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21.3 inch (54 cm) Monochrome 2M pixel LCD Monitor MS23i2 (ML21023) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.

MS23i2 (ML21023) is a 21.3-inch (54 cm) Monochrome LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface) and Display Port.

The provided text describes a 510(k) premarket notification for a medical display monitor and does not concern an AI/ML device or a device that undergoes a clinical study with acceptance criteria in the typical sense of diagnostic performance metrics like sensitivity or specificity.

Therefore, most of the requested information regarding acceptance criteria for device performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies is not applicable to this submission.

The submission is for a 21.3 inch (54 cm) Monochrome LCD Monitor MS23i2 (ML21023) intended for displaying and viewing medical images for diagnosis. The nature of the device means its "performance" is primarily assessed through technical specifications and compliance with relevant standards rather than diagnostic accuracy.

Here's a breakdown of what can be extracted and why other parts are not applicable:

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

   • Not Applicable in the traditional diagnostic sense. This device is a monitor. Its "performance" would be assessed against technical specifications (e.g., resolution, luminance, contrast, uniformity, grayscale reproduction) and compliance with industry standards (e.g., DICOM Part 14 for grayscale display function, IEC 60601-1 for electrical safety). The document does not provide a table with these technical acceptance criteria or reported performance values. It only states the display resolution (1200 x 1600 / 1600 x 1200) and that it is a monochrome 2M pixel LCD monitor.

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

   • Not Applicable. As this is a display monitor, there is no "test set" of medical images in the context of evaluating a diagnostic algorithm's performance. The evaluation would be based on the physical characteristics and software functionality of the monitor itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable. No ground truth establishment related to diagnostic accuracy is relevant for a medical display monitor.

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

   • Not Applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not Applicable. This is a hardware device (monitor), not an AI-assisted diagnostic tool.

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

   • Not Applicable. There is no algorithm in this product that would be evaluated in a standalone capacity.

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

   • Not Applicable.

8. The sample size for the training set

   • Not Applicable. There is no algorithm to train.

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

   • Not Applicable.

Summary based on available information:

The K113443 submission for the TOTOKU MS23i2 (ML21023) monitor is a 510(k) premarket notification for a medical display device. The "study" proving it meets acceptance criteria typically involves demonstrating that the device's technical specifications and performance meet established standards for medical monitors and are substantially equivalent to a predicate device.

• Intended Use: To be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
• Predicate Device: 21.3 inch (54 cm) Monochrome LCD Monitor MS21i2 (MDL2127A) (K081945).
• Substantial Equivalence: The applicant states that the MS23i2 (ML21023) shares the same characteristics with its predicate device MS21i2 (K081945) except for the main board and power supply. This means the primary "study" involved comparing the technical specifications and, presumably, testing the performance aspects (like luminance, contrast, resolution, DICOM conformance) of the new device against the predicate and relevant standards.

Without further information from the full 510(k) submission, specific technical acceptance criteria and their measured values for items like luminance, uniformity, or DICOM conformance cannot be provided. However, the nature of the device means these are the types of criteria that would be assessed.

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21.3 inch (54 cm) Color 2M pixel LCD Monitor CCL256i2 (CL21256) is intended to be used in displaying and viewing medical images for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.

CCL256i2 (CL21256) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface) and Display Port.

This document is a 510(k) summary for a medical device called the "TOTOKU 21.3 inch (54 cm) Color LCD Monitor CCL256i2 (CL21256)". It is a notification to the FDA of the intent to market the device, claiming substantial equivalence to a predicate device.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical testing.

This document is primarily a regulatory submission for a display monitor intended for viewing medical images. The substantial equivalence claim is based on the device sharing the same characteristics as a predicate device (CCL254i2, K081055) except for the power supply.

Therefore, I cannot provide the requested information from the given text.

Here's why:

• No acceptance criteria: The document lists the device's technical specifications (e.g., screen size, resolution, interfaces) and its intended use, but it does not specify any measurable performance targets or thresholds that would typically be described as "acceptance criteria" for image quality, accuracy, or other clinical metrics.
• No study details: Since it's a display monitor, performance studies would typically involve evaluating factors like luminance, contrast ratio, uniformity, color accuracy, viewing angle, and stability, often against industry standards (e.g., DICOM Part 14, AAPM TG-18). This document does not describe any such study, its methodology, results, sample sizes, expert involvement, or ground truth.

In the context of the provided document, the "study that proves the device meets the acceptance criteria" would likely refer to internal testing performed by the manufacturer to ensure the display meets its own design specifications and relevant industry standards for medical image viewing. However, none of that information is included in this 510(k) summary.

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20.8 inch Monochrome Digital Mammography 3M pixel LCD Monitor with sub-pixel driving techniques enabling 9M subpixels to be driven independently, MS33i2 (ML21033) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

MS33i2 (ML21033) is a 20.8-inch monochrome LCD monitor whose display resolution is 1536 x 2048 (landscape), 2048 x 1536 (portrait) supporting DVI (digital visual interface) and DisplayPort.

This document is a 510(k) summary for a medical device called the "20.8 inch Monochrome Digital Mammography LCD Monitor MS33i2 (ML21033)" by TOTOKU ELECTRIC CO., LTD. It's a display monitor intended for viewing medical images for diagnosis, specifically in digital mammography PACS and modalities.

Based on the provided text, the device is a monitor, not an AI/algorithm-powered diagnostic tool. Therefore, the questions related to AI performance, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable. The substantial equivalence is based on device characteristics rather than diagnostic performance.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a display monitor and not a diagnostic algorithm, typical performance metrics like sensitivity, specificity, or AUC as seen in AI studies are not relevant. The substantial equivalence is based on technical specifications and intended use comparison with a predicate device.

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

Not applicable. This is a medical device monitor, not a diagnostic algorithm that processes patient data. The evaluation for substantial equivalence would involve technical testing of the monitor's performance characteristics (e.g., luminance, contrast, resolution) rather than a test set of medical images with ground truth.

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 diagnostic accuracy is not established for a monitor.

4. Adjudication method for the test set

Not applicable. Adjudication methods are used in studies involving diagnostic interpretations of images, which is not the primary evaluation for a display 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

Not applicable. The device is a monitor, not an AI tool.

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

Not applicable. The device is a monitor, not an algorithm.

7. The type of ground truth used

Not applicable. The concept of "ground truth" as it pertains to diagnostic accuracy studies is not relevant for a display monitor's regulatory clearance. The "ground truth" for a monitor would relate to its physical specifications and imaging performance standards.

8. The sample size for the training set

Not applicable. The device is a monitor, not a machine learning model requiring a training set.

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

Not applicable. The device is a monitor, not a machine learning model.

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21.3 inch (54 cm) Color 3M pixel LCD Monitor CCL356i2 (CL21356) is intended to be used in displaying and viewing medical images for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.

CCL356i2 (CL21356) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1536 x 2048 (landscape), 2048 x 1536 (portrait) supporting DVI (digital visual interface) and Display Port.

The provided text describes a 510(k) summary for a medical display device, the TOTOKU 21.3 inch (54 cm) Color LCD Monitor CCL356i2 (CL21356). It is not a document describing a study for a new AI/ML-based medical device. Therefore, the information required to answer the prompt regarding acceptance criteria and the study proving the device meets these criteria (such as performance metrics, sample sizes, ground truth establishment, or multi-reader multi-case studies) is not present in the provided text.

The document states: "CCL3562 (CL21356) shares the same characteristics with our predicate device CCL354i2 (K081056) except for the power supply." This indicates that the device's acceptance criteria are primarily based on equivalence to a previously cleared predicate device, rather than explicit performance metrics derived from a clinical or technical study on image interpretation or diagnostic accuracy involving AI.

Therefore, I cannot populate the table or answer the specific questions about performance studies, expert involvement, or adjudication methods based on the provided text. The document is a regulatory submission for a display monitor, not an AI/ML-driven diagnostic tool.

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21.3 inch (54cm) Monochrome Digital Mammography 5M pixel LCD Monitor with subpixel driving techniques enabling 15M subpixels to be driven independently, MS53i2 (ML21053) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

MS53i2 (ML21053) is a 21.3-inch (54 cm) monochrome LCD monitor whose display resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface).

The provided text describes a medical device, a monochrome digital mammography LCD monitor, and its regulatory clearance process through a 510(k) submission. However, it does not contain any information about acceptance criteria, clinical studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device in a diagnostic context.

The document is a US FDA 510(k) summary and clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study with specific acceptance criteria as you've requested.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study design because that information is not present in the provided text.

The information available is:

• Device Name: 21.3 inch (54 cm) Monochrome Digital Mammography LCD Monitor MS53i2 (ML21053)
• Intended Use: "displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM."
• Predicate Device: 5M Monochrome Digital Mammography LCD Monitor ME551i2 (MDL2116A) (K061447).
• Reason for Substantial Equivalence: Shares the same characteristics with the predicate device "except for the LCD panel and the power supply."

To answer your questions, details from a performance study demonstrating the diagnostic capabilities of the monitor would be required, which are not included in this regulatory summary.

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20.1-inch (51cm) Color LCD Monitor CCL208 (CDL2013A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.

CCL208 (CDL2013A) is a 20.1-inch (51 cm) Color LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface).

This document is a 510(k) summary for the TOTOKU 20.1-inch (51 cm) Color LCD Monitor CCL208 (CDL2013A), a medical display device. The primary purpose of the submission is to demonstrate substantial equivalence to a predicate device.

The document does not describe any study that proves the device meets specific acceptance criteria in terms of performance for image interpretation or diagnostic accuracy. This is because the device is a monitor, and its "performance" is primarily related to display characteristics and technical specifications rather than diagnostic performance.

Therefore, many of the requested elements for a study proving device performance are not applicable to this submission. I will provide the information that is available in the document.

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

The document does not explicitly state "acceptance criteria" in the context of diagnostic performance that would typically be described with metrics like sensitivity, specificity, accuracy, etc. Instead, the substantial equivalence argument relies on meeting technical specifications comparable to the predicate device.

The "performance" of this device is implicitly its ability to display medical images. The acceptance criteria would be that it functions as a display comparable to its predicate. The document states:
"CCL208 (CDL2013A) shares the same characteristics with our predicate devices, CCL202 (CDL2005A) (K063198) except for power supply, LCD panel, main board (driver board and sub board), tilt-stand, I/O position and inverter PWB for LCD backlight."

This implies that despite these component changes, the performance (i.e., its function as a display) is considered equivalent. The common elements like intended use for "displaying and viewing medical images for diagnosis" are the basis for equivalence.

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

Not applicable. This is not a study assessing diagnostic performance on a dataset of medical images. The "test set" would refer to the monitor itself undergoing technical evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this is not a diagnostic performance study where ground truth needs to be established by experts.

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

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a monitor, not an AI or a diagnostic aid that would participate in an MRMC study.

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

Not applicable. This is a hardware device (monitor), not an algorithm.

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

Not applicable. The ground truth for a monitor would be its technical specifications meeting design requirements, not a diagnostic ground truth.

8. The sample size for the training set

Not applicable. This is not a machine learning device that requires a training set.

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

Not applicable.

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21.3 inch (54cm) Monochrome Digital Mammography 3M pixel LCD Monitor with subpixel driving techniques enabling 9M subpixels to be driven independently, MS3112 (MDL2128A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

MS31i2 (MDL2128A) is a 21.3-inch (54 cm) monochrome LCD monitor whose display resolution is 1536 x 6144 (landscape), 6144 x 1536 (portrait) supporting DVI (digital visual interface).

This document focuses on the 510(k) summary for the TOTOKU MS31i2 (MDL2128A) monochrome digital mammography LCD monitor. This device is a display monitor and, as such, does not undergo the same type of performance studies (e.g., diagnostic accuracy studies with human readers, AI algorithms, and clinical outcomes) as a diagnostic imaging device or an AI-powered diagnostic algorithm.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context will refer to the technical specifications and standards that a medical display monitor must meet to be considered safe and effective for its intended use, particularly for mammography. The 510(k) summary provided here does not detail a clinical study with patients, readers, or AI algorithms; rather, it asserts substantial equivalence to predicate devices based on technical characteristics.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details, ground truth for training set) are not applicable or not provided in the context of a 510(k) for a display monitor.

Here's an interpretation based on the provided document and general understanding of medical display regulatory submissions:

Acceptance Criteria and Device Performance for TOTOKU MS31i2 (MDL2128A)

This 510(k) summary for the TOTOKU MS31i2 (MDL2128A) monitor focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific clinical performance study with defined acceptance criteria for diagnostic accuracy. For a display monitor, acceptance criteria are typically related to its physical and performance specifications that ensure images are displayed accurately and consistently for medical diagnosis, especially in demanding fields like mammography.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the acceptance criteria are implicitly tied to the performance characteristics being equivalent to the predicate devices and meeting relevant standards for display of medical images. Specific quantitative acceptance criteria are not detailed in this summary, but the device description highlights key specifications.

Study to Prove Acceptance Criteria:

The "study" to prove the device meets acceptance criteria in this context is the substantiation of substantial equivalence to legally marketed predicate devices, ME551i2 (K061447) and MS51i2 (K071794). This involves demonstrating that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness.

For medical display monitors, this typically involves:

• Technical Bench Testing: Verifying that the monitor meets its published specifications (e.g., luminance, contrast ratio, uniformity, color stability for color displays, resolution, grayscale reproduction accuracy according to DICOM Part 14 standard).
• Compliance with Standards: Demonstrating adherence to relevant industry and regulatory standards for medical devices and displays (e.g., DICOM Part 14, IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility).
• Comparison to Predicate Device Specifications: A direct comparison of the technical specifications of the new device against the predicate device to establish equivalence.

The 510(k) summary itself states: "MS31i2 (MDL2128A) shares the same characteristics with our predicate device ME551i2 (K061447) and MS51i2 (K071794)." This statement is the core of the "proof" from the regulatory perspective provided in this document.

Regarding the specific questions that are not directly applicable to a display monitor 510(k) from the provided text:

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

• Not applicable / Not provided. This device is a display monitor, not a diagnostic algorithm or imaging system that processes patient data. The "test set" would refer to a set of technical tests on the display hardware itself, not a dataset of patient images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. Ground truth, in the sense of clinical diagnoses or pathology, is not established for a display monitor. Technical experts and engineers would evaluate the monitor's performance against technical specifications.

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

• Not applicable / Not provided. Adjudication is relevant for clinical studies where multiple readers interpret images.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a monitor, not an AI-assisted diagnostic tool.

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

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

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

• Not applicable / Not provided. The "ground truth" for a display monitor's performance would be objective measurements against technical standards (e.g., luminance measurements, spatial resolution charts, grayscale step tests), not clinical ground truth.

8. The sample size for the training set

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

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

• Not applicable. This device is a monitor.

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21.3-inch (54cm) Monochrome LCD Monitor with sub-pixel driving techniques enabling 6M subpixels to be driven independently, MS21i2 (MDL2127A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.

MS21i2 (MDL2127A) is a 21.3-inch (54 cm) Monochrome LCD monitor whose display resolution is 1200 x 4800 (landscape), 4800 x 1200 (portrait) supporting DVI (digital visual interface).

The provided text describes a 510(k) premarket notification for a medical display device, the TOTOKU ELECTRIC CO., LTD. 21.3-inch (54 cm) Monochrome LCD Monitor MS21i2 (MDL2127A).

This document focuses on regulatory approval based on "substantial equivalence" to predicate devices, rather than a detailed study evaluating the device's diagnostic performance against specific acceptance criteria. Therefore, most of the requested information (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, etc.) is not available in the provided text, as it describes a display monitor and not an AI-powered diagnostic device.

Here's an attempt to answer the questions based on the available information and, where information is missing, to state that the information is not provided.

Device: TOTOKU ELECTRIC CO., LTD. 21.3-inch (54 cm) Monochrome LCD Monitor MS21i2 (MDL2127A)

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

For a medical display monitor like the MS21i2 (MDL2127A), acceptance criteria are typically related to display characteristics and regulatory compliance, ensuring it can accurately present medical images for diagnosis. The provided document does not explicitly list a table of performance criteria and results from a clinical study for this device, as it is a display monitor. The substantial equivalence argument implies that its performance is comparable to already-approved monitors.

Implicit Acceptance Criteria (inferred from device type and regulatory context):

• Color/grayscale uniformity | Satisfies industry standards for medical displays, comparable to predicate devices. |
  | Resolution | - Display resolution of 1200 x 4800 (landscape) / 4800 x 1200 (portrait) | Achieves stated resolution (1200 x 4800 / 4800 x 1200). |
  | Luminance & Contrast | - Maximum luminance
• Minimum luminance
• Contrast ratio
• Compliance with DICOM Part 14 Grayscale Standard Display Function | Comparable to predicate devices, suitable for diagnostic image viewing. |
  | Calibration Stability | - Long-term stability of display characteristics | Comparable to predicate devices. |
  | Viewing Angle | - Acceptable image quality across typical viewing angles | Comparable to predicate devices. |
  | Dead/Stuck Pixels | - Acceptable limits for pixel defects | Comparable to predicate devices. |
  | Input Compatibility | - Supports DVI (digital visual interface) | Supports DVI. |
  | Regulatory Compliance | - Meets FDA general controls
• Electromagnetric compatibility (EMC)
• Electrical safety | Compliant with relevant standards, as per 510(k) clearance. |

Study to prove acceptance criteria: The 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices (ME253i2 (MDL2121A) (K063198) and MS51i2 (MDL2123A) (K081242)). For a display monitor, this typically involves technical comparisons and testing against recognized industry standards (e.g., DICOM Part 14, IEC standards for medical electrical equipment) rather than clinical studies with human readers or AI algorithms. The document explicitly states: "MS21i2 (MDL2127A) shares the same characteristics with our predicate devices, ME253i2 (MDL2121A) (K063198) and MS51i2 (MDL2123A) (K081242) except for bezel, enclosure and main board (driver board)." This indicates that the justification for meeting acceptance criteria is largely based on the established safety and performance of the 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)

• Not Applicable / Not Provided. This information would be relevant for a diagnostic algorithm or a clinical study. For a display monitor, validation focuses on technical specifications and substantial equivalence, not a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable / Not Provided. Ground truth establishment by experts is not described for a display monitor.

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

• Not Applicable / Not Provided. Adjudication methods are not described for a display 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

• Not Applicable / Not Provided. This device is a display monitor, not an AI or CAD system. Therefore, an MRMC study comparing human readers with AI assistance is not relevant to this submission.

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

• Not Applicable / Not Provided. This device is a display monitor, not a standalone algorithm.

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

• Not Applicable / Not Provided. Ground truth, in the context of clinical accuracy for an AI/diagnostic device, is not defined for a display monitor. The "ground truth" for a display monitor's performance would be its conformity to technical specifications and industry standards.

8. The sample size for the training set

• Not Applicable / Not Provided. This device is a display monitor, not an AI system that requires a training set.

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

• Not Applicable / Not Provided. This device is a display monitor, not an AI system that requires a training set with established ground truth.

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21.3-inch (54cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.

CCL254i2 (CDL2125A) is a 21.3-inch (54cm) 2 megapixel Color LCD monitor that supports DVI video signal and provides UXGA (1200 x 1600) resolution for both landscape and portrait display.

This document describes the 510(k) summary for a medical display device, the 21.3-inch (54 cm) 2M Color LCD Monitor CCL254i2 (CDL2125A). The information provided is primarily focused on the device's technical specifications and its substantial equivalence to a predicate device, rather than a detailed clinical study demonstrating its performance in a diagnostic context.

Therefore, much of the requested information regarding clinical study methodology (sample size, expert qualifications, adjudication, MRMC studies, training set details) is not available in the provided text, as it doesn't describe such a study for this display monitor. The acceptance criteria and "reported device performance" are more about the display's technical capabilities validating its suitability for medical imaging rather than a direct measure of diagnostic accuracy.

Here's the information that can be extracted or reasonably inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This document does not describe a clinical test set or diagnostic study involving a sample of patient data. The "study" here refers to the technical validation of the display monitor itself against predetermined specifications and comparison to a predicate 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 mention of experts establishing ground truth for a test set in the context of a diagnostic study for this device. The assessment revolves around the monitor's technical compliance and substantial equivalence to a predicate.

4. Adjudication method for the test set

• Not Applicable. No test set or adjudication method for diagnostic performance 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

• No. This is a passive display monitor, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• No. This is a display monitor, not an algorithm. Its performance is evaluated based on its display characteristics.

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

• Not Applicable in the traditional sense of a diagnostic study. For this device, the "ground truth" would be the required technical specifications for medical display monitors and the performance characteristics of the predicate device (K063199). The device's performance is measured against these technical standards.

8. The sample size for the training set

• Not Applicable. As a display monitor, there is no AI algorithm being trained, and thus no training set.

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

• Not Applicable. Refer to point 8.

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21.3-inch (54cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.

CCL354i2 (CDL2126A) is a 21.3-inch (54cm) 3 meqapixcel Color LCD monitor that supports DVI video signal and provides UXGA (1536 x 2048) resolution for both landscape and portrait display.

This document describes the 510(k) summary for the TOTOKU ELECTRIC CO., LTD. 21.3-inch (54 cm) 3M Color LCD Monitor CCL354i2 (CDL2126A). This submission establishes substantial equivalence to a predicate device and does not detail a study proving the device meets specific acceptance criteria in the sense of a clinical performance study with defined metrics like sensitivity, specificity, or reader agreement.

The device is a medical image display monitor. For such devices, acceptance criteria typically relate to technical performance specifications (e.g., luminance, contrast, resolution, uniformity, color accuracy) rather than diagnostic performance in a clinical study. The provided text does not include a table of acceptance criteria or a study proving the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on shared characteristics.

Therefore, many of the requested details, such as sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training/test sets, are not applicable or not provided in this regulatory submission for a display monitor.

Here's a response based on the information provided in the input:

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

The provided 510(k) summary does not include a table of specific quantitative acceptance criteria (e.g., specific luminance levels, contrast ratios, or color accuracy metrics) or a study reporting the device's performance against such criteria. The submission primarily relies on demonstrating substantial equivalence to a predicate device.

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

Not applicable. This 510(k) summary for a medical monitor does not describe a clinical performance study with a test set of data/images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This 510(k) summary for a medical monitor does not describe a clinical performance study with ground truth established by experts.

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

Not applicable. This 510(k) summary for a medical monitor does not describe a clinical performance study 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

Not applicable. This 510(k) summary is for a medical display monitor, not an AI-powered diagnostic algorithm. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted.

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 a diagnostic algorithm.

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

Not applicable. This 510(k) submission for a display monitor does not involve a clinical study requiring ground truth for diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device is a display monitor and does not involve machine learning or a training set.

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

Not applicable. This device is a display monitor and does not involve machine learning or a training set with ground truth.

Summary of Device and Evidence Presented in 510(k):

The 510(k) submission for the 21.3-inch (54 cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) establishes substantial equivalence to its predicate device, the 3M Color LCD Monitor CDL2119A (CCL352i2) (K072065).

The basis for acceptance (regulatory clearance) is the demonstration of substantial equivalence. The argument for substantial equivalence is that the new device shares the "same characteristics" as the predicate device, with differences only in power supply, front bezel, frame, fan, PCB, and LCD screen. These differences are presumably not considered to affect the fundamental performance parameters relevant to its intended use for displaying and viewing medical images for diagnosis.

No specific quantitative acceptance criteria or detailed performance study results are provided in the excerpt. The regulatory submission relies on the established equivalence to a previously cleared device that meets the general controls and requirements for medical image display.

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