance verification tests of the monitor itself (e.g., luminance, chromaticity, resolution, stability, adherence to DICOM Part 14 grayscale standard display function, and safety standards like IEC 60601-1 and EN60601-1-2).

• Sample Size for Test Set: N/A (Not applicable for a display monitor).
• Data Provenance: N/A (No patient or image data set used in the sense of an algorithm study). Testing would typically occur in laboratory settings by engineers.

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

• Number of Experts: N/A
• Qualifications of Experts: N/A

As this is a display monitor, the "ground truth" relates to its physical performance characteristics (e.g., precise measurements of brightness, contrast, color accuracy, resolution, stability, and adherence to DICOM calibration) as measured by calibrated instruments and verified against engineering specifications and industry standards. This isn't a diagnostic ground truth established by medical experts.

4. Adjudication Method for the Test Set

• Adjudication Method: N/A

There is no "adjudication" in the context of an algorithm's output for a display monitor. Performance is measured against objective technical standards.

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

• Was an MRMC study done? No.
• Effect size of human readers improving with AI vs without AI assistance: N/A.

This device is a display monitor, not an AI-enabled diagnostic tool; therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? No.

This device is a display monitor. It does not contain an algorithm that performs diagnostic analysis in a "standalone" fashion. Its function is to display images accurately for human interpretation.

7. Type of Ground Truth Used

The "ground truth" for a medical display monitor is defined by:

• Objective Technical Specifications: Measurements of luminance, chromaticity, resolution, uniformity, stability, and viewing angle characteristics.
• Adherence to Industry Standards: Conformance to DICOM Part 14 Grayscale Standard Display Function (GSDF) for accurate grayscale reproduction.
• Safety and EMC Standards: Compliance with standards like IEC 60601-1 (medical electrical equipment safety), EN60601-1-2 (electromagnetic compatibility), and DIN V 6868-57 (quality assurance for image display systems).

8. Sample Size for the Training Set

• Sample Size for Training Set: N/A

As a display monitor, there is no "training set" in the context of machine learning. The device is manufactured and calibrated according to established engineering principles and production controls.

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

• How Ground Truth for Training Set Was Established: N/A

Since there is no training set for a machine learning algorithm, this question is not applicable. The display's performance characteristics (its "ground truth") are established through design specifications, calibration procedures, and adherence to international standards for medical displays.

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The MD211C2 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.

To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display controllers.

MD211C2 cannot be used for a life-support system.

This device must not be used in digital mammography.

This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.

Medical Display, MD211C2 is a 21.3" Color LCD monitor that displays image for medical use. It provides 1.9 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

This document describes a medical device called the MD211C2, a 21.3" Color LCD monitor intended for displaying and viewing digital images for diagnosis by trained physicians. The submission (K130772) from NEC Display Solutions Ltd. seeks to establish substantial equivalence to a predicate device, the L217TG. The study provided focuses on demonstrating equivalence through a comparison of technical specifications, rather than a clinical performance study with acceptance criteria in the typical sense for an AI/CADe device.

Here's an analysis based on the provided text, outlining what's available and what's not given the nature of the device (a display monitor):

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present specific acceptance criteria in the form of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because it's a display monitor, not a diagnostic algorithm. Instead, it relies on demonstrating that the new device's technical specifications are comparable to or improved over a legally marketed predicate device. The "acceptance criteria" can be inferred as matching or exceeding the performance characteristics of the predicate device (L217TG).

The study essentially is the comparison table provided, demonstrating that the MD211C2 is technically equivalent or superior to the L217TG across critical display specifications and meets relevant safety and performance standards.

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

• Sample Size: Not applicable. This is not a study assessing diagnostic performance on a dataset of patient images. It's a technical comparison of a hardware device.
• Data Provenance: Not applicable. The "data" here refers to the specifications and performance measurements of the display monitors themselves, 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. Ground truth, in the context of diagnostic interpretation, is not relevant for evaluating a display monitor's technical specifications.

4. Adjudication method for the test set:

• Not applicable. There is no diagnostic test set requiring 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, a MRMC study was not done. This device is a display monitor, not an AI or CADe system. There is no AI component involved, so no improvement statistics for human readers are relevant.

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

• No, a standalone algorithm performance study was not done. This is a display monitor, not an algorithm.

7. The type of ground truth used:

• Not applicable. Ground truth for diagnostic interpretations is not relevant. The "ground truth" for this device's performance relies on engineering specifications, measurements, and adherence to established standards (e.g., DICOM, IEC).

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning algorithms requiring a training set.

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

• Not applicable. As there is no training set, there is no ground truth for it to be established.

Summary of the Study:

The study presented is a technical comparison between the proposed device (MD211C2) and a legally marketed predicate device (L217TG). It primarily relies on a comparative table of specifications and certifications to demonstrate substantial equivalence. The conclusion drawn is that both devices share the same intended use, design, performance, and safety characteristics (radiation, mechanical, electrical, human factors, DICOM conformance), and utilize similar materials and environmental compatibility. This comparison allows the manufacturer to assert that the MD211C2 is substantially equivalent to the predicate device, enabling its market clearance under 510(k).

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MD301C4 is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. Caution: MD301C4 cannot be used for a life-support system. This unit is designed as component of a final system which is compliance to IEC60601-1-1 requirements. MD301C4 must not be used in digital mammography.

Medical Display, MD301C4 is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS. MD301C4 conforms with DICOM.

The provided text is a 510(k) summary for a medical display (MD301C4). It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI algorithm.

This document describes a medical display device and demonstrates its substantial equivalence to a predicate display device. It focuses on physical and technical specifications of the monitor itself, rather than the performance of an AI algorithm or software. Therefore, most of the requested information cannot be extracted from the provided text.

Here is an explanation of why the requested information is not available:

• This is a 510(k) for a display monitor, not an AI diagnostic device. The device (MD301C4) is a "Color LCD Monitor, Color Diagnostic Display," intended for "displaying and viewing of digital images for diagnosis." It does not contain or utilize an AI algorithm for diagnostic purposes.
• The "study" mentioned is a comparison of the new monitor to a predicate monitor to establish substantial equivalence. It's not a clinical performance study involving AI and human readers. The conclusion states: "Device with trade name MD301C4 (model name is L309TY) and predicate device with trade name MD304MC (model name is L307TD) have the same target population... it shares the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (UL60601-1) and human factors." This is the "study" proving it meets acceptance criteria, which is essentially demonstrating equivalence to an already approved device.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be inferred or stated as "not applicable" based on the document:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: The primary acceptance criterion for this 510(k) is "substantial equivalence" to the predicate device (MD304MC, K083916) in terms of design, performance (implied regulatory compliance like DICOM conformance), safety (radiation, mechanical, electrical), human factors, and intended use. Specific quantitative performance metrics for diagnostic accuracy of an AI are not applicable.
   • Reported Device Performance: The document states the device "conforms with DICOM" and has "4 mega pixel (2560*1600) resolution with adjustable gamma gray scale." The "performance" in the context of this device refers to its display capabilities and regulatory compliance, not diagnostic accuracy.

2. Sample size used for the test set and the data provenance: Not applicable. There is no diagnostic AI test set. This is a display device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no AI test set requiring expert ground truth.

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: No, an MRMC study was not done for AI performance. The equivalence study compares properties of the display monitors themselves.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. 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. This is not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

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The L218TJ Color display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards. The L218TJ cannot be used for a life-support system. This device must not be used in digital mammography. This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.

Medical Display, L218TJ is a 21.3" Color LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*156) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

The provided document is a 510(k) summary for a medical display (LCD monitor), not an AI/ML device. Therefore, it does not contain information on acceptance criteria for an AI algorithm's performance, nor does it describe a study to prove such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device based on design, performance, safety, and intended use for the LCD monitor itself, not for an AI component.

Here's an breakdown of the information that can be extracted, and where the requested AI/ML specific information is not present:

Missing Information (as this is not an AI/ML device submission):

• A table of acceptance criteria and the reported device performance: This document specifies performance characteristics for an LCD monitor (e.g., resolution, grayscale), but not for an AI algorithm's diagnostic performance (e.g., sensitivity, specificity, AUC).
• Sample size used for the test set and the data provenance: Not applicable to an LCD monitor's performance evaluation in this context.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Information that can be extracted from the provided text, re-contextualized for a medical display:

1. Acceptance Criteria and Reported Device Performance (Table – Conceptual, based on device specifications):

   Acceptance Criteria (Predicate Device K063579) (Inferred)	Reported Device Performance (L218TJ)
   21.3" Color LCD Monitor	21.3" Color LCD Monitor
   2 Mega Pixel Resolution (2048x1536 is 3MP, but predicate is 2MP)	3 Mega Pixel (2048*1536) Resolution
   Adjustable Gamma Grayscale (Inferred)	Adjustable Gamma Grayscale
   Target Population: Trained practitioners in hospital	Target Population: Trained physicians
   Intended Use: Displaying digital image diagnosis	Intended Use: Displaying digital image diagnosis
   Design: Same (Claimed)	Design: Same (Claimed)
   Performance: Same (Claimed)	Performance: Same (Claimed)
   Radiation Safety (EN60601-1-2) Compliant	Radiation Safety (EN60601-1-2) Compliant
   Mechanical Safety Compliant	Mechanical Safety Compliant
   Electrical Safety (UL60601-1) Compliant	Electrical Safety (UL60601-1) Compliant
   Human Factors Compliant	Human Factors Compliant
   Compatibility with environment/other devices	Compatibility with environment/other devices
   Exclusions: Not for life-support, not for digital mammography	Exclusions: Not for life-support, not for digital mammography
   Note: The resolution of the predicate device is not explicitly stated in the provided text beyond "2MP". The subject device has 3MP. The claim of "same performance" could be interpreted as meeting functional display requirements rather than strict pixel count identity.

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

   • Not applicable. This is a 510(k) for an LCD monitor asserting substantial equivalence based on technical specifications and safety standards, not a clinical study involving a test set of medical data for an AI algorithm.

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

   • Not applicable.

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.

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

   • Not applicable.

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

   • Not applicable. The "ground truth" here is the adherence to specifications and safety standards relevant to medical displays.

8. The sample size for the training set:

   • Not applicable.

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

   • Not applicable.

Overall Study Described (for the medical display):

The "study" described is a comparison to a predicate device (MDC2130-2HC 21.3" 2MP Color LCD Monitor by CHILIN Technology Co., Ltd., K063579) to establish substantial equivalence. The document asserts that the new device (L218TJ) "shares the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (UL60601-1) and human factors. It use similar material, and have same compatibility with environment and other device." This comparison is the basis for its clearance, not a clinical performance study with patient data.

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The L218TL Monochrome display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians.

To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display cards.

The L218TL cannot be used for a life-support system.

This device must not be used in digital mammography.

This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.

Medical Display, L218TL is a 21.3" Monochrome LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

The provided text is a 510(k) summary for a medical display monitor (NEC MD213 MG / L218TL). This type of document focuses on establishing substantial equivalence to a predicate device, primarily through comparing technical specifications and safety standards, rather than detailing a rigorous clinical study of acceptance criteria and device performance in the way an AI algorithm or diagnostic tool would.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) are not applicable to this submission, as it relates to a hardware display device and not a diagnostic software or AI.

However, I can extract the relevant information from the document as best as possible within the context of a hardware device submission.

Acceptance Criteria and Study for NEC MD213 MG (L218TL) Medical Display

As this submission is for a medical display monitor, the "acceptance criteria" and "device performance" primarily revolve around technical specifications and regulatory compliance demonstrating substantial equivalence to a predicate device. A clinical study with specific diagnostic performance metrics (e.g., sensitivity, specificity for disease detection) and reader performance improvement is not typically performed for a display monitor.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The "study" in this context is a substantial equivalence comparison to a legally marketed predicate device, MDM2130-3NC 21.3" 3MP Monochrome LCD Monitor by CHILIN Technology Co., Ltd. (K063266). The entire submission argues that the NEC L218TL device is substantially equivalent to this predicate based on shared design, performance, safety standards, and intended use.

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

• Not Applicable (N/A). This is a hardware device submission. There is no "test set" of patient data or images in the typical sense for evaluating diagnostic performance. The evaluation is based on the device's technical specifications and compliance with established safety and performance standards relevant to medical monitors.

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

• Not Applicable (N/A). No "ground truth" was established from expert consensus on medical images for this hardware device.

4. Adjudication Method for the Test Set:

• Not Applicable (N/A). No adjudication methods for diagnostic performance were employed.

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 (N/A). This is not an AI-assisted diagnostic device. It is a display monitor.

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

• Not Applicable (N/A). This is a display monitor, not an algorithm.

7. The Type of Ground Truth Used:

• Not Applicable (N/A). For a medical display monitor, the "ground truth" is typically defined by adherence to objective performance standards (e.g., DICOM Part 14 Grayscale Standard Display Function compliance, luminance, contrast, resolution, uniformity) and safety standards (e.g., IEC 60601-1, EN 60601-1-2, UL 60601-1). The document states that the device meets these safety and performance requirements through comparison to the predicate device.

8. The Sample Size for the Training Set:

• Not Applicable (N/A). There is no "training set" as this is a hardware device.

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

• Not Applicable (N/A). There is no "training set" or corresponding ground truth for a hardware display device.

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The L307TD Color display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians.

To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards.

TheL307TD cannot be used for a life-support system.

This device must not be used in digital mammography.

This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.

Medical Display, L307TD is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

Here's an analysis of the provided text regarding the NEC L307TD Medical Display, focusing on acceptance criteria and study details.

Based solely on the provided document (K083916 510(k) Summary), the information requested about acceptance criteria and a detailed study proving performance is not explicitly contained.

This 510(k) summary is for a medical display monitor, not an AI algorithm or a diagnostic device that performs interpretations. Therefore, the "acceptance criteria" discussed are largely related to electrical safety, mechanical safety, human factors, and display performance specifications (e.g., resolution, gamma grayscale adjustment) to ensure it's suitable for displaying medical images, rather than diagnostic accuracy metrics like sensitivity or specificity. The "study" proving performance is a substantial equivalence comparison to a predicate device, not a clinical trial involving human readers or a standalone algorithm.

Here's how to address your points based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with numerical performance data in the way one would expect for an AI diagnostic device. Instead, the basis for acceptance is a demonstration of equivalence to a legally marketed predicate device (MDC2130-2HC by CHILIN Technology Co., Ltd. - K063579) across various characteristics.

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

• Not Applicable / Not Provided: For a medical display monitor's 510(k) submission based on substantial equivalence, there isn't a "test set" of medical images or patient data in the context of diagnostic accuracy. The testing involves engineering and safety evaluations against standards and comparison to a predicate device's specifications. The document does not mention any medical image datasets being used for testing or evaluation of diagnostic performance.

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

• Not Applicable / Not Provided: As there is no diagnostic "test set" of patient cases for interpretation, there are no experts establishing ground truth for such a set. The "ground truth" for a display monitor relates to engineering specifications and safety compliance.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided: No diagnostic test set, therefore no adjudication method for ground truth.

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 document is for a medical display monitor. MRMC studies are relevant for diagnostic algorithms or systems that assist human readers in making diagnoses. This device simply provides the visual interface.

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

• No: This device is a display monitor, not an algorithm.

7. The type of Ground Truth Used

• Engineering Specifications and Regulatory Standards: The "ground truth" in this context refers to established technical specifications (e.g., resolution, grayscale accuracy, contrast, brightness) and compliance with electrical, mechanical, and radiation safety standards (e.g., IEC60601-1, UL60601-1, EN60601-1-2).

8. The Sample Size for the Training Set

• Not Applicable / Not Provided: As this is a display monitor, there is no "training set" in the context of machine learning or diagnostic algorithms.

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

• Not Applicable / Not Provided: No training set exists for this type of device.

Summary of the Study Proving Device Meets Acceptance Criteria (as per K083916):

The "study" proving the device meets its "acceptance criteria" is a substantial equivalence demonstration to a legally marketed predicate device (MDC2130-2HC by CHILIN Technology Co., Ltd. - K063579).

The manufacturer (NEC Display Solutions Ltd.) states that the L307TD Medical Display is substantially equivalent to its predicate because:

• They have the same intended use: displaying digital image diagnosis by trained physicians.
• They share the same design, performance characteristics (e.g., 4 megapixel resolution, adjustable gamma), and are the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (UL60601-1), and human factors.
• They use similar material.
• They have the same compatibility with environment and other devices.
• They serve the same target population of trained practitioners in a hospital setting.

This 510(k) summary (K083916) does not detail specific experiments, clinical trials, or performance metrics beyond the general statement of equivalence and the device's technical specifications relevant to its function as a display monitor. The FDA's 510(k) clearance process determined that the device is "substantially equivalent" to the predicate, meaning it is as safe and effective as the predicate device.

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The L217TG Color display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards. The L217TG cannot be used for a life-support system. This device must not be used in digital mammography. This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.

Medical Display, L217TG is a 21.3" Color LCD monitor that displays image for medical use. I It provides 2 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

The provided text describes a 510(k) premarket notification for a medical display device, the NEC MD212 MC 21.3" Diagnostic Imaging LCD monitor (Model L217TG). The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria in a typical clinical performance study sense.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a dedicated performance study for the device's diagnostic capabilities. Instead, it relies on demonstrating substantial equivalence to a predicate device (MDC2130-2HC 21.3" 2MP Color LCD Monitor by CHILIN Technology Co., Ltd.) based on shared design, performance, and safety characteristics.

The "performance" referred to is about the characteristics of the monitor itself, not a clinical diagnostic performance.

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

This document does not describe a "test set" in the context of clinical performance evaluation with patient data. The evaluation is for an imaging display device, not an AI algorithm or a diagnostic test directly analyzing patient images. Therefore, questions regarding data provenance and retrospective/prospective studies are not applicable in this context. The "test" would involve technical specifications and safety compliance for the monitor itself.

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

Not applicable. This is a technical device submission, not a study evaluating diagnostic performance against a ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

No. This document pertains to a medical display device, not an AI system. Therefore, an MRMC study and AI-related effect sizes are not applicable.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No. This is a medical display device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for a medical display device would be its technical specifications and compliance with safety standards, not a diagnostic outcome.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm or a device that "learns" from a training set of data.

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

Not applicable for the reasons stated above.

Summary of the Study/Evaluation Process for K083907:

The "study" in this context is a substantial equivalence determination process. The manufacturer (NEC Display Solutions Ltd.) compared their new device, the L217TG medical display, to an already legally marketed predicate device (MDC2130-2HC by CHILIN Technology Co., Ltd. K063579).

The key argument for acceptance (or substantial equivalence) is presented in section 7 ("CONCLUSION"):

• Comparison Basis: The two devices have the "same target population of trained practitioner in hospital."
• Shared Characteristics: They share "the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (UL60601-1) and human factors." They also use "similar material" and have "same compatibility with environment and other device."
• Intended Use: Both devices have the "same intended use."
• Evidence: A "Comparison table of the principal characteristics of two devices is shown in the Section 3, table 3.3" (though Section 3 itself is not provided in your input, the summary implies the comparison was successful).

Therefore, the device meets its "acceptance criteria" by demonstrating that its technical specifications, safety profile, and intended use are functionally identical or very similar to a legally marketed predicate device, as required for a 510(k) clearance.

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The L218TK Color display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians.

To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards.

TheL218TK cannot be used for a life-support system.

This unit is designed for exclusive interconnection with IEC60601 -1 certified equipment.

Medical Display, L218TK is a 21.3" Color LCD monitor that displays image for medical use. It provides 2 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

This document is a 510(k) Summary of Safety and Effectiveness for a medical display, the NEC MD21M 21.3" Diagnostic Imaging LCD monitor (Model L218TK). It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI algorithm would.

Instead, the "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to the predicate device and meeting general performance expectations for a diagnostic display. The "study" proving it meets these is the comparison to the predicate device and the inherent design specifications of the display unit.

Here's the breakdown based on the provided text, recognizing the limitations of a 510(k) for a display device vs. an AI algorithm:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a medical display and not an AI algorithm, the "acceptance criteria" are not explicitly listed in a quantitative fashion that would typically be found in an AI performance study. Instead, the general acceptance criteria are implicit:

• Intended Use Equivalence: The device's intended use must be substantially equivalent to the predicate device.
• Technological Characteristics Equivalence: The device must share similar technological characteristics, or any differences must not raise new questions of safety or effectiveness.
• Display Performance: The display must be capable of showing digital images for diagnosis by trained physicians, including specific resolution and adjustable gamma grayscale, as stated in the description.
• Safety Standards: Compliance with relevant safety standards (e.g., IEC60601-1 for interconnection).

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) for a display device. There isn't a "test set" of medical images or patient data in the way there would be for an AI algorithm. The evaluation is on the hardware's specifications and its equivalence to a predicate device.
• Data Provenance: Not applicable.

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

• Not applicable. Ground truth for medical image interpretation by experts is not established for a display monitor's 510(k). The regulatory body (FDA) reviews technical specifications and equivalence claims.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" requiring adjudication in this context.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of a new diagnostic method or AI on human reader performance, which is not relevant for a display screen's 510(k) submission.

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

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

7. The Type of Ground Truth Used

• Not applicable. For a display device, the "ground truth" would relate to its physical and performance specifications (e.g., luminance, contrast, resolution, color accuracy), which are verified through engineering testing and comparison to industry standards and the predicate device, not necessarily against clinical ground truth like pathology for an AI.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" as it is a hardware display, not an AI algorithm.

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

• Not applicable.

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The MD205MG-1 grayscale display is intended to be used for displaying and viewing of digital image diagnosis including digital mammography by trained physicians.

To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards.

The MD205MG-1 cannot be used for a life-support system.

This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.

Medical Display, MD205MG-1 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, and PACS.

The provided text is a 510(k) summary for a medical display device, the NEC Medical Display, MD205MG-1. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics in the way a clinical trial or AI algorithm validation study would.

Therefore, much of the requested information (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details) is not applicable or not present in this type of regulatory submission.

Here's what can be extracted based on the provided text:

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

This document describes a device (a medical display monitor) and its intended use, rather than a diagnostic algorithm or a device with specific performance metrics like sensitivity or specificity. The "acceptance criteria" here refer to conformity with established standards for medical devices and displays, and "device performance" refers to its technical specifications matching the predicate device or meeting those standards.

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

• Sample Size: Not applicable. This is a hardware conformity assessment, not an algorithmic performance study on a test dataset of images/patients.
• Data Provenance: Not applicable for an "algorithm test set." The device itself (the monitor) underwent testing against compliance standards.

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

• Not applicable. There is no "ground truth" for a test set of medical cases/images in this context, as it's a display monitor. The compliance standards themselves form the basis of evaluation.

4. Adjudication method for the test set

• Not applicable. No adjudication method for medical cases is described.

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 hardware device (a display monitor), not an AI algorithm. Therefore, no MRMC study, AI assistance, or effect size is relevant or mentioned.

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

• Not applicable. This is a hardware device.

7. The type of ground truth used

• Not applicable in the context of clinical "ground truth" from pathology, expert consensus, or outcomes data. The "ground truth" for this device's evaluation is its adherence to technical specifications, safety standards (UL60601-1, EN60601-1-2, etc.), and functional equivalence to the predicate device.

8. The sample size for the training set

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

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

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

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