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CL-S301 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.

21.3 inch Color LCD Monitor
1536 x 2048 (portrait)
High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display. Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable. Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor. Luminance and the color mura correction functions will help achieve uniformity on the whole screen.

The provided FDA 510(k) summary is for a medical monitor (3MP Color LCD Monitor CL-S301), not an AI device. Therefore, much of the requested information regarding AI device acceptance criteria, study design, and performance metrics (e.g., sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies) is not applicable or cannot be extracted from this document, as it pertains to the performance evaluation of a display hardware.

However, I can extract the acceptance criteria and performance data related to the physical characteristics of the monitor, as well as general information about its intended use and comparison to a predicate device.

Here's the available information based on the provided text:

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

The document presents performance "test items in the guidance" which serve as acceptance criteria for a medical display monitor. The "test method(s)" column describes how these criteria are verified. The conclusion states that "The results of the performance testing and the verification demonstrate that the subject device is substantially equivalent to the currently marketed predicate device." This implicitly means the device met the acceptance criteria for each test.

2. Sample sized 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 to a physical display device. The tests are performed on the device itself, not on
a "data set" in the context of an AI algorithm. The device manufacturer is JVCKENWOOD Corporation, located in Japan.

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)

This is not applicable. The "ground truth" for a monitor's performance is based on physical measurements and adherence to technical standards (e.g., ISO, IDMS, AAPM-TG directives), not expert interpretation of medical images.

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

This is not applicable. Adjudication methods are relevant for evaluating expert performance on diagnostic tasks, not for physical device testing.

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

This is not applicable. An MRMC study is used to evaluate the diagnostic performance of a system (often AI-assisted) with human readers. This document describes a monitor, which is a display hardware, not a diagnostic AI system.

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

This is not applicable as the device is a display monitor, not an algorithm.

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

The "ground truth" for the monitor's performance is defined by adherence to established technical standards and measurement protocols (e.g., ISO 13406-2, IDMS 1.03, AAPM-TG18/196, IEC 62563-1).

8. The sample size for the training set

This is not applicable. The device is a physical monitor, not an AI algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

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C510S, G510S, CB5MP, MB5MP, C516S and G516S are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

5MP LCD Monitors C510S, G510S, CB5MP, MB5MP, C516S, G516S are 21.3-inch TFT LCD monitors, which are specifically designed to provide the high definition image output for general radiography. These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 2560 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable and the calibration is continuous, so these products meet the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

The provided text describes a 510(k) premarket notification for medical display monitors and does not contain information about the acceptance criteria and study proving device meets the criteria. This document focuses on demonstrating substantial equivalence to a predicate device through comparison tables and performance testing rather than defining acceptance criteria and presenting a study with specific performance metrics against those criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets the acceptance criteria based on the provided text.

Here's why the requested information is not available:

1. Acceptance Criteria and Reported Device Performance: While the document presents detailed technical specifications of the proposed devices (e.g., resolution, contrast ratio, maximum luminance, DICOM calibrated luminance) and compares them to a predicate device, it does not explicitly state these specifications as "acceptance criteria" against which a study's results are evaluated. The document focuses on showing that the proposed device's characteristics are comparable to or within an acceptable range of the predicate device's characteristics. There is no specific table labeled "acceptance criteria" and "reported device performance."

2. Sample Size and Data Provenance for Test Set: Performance testing was conducted, but the document does not mention a "test set" in the context of clinical images or patient data. The tests are bench tests on the display monitors themselves (e.g., measuring luminance, uniformity, response time). Therefore, there is no sample size for an image-based test set or data provenance (country of origin, retrospective/prospective).

3. Number and Qualifications of Experts for Ground Truth: Since the performance testing comprises bench tests on the display's physical and optical characteristics, there is no "ground truth" derived from expert interpretation of medical images. The evaluation is based on technical measurements.

4. Adjudication Method: Not applicable, as there are no expert interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document explicitly states: "No animal or clinical testing is needed for C510S, CB5MP, MB5MP, C516S, G516S." Therefore, no MRMC study or human reader performance evaluation (with or without AI assistance) was performed.

6. Standalone (Algorithm Only) Performance: This is a medical display monitor, not an AI algorithm. Therefore, standalone algorithm performance is not applicable.

7. Type of Ground Truth Used: The ground truth for the performance testing consists of technical standards and measurements (e.g., DICOM Part 3.14, AAPM TG18 guideline measurements) for display characteristics. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for Training Set: Not applicable. These are display monitors, not an AI model that requires a training set.

9. How Ground Truth for Training Set was Established: Not applicable, as there is no training set.

The document primarily demonstrates substantial equivalence to a predicate device based on technical specifications and adherence to relevant industry standards for display performance in diagnostic radiology, as outlined in the bench tests described.

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These products are indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

The C1216W and C12*** are 12MP color LCD monitors, which are specifically designed to provide the high definition image output for general radiography. They are using the latest generation of LED back light panel, with high resolution 4200 x 2800, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be quaranteed throughout its life. The anti-qlare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

The provided document describes a 510(k) premarket notification for a medical display monitor, the "12MP Color LCD Monitor (C1216W, C12***)". The primary purpose of this document is to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device, the EIZO Corporation's 12MP Color LCD Monitor, RadiForce RX1270 (K200485).

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

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

The document does not explicitly state "acceptance criteria" for performance in a tabular format with corresponding reported device performance. Instead, it details performance testing conducted to demonstrate equivalence to the predicate device. The performance characteristics of the proposed device are compared to the predicate device in several tables (Table 1 Intended Use Comparison, and Table 2 General Comparison, which is spread across pages 7 and 8 but not fully reproduced here with all details).

However, based on the "Performance Testing" section (page 9-10), the implied "acceptance criterion" for each test is that the device should demonstrate characteristics equivalent to those of the predicate device or that any differences do not affect observer performance.

Here's a summary of the performance testing performed, which serves as the basis for demonstrating equivalence:

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

The document describes bench tests that were performed on the device. It does not mention a "test set" consisting of patient data or clinical images. The testing is based on the device itself and its intrinsic technical characteristics. Therefore, there's no information about sample size for a test set in the conventional sense of a clinical or image-based study, nor about data provenance (country of origin, retrospective/prospective). The tests were conducted on the physical devices C1216W and C12***.

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 as the study described is a bench test of a display monitor, not an interpretative study requiring expert ground truth for medical images.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

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 comparative effectiveness study was not done. This submission is for a medical display monitor and does not involve AI assistance or human reader performance evaluation.

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

This information is not applicable as the device is a display monitor, not an algorithm.

7. The type of ground truth used

The concept of "ground truth" as derived from expert consensus, pathology, or outcomes data is not applicable here. The "ground truth" in this context refers to established technical standards and measurement specifications, specifically the AAPM Task Group 18 (TG18 guideline), which outlines procedures for evaluating display performance for medical imaging systems. These standards serve as the reference for evaluating the display's inherent technical characteristics.

8. The sample size for the training set

This information is not applicable as the device is a display monitor and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reason as point 8.

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CL-R813 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel.

It is not meant to be used in digital mammography.

32-inch 8MP Color LCD Monitor CL-R813, 3840 x 2160 (landscape)

• Color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
• Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
• Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
• Luminance mura correction functions will help achieve uniformity on the whole screen.

The provided text describes a 510(k) summary for the JVCKENWOOD 8MP Color LCD Monitor CL-R813. It is a submission for a display device, not an AI/ML medical device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and specific ground truth types like pathology or outcomes data) are not applicable to this document.

However, I can extract information regarding the device's technical performance and the tests conducted to demonstrate its characteristics.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance test items from the "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" and the methods used. It states that the CL-R813 met "predefined criteria" but does not explicitly provide a table of acceptance criteria with numerical thresholds nor does it report specific numerical performance results for the CL-R813 against those criteria. It only states a qualitative finding of equivalence.

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

Not applicable. This is a display device, not an AI/ML algorithm that processes a "test set" of medical images from patients. The testing involved evaluating the physical characteristics of the monitor hardware.

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 an AI/ML algorithm is not relevant for a display hardware submission.

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. This is a display device, not an AI assistance tool for human readers.

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

Not applicable. For a display device, the "ground truth" is typically defined by industry standards and objective physical measurements (e.g., spectral characteristics of light, spatial resolution patterns). The document references standards like ISO, IDMS, AAPM-TG18, and IEC.

8. The sample size for the training set

Not applicable. This device does not involve a training set for an AI/ML algorithm.

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

Not applicable.

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CL-S600 is intended to be used in displaying and viewing medical images for trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.

30 inch Color LCD Monitor 3280 x 2080 (landscape)
High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
Luminance and the color mura correction functions will help achieve uniformity on the whole screen.

The provided text describes a 510(k) premarket notification for a medical LCD monitor (JVCKENWOOD 6MP Color LCD Monitor CL-S600). Since this is a submission for a display device, the acceptance criteria and study information provided are related to the technical performance of the monitor itself, rather than the performance of an AI algorithm or diagnostic accuracy.

Therefore, the response below will focus on the device's technical specifications and the tests conducted to demonstrate compliance and substantial equivalence to a predicate device, as presented in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance test items in the guidance (which can be inferred as acceptance criteria for this type of device) and the methods used to verify compliance. The actual numerical performance results are not explicitly stated in this high-level summary but are implied to have met the relevant standards.

Note: Items g, h, i, j, k, l are marked "N/A" as they are "For mammography displays," and the device is explicitly stated as "not meant to be used in digital mammography." The compliance is "implied" because the document concludes that "The results of the performance testing and the verification demonstrate that the subject device is substantially equivalent to the currently marketed predicate device."

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

The document describes physical laboratory tests on the device itself. Thus, the "sample size" is the single device (JVCKENWOOD 6MP Color LCD Monitor CL-S600) undergoing testing. There isn't a "test set" of patient data in the context of an AI algorithm evaluation. The provenance of the data is the physical testing conducted by the manufacturer, JVCKENWOOD Corporation, in Japan.

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

Not applicable for a medical display device's technical performance testing. Ground truth for display performance is established by objective physical measurements against established industry standards (e.g., ISO, AAPM-TG18, IDMS, IEC).

4. Adjudication Method for the Test Set

Not applicable for technical performance testing of a physical device. Objective measurements are used.

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 display monitor, not an AI algorithm for diagnostic interpretation. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

Not applicable. This device is a medical display monitor, not an AI algorithm. Its performance is inherent in its hardware and firmware capabilities to accurately display images.

7. The Type of Ground Truth Used

The "ground truth" for the device's technical performance is defined by established international and industry standards for medical displays, such as:

• ISO 13406-2 for pixel defects
• AAPM-TG18 for luminance response and artifacts
• IDMS 1.03 (Information Display Measurements Standard) for various display characteristics
• AAPM-TG196 for gray tracking
• IEC 62563-1 for greyscale chromaticity evaluation
• DICOM GSDF (Grayscale Standard Display Function) for luminance characteristics.

These standards provide objective, quantifiable benchmarks for display performance.

8. The Sample Size for the Training Set

No "training set" is applicable for this device. This is a display monitor, not a machine learning model.

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

No "training set" or corresponding ground truth establishment is applicable for this device.

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These products are intended to be used in displaying digital images for review and analysis by trained medical practitioners. They do not support the display of mammography images for diagnosis.

C44W+ is a 30-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for Ultrasound and General Radiography. With built-in multi-display modes, it facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control. 14 bit image processing technology, and interfaces with external calibration software, it ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for erqonomic comfort.

C82W+ is a 31.5-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for diagnostic, interventional radiology and other medical applications. With built-in multi-display modes, it facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control, 14 bit image processing technology, and interfaces with external calibration software, it ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for ergonomic comfort.

C83W+ and C85W+ are 27-inch TFT color LCD monitors. They are specifically designed to provide the high definition images output for general Radiography. The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 3840 x 2160. With built-in brightness stabilization control circuit, make sure the brightness of this monitors are stable in their life, and the products meet the demand of high precision medical imaging.

For C44W+, C82W+, C83W+, C85W+, the only difference is the screen. C83W+ and C85W+ have the same screen, but their customers are different, which results in the two models.

The provided document describes the 510(k) premarket notification for Shenzhen Beacon Display Technology Co., Ltd.'s 4MP/8MP Color LCD Monitors (C44W+/C82W+, C83W+, C85W+). These monitors are intended for displaying digital images for review and analysis by trained medical practitioners, excluding mammography images for diagnosis.

The study presented is a bench test comparison to a legally marketed predicate device, the Eizo Nanao Corporation RadiForce RX440 (K130070). The purpose of the study is to demonstrate substantial equivalence to the predicate device, not necessarily to establish the device's absolute performance against a set of clinical acceptance criteria for diagnosis.

Here is an analysis based on your requested information, referencing the provided document:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study targeting specific diagnostic performance metrics (e.g., sensitivity, specificity). Instead, it focuses on demonstrating equivalence to a predicate device based on technical display characteristics and conformance to relevant industry guidelines (AAPM Task Group 18 (TG18 guideline)).

The "reported device performance" are the results of the bench tests on the proposed devices (C44W+, C82W+, C83W+, C85W+) showing their technical specifications and how they align with or differ from the predicate device. The document generally concludes that the devices are equivalent to the predicate.

Here's a summary of key performance tests conducted, which serve as the basis for their claim of equivalence:

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

The study involves bench testing of the devices themselves (C44W+, C82W+, C83W+, C85W+). It's not a study involving patient data or human interpretation. Therefore, "sample size" and "data provenance" in the context of clinical images or patient data are not applicable. The "test set" consists of the physical display units being evaluated.

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

This is a technical performance study of a device (monitor), not a diagnostic accuracy study using medical images interpreted by experts. Therefore, "ground truth" in the context of expert consensus on medical images is not applicable. The ground truth is adherence to technical specifications and industry standards like AAPM TG18. The "experts" involved would be the technical personnel performing the bench testing and evaluating the results against established standards, but their specific number and qualifications are not mentioned in this document.

4. Adjudication method for the test set

"Adjudication method" is not applicable as this is a technical performance study of display monitors, not an evaluation of diagnostic interpretations where consensus among readers would be required.

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 comparative effectiveness study was not done. This submission is for medical display monitors, not an AI-powered diagnostic tool. The document focuses on the technical characteristics and equivalence of the monitors to a predicate device.

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

This question refers to AI algorithm performance. Since the device is a medical display monitor and not an AI algorithm, a standalone performance study in that context was not done. The study performed was a technical assessment of the monitor's display capabilities.

7. The type of ground truth used

The "ground truth" for this technical assessment is adherence to technical specifications, industry standards (e.g., DICOM 3.14, AAPM TG18 guidelines), and comparison with the predicate device's established performance. It's not based on pathology, expert consensus on medical images, or patient outcomes data.

8. The sample size for the training set

This question refers to the training of an algorithm. Since the device is a medical display monitor and not an AI algorithm, a "training set" is not applicable.

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

This question refers to the training of an algorithm. Since the device is a medical display monitor and not an AI algorithm, the concept of establishing ground truth for a training set is not applicable.

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The 3MP Color LCD Monitors C32S+, C32SP+ are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.

The 3MP Monochrome LCD Monitors G32S+, G32SP+ are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.

3MP Color LCD monitors C32S+, C32SP+; 3MP Monochrome LCD monitors G32S+, G32SP+ are specifically designed to provide the high definition image outputs for general Radiography.

The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panels, supporting resolution 2048 x 1536. The built-in brightness stabilization control circuits make sure the brightness of these monitors are stable in their life and the calibrations are continuous, so the products meet the demands of high precision medical imaging. For the C32SP+ and G32SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen.

Model variations are distinguished by characters. C means the Color monitor, G means the Monochrome monitor, and P means the monitor with an additional glass screen. For example, C32S+ is a color LCD monitor; G32SP+ is a monochrome LCD monitor with the additional glass screen.

The provided document is a 510(k) Pre-Market Notification for medical display monitors (3MP Color LCD Monitors C32S+, C32SP+ and 3MP Monochrome LCD Monitors G32S+, G32SP+). It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against specific clinical acceptance criteria for an AI-powered device.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and training set details) are not applicable or not present in this type of submission. This document describes the technical specifications and bench test results of the monitors themselves, not the performance of an AI algorithm based on image interpretation.

Here's an analysis based on the information available:

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

The document does not explicitly state "acceptance criteria" in a pass/fail table format for an AI algorithm's performance. Instead, it lists technical specifications of the proposed monitors and compares them to predicate devices, along with bench test results to verify compliance with display standards. The performance reported relates to display characteristics, not diagnostic accuracy of an AI.

However, we can infer some "acceptance criteria" based on the comparison tables and testing performed, which are primarily related to meeting technical standards for medical displays.

Note: Specific numerical results for each measurement (e.g., exact luminance non-uniformity values) are not provided in this summary, but the document states they were measured and found to be equivalent to predicate devices.

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 document describes tests on the physical display monitors, not an AI algorithm processing medical images. The "test set" here refers to the monitors themselves.

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)

This information is not applicable. The "ground truth" for these display monitors is defined by technical specifications and adherence to standards like DICOM and AAPM TG18 guidelines, measured by equipment and engineering assessments, not by expert medical image interpretation.

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

This information is not applicable. Adjudication methods are relevant for clinical studies involving human interpretation or AI output, not for technical verification of display monitors.

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

This information is not applicable. This document is for medical display monitors and does not involve AI assistance or MRMC studies for diagnostic performance improvement.

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

This information is not applicable. No algorithm is being evaluated in this submission.

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

The "ground truth" for the performance evaluation of these medical displays is established by adherence to technical and performance standards for display devices, such as DICOM Part 3.14 and AAPM Task Group 18 (TG18 guideline) for display performance. It's measured through physical bench testing and comparison to established engineering specifications and predicate devices.

8. The sample size for the training set

This information is not applicable. There is no AI algorithm with a training set being described in this document.

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

This information is not applicable. There is no AI algorithm with a training set being described in this document.

In summary, the provided text is a 510(k) summary for medical display monitors, focusing on their technical specifications and substantial equivalence to predicate devices, as demonstrated through bench testing against established display standards. It does not contain information related to AI algorithm performance or clinical studies of diagnostic accuracy.

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The 5MP Color LCD Monitors C53S+, C53SP+ and 5MP Monochrome LCD Monitors G53S+, G53SP+ are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

5MP LCD Monitors C53S+, C53SP+, G53S+, G53SP+ are 21.3-inch TFT LCD monitors, which are specifically designed to provide the high definition image output for general radiography. These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 2048 x 2560. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable in their lives and the calibration is continuous, so these products meet the demand of high precision medical imaging. For C53SP+ and G53SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen. Model variations are distinquished by characters. C means the Color monitor, G means the Monochrome monitor, and P means the monitor with an additional glass screen. For example, C53S+ is a color LCD monitor; G53SP+ is a monochrome LCD monitor with the additional glass screen.

The document describes the premarket notification (510(k)) for Shenzhen Beacon Display Technology Co., Ltd.'s 5MP Color and Monochrome LCD Monitors (C53S+, C53SP+, G53S+, G53SP+). However, this document does not contain information about an AI/algorithm-driven device, nor does it detail a study proving adherence to specific acceptance criteria for such a device in the context of AI model performance. Instead, it focuses on the substantial equivalence of the monitors to a predicate device, primarily through bench testing of display characteristics.

Therefore, I cannot provide the requested information as it pertains to an AI/algorithm efficacy study, acceptance criteria for an AI model, sample sizes, expert involvement, or MRMC studies, because this document is about medical display monitors and their technical specifications, not an AI software or algorithm.

The document states:

• Device Type: 5MP Color LCD Monitors C53S+, C53SP+; 5MP Monochrome LCD Monitors G53S+, G53SP+. These are hardware display devices, not AI algorithms.
• Intended Use: "displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM." This reinforces that the device is a display and not an AI component.
• Performance Testing: The "Performance Testing" section (page 16) outlines the tests conducted on the monitors themselves, such as "conformance to DICOM GSDF," "calibrated luminance," "luminance non-uniformity," "chromaticity non-uniformity," "temporal response," "spatial noise," "reflection coefficient," "veiling glare," and "spatial resolution." These are all standard display performance tests.
• No clinical or animal testing: The document explicitly states "No animal or clinical testing is needed for C53S+, C53SP+, G53S+, G53SP+." This further confirms that no studies involving human or animal subjects (which would be typical for evaluating an AI's impact on diagnostic performance) were conducted or required.

The request's parameters (acceptance criteria for an AI model, sample sizes for AI test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to the content of this document.

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CL-S500 and MS-S500 are intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

CL-S500 : 21.3 inch Color LCD Monitor 2048 x 2560 (landscape), 2560 x 2048 (portrait)
High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
It minimizes luminance unevenness and color unevenness by Uniformity Correction Function to achieve the uniformity of luminance and color on the whole screen.
Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC quideline is conducted

MS-S500 : 21.3 inch Monochrome LCD Monitor 2048 x 2560 (landscape), 2560 x 2048 (portrait)
High-luminance monochrome LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
It minimizes luminance unevenness by Uniformity Correction Function to achieve the uniformity of luminance on the whole screen.
Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC guideline is conducted.

The acceptance criteria for the JVC Kenwood CL-S500 (color) and MS-S500 (monochrome) LCD monitors, intended for medical image display in digital mammography PACS, digital breast tomosynthesis, and FFDM, are based on a comparison to a predicate device (CCL550i2/ K160326) and adherence to established display quality standards (AAPM-TG18 and ISO13406-2).

The study primarily focuses on demonstrating substantial equivalence by comparing the technical specifications and performance of the new devices to the predicate device and relevant industry standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" as a separate, quantitative target for each metric beyond direct comparison to the predicate device or a reference to a standard (e.g., AAPM-TG18 passing criteria). However, the "Explanation of Differences" column in the substantial equivalence comparison tables implicitly suggests the acceptance criteria where the new device must be equivalent to or better than the predicate, or meet the requirements of the specified standard.

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The 6MP Color LCD Monitor (C61W+) is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

C61W+ is a 30-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for general radiography. With built-in multi-display modes, the monitor facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control, 14 bit image processing technology, and interfaces with external calibration software, the monitor ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for ergonomic comfort.

The provided text describes the 510(k) summary for the Shenzhen Beacon Display Technology Co., Ltd.'s 6MP Color LCD Monitor (C61W+). It outlines the device's technical specifications and compares it to a predicate device, the EIZO Corporation's 6MP Color LCD Monitor, RadiForce RX650 (K134002).

However, this document does not contain information related to an AI/ML-based medical device study. The device in question is a medical display monitor, and the "acceptance criteria" and "study" described are focused on verifying its display performance characteristics (e.g., DICOM conformance, luminance, chromaticity, pixel defects) against established standards (AAPM TG18 guideline) and demonstrating substantial equivalence to a predicate device.

Therefore, I cannot extract the detailed information requested regarding acceptance criteria and studies that prove the device meets those criteria for an AI/ML product, as the provided text is about a display monitor and not an AI/ML medical device.

The document does mention performance tests done on the monitor to show its equivalence to the predicate device. Here's what can be extracted from the provided text about the monitor's performance testing:

Device: 6MP Color LCD Monitor (C61W+)

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

The document doesn't present precise quantitative "acceptance criteria" in a table format for each test, but it states that "The test results showed that C61W+ is with display characteristics equivalent to those of the predicate device, RadiForce RX650 except some items, each of which was determined that it would not affect observer's performance."

Here's a summary of the performance tests mentioned, which implicitly define the "acceptance criteria" as conforming to the specified standards or demonstrating equivalence to the predicate:

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

• Sample Size: Not specified. The summary implies testing was done on the C61W+ monitor itself, likely one or a few units, rather than a "test set" of images or patient data.
• Data Provenance: Not applicable as it's a display monitor, not an AI/ML algorithm processing data. The tests are physical measurements and visual inspections of the monitor.

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 an AI/ML device, refers to disease presence/absence or other clinical labels. For a display monitor, the "ground truth" is adherence to technical specifications and established display standards (e.g., DICOM GSDF). The "experts" would be the engineers and technicians performing the measurements and visual checks, trained in display calibration and quality control. Their number and specific qualifications are not detailed in this summary.

4. Adjudication method for the test set:

• Not applicable. This concept is relevant for human-in-the-loop or expert consensus for AI/ML algorithm evaluation, not for physical device testing of a monitor.

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 study type is for evaluating the impact of an AI algorithm on human reader performance, which is not relevant for a medical display monitor.

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

• Not applicable. This is for AI/ML algorithms, not for a display monitor. The performance tests mentioned (DICOM conformance, luminance, etc.) are "standalone" in the sense they evaluate the device itself.

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

• The "ground truth" for a medical display monitor is its adherence to industry standards for display quality, such as:
  • AAPM TG18 guideline: For display performance assessment (DICOM GSDF conformance, luminance, chromaticity non-uniformity, artifacts).
  • FDA Staff Guidance: Display Accessories for Full-Field Digital Mammography Systems: For specific chromaticity measurements.
  • Internal specifications for pixel defects/faults.

8. The sample size for the training set:

• Not applicable. There is no AI/ML algorithm being trained for this device.

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

• Not applicable. There is no AI/ML algorithm being trained for this device.

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